Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Paclitaxel or Polyglutamate Paclitaxel or Observation in Treating Patients With Stage III or Stage IV Ovarian Epithelial or Peritoneal Cancer or Fallopian Tube Cancer

Basic Trial Information

Objectives

Primary

1. Compare overall survival of patients with stage III or IV ovarian epithelial or primary peritoneal cancer or fallopian tube cancer in clinical complete response after prior primary platinum and taxane-based chemotherapy treated with paclitaxel vs polyglutamate paclitaxel as consolidation/maintenance therapy vs no further anticancer therapy until documented disease progression.

Secondary

1. Compare progression-free survival of patients treated with these drugs.
2. Compare the toxicity profile of these drugs, particularly peripheral neuropathy, in these patients.
3. Compare the quality of life of patients treated with these drugs.

Tertiary

1. Correlate angiogenic marker expression with overall or progression-free survival of patients treated with these drugs.

Entry Criteria

Disease Characteristics:

• Histologically confirmed stage III or IV ovarian epithelial or primary peritoneal cancer or fallopian tube cancer

• The following histologic epithelial cell types are allowed:
  • Serous adenocarcinoma
  • Endometrioid adenocarcinoma
  • Mucinous adenocarcinoma
  • Undifferentiated carcinoma
  • Clear cell adenocarcinoma
  • Mixed epithelial carcinoma
  • Transitional cell carcinoma
  • Malignant Brenner tumor
  • Adenocarcinoma not otherwise specified

• The following histologic cell types are not allowed:
  • Germ cell tumor
  • Sex cord-stromal tumor
  • Carcinosarcoma
  • Mixed müllerian tumor or carcinosarcoma
  • Metastatic carcinoma from other sites to the ovary
  • Low malignant potential (LMP) tumor (borderline carcinoma), including micropapillary serous carcinoma
    • Patients with a prior diagnosis of LMP tumor that was surgically resected and who subsequently developed invasive adenocarcinoma are eligible provided patient did not receive prior chemotherapy for the ovarian LMP tumor

• Must have undergone surgery for ovarian epithelial or primary peritoneal cancer AND have tissue available for histologic evaluation
  • Optimal (≤ 1 cm) residual disease OR suboptimal residual disease after initial surgery

• Must have completed at least 5, but no more that 8 courses of primary therapy comprising carboplatin (IV or intraperitoneal) AND paclitaxel or docetaxel-based combination chemotherapy within the past 12 weeks AND have no symptoms of persistent cancer after completion of therapy
  • CT scan of the abdomen and/or pelvis normal
  • CA 125 normal

• Patients treated with neo-adjuvant platinum-taxane chemotherapy for a presumptive diagnosis of stage III or IV primary peritoneal carcinoma or epithelial ovarian carcinoma (by paracentesis, percutaneous biopsy or open biopsy) are eligible provided the following criteria is met:
  • Must have undergone interval abdominal surgery after at least one but no more than 6 courses of standard chemotherapy
    • Surgery must meet the same criteria as the up front surgery, including tissue diagnosis for confirmation of primary tumor site and stage III or IV disease
    • Patients must have received at least 2 courses after interval abdominal surgery

• No synchronous primary endometrial cancer or history of primary endometrial cancer, unless all of the following criteria are met:
  • Stage ≤ IB
  • Less than 3 mm invasion without vascular or lymphatic invasion
  • No poorly differentiated subtypes, including papillary serous, clear cell, or other FIGO grade 3 lesion

Prior/Concurrent Therapy:

Biologic therapy

• No prior biologic therapy (e.g., bevacizumab or erlotinib) for any other abdominal or pelvic tumor

Chemotherapy

• See Disease Characteristics
• No prior polyglutamate paclitaxel
• No prior chemotherapy for any other abdominal or pelvic tumor
• More than 3 years since prior adjuvant chemotherapy for localized breast cancer AND no recurrent or metastatic disease

Endocrine therapy

• Not specified

Radiotherapy

• No prior radiotherapy to any portion of the abdominal cavity or pelvis
• More than 3 years since prior radiotherapy for localized cancer of the breast, head and neck, or skin AND no recurrent or metastatic disease

Surgery

• See Disease Characteristics

Other

• No prior investigational therapy for any other abdominal or pelvic tumor
• No prior anticancer therapy that would preclude study therapy
• No concurrent amifostine or other protective agents

Patient Characteristics:

Age

• Not specified

Performance status

• GOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• No active bleeding

Hepatic

• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• SGOT ≤ 2.5 times ULN
• Alkaline phosphatase ≤ 2.5 times ULN
• PT or PTT normal
• No acute or chronic hepatitis

Renal

• Creatinine ≤ 1.5 times ULN

Cardiovascular

• Abnormal cardiac conduction (e.g., bundle branch block or heart block) allowed provided the disease has remained stable within the past 6 months
• No unstable angina
• No myocardial infarction within the past 6 months

Other

• No neuropathy (sensory and motor) ≥ grade 2
• No active infection requiring antibiotics
• No ongoing gastrointestinal bleeding requiring blood product support
• No circumstance that would preclude study participation
• No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
• Not pregnant or nursing
• Fertile patients must agree to use an effective contraception method
• Negative pregnancy test

Expected Enrollment

A total of 1,110 patients (555 per treatment arm) will be accrued for this study within 8.5 years.

Outcomes

Overall survival

Peripheral neuropathy by Gynecologic Oncology Group (GOG) NTX4 at 6 months after study enrollment
General quality of life by Functional Assessment of Cancer Therapy-Ovarian-Trial Outcome Index (FACT-O-TOI) at 6 months after study enrollment
Exploratory assessment of several tissue and serum angiogenic markers for prognosis by immunohistochemistry and antibody array prior to treatment in courses 1 and 2
Exploratory time-dependent assessment of quality of life and peripheral neuropathy by FACT-O-TOI and GOG-NTX4 monthly during year 1 and then every 3 months for 2 years

Outline

This is a randomized, multicenter study. Patients are stratified according to disease stage at diagnosis (stage III vs stage IV); presence of macroscopic disease after initial debulking surgery (yes vs no); type of prior taxane-based therapy (docetaxel vs paclitaxel); and route of prior platinum therapy (intraperitoneal vs IV). Patients are randomized to 1 of 3 treatment arms.

• Arm I: Patients receive polyglutamate paclitaxel IV over 10-20 minutes on day 1.

• Arm II: Patients receive paclitaxel IV over 3 hours on day 1.

• Arm III: Patients receive no further anticancer treatment until evidence of disease progression.

In arms I and II, treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, before courses 3, 5, and 7 of study treatment, at completion of study treatment, and then at 1 year after completion of study treatment.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.

Trial Contact Information

Trial Lead Organizations

Gynecologic Oncology Group

Larry Copeland, MD, Protocol chair		Ph: 614-293-8697 Email: larry.copeland@osumc.edu
Robert Burger, MD, Protocol co-chair		Ph: 714-456-7971 Email: raburger@uci.edu

U.S.A.
Alabama
	Birmingham
	UAB Comprehensive Cancer Center
		Clinical Trials Office - UAB Comprehensive Cancer Center	Ph:  205-934-0309
Arizona
	Phoenix
	St. Joseph's Hospital and Medical Center
		Ivor Benjamin	Ph:  602-406-3000
	Scottsdale
	Mayo Clinic Scottsdale
		Clinical Trials Office - All Mayo Clinic Locations	Ph:  507-538-7623
Arkansas
	Little Rock
	Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
		Clinical Trial Office - Arkansas Cancer Research Center at University of Arkansas for Medical Sciences	Ph:  501-686-8274
California
	Burbank
	Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center
		Clinical Trials Office - Providence Saint Joseph Medical Center - Burbank	Ph:  818-847-3220
	La Jolla
	Rebecca and John Moores UCSD Cancer Center
		Clinical Trials Office - Rebecca and John Moores UCSD Cancer Center	Ph:  858-822-5354
			Email: cancercto@ucsd.edu
	Long Beach
	Todd Cancer Institute at Long Beach Memorial Medical Center
		Robert Bristow	Ph:  562-933-0900
	Los Angeles
	Jonsson Comprehensive Cancer Center at UCLA
		Clinical Trials Office - Jonsson Comprehensive Cancer Center at UCLA	Ph:  888-798-0719
	Kaiser Permanente Medical Center - Los Angeles
		Scott Lentz, MD	Ph:  323-783-4018
	Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
		Ilana Cass	Ph:  310-423-3277
	Mountain View
	Palo Alto Medical Foundation
		Albert Pisani	Ph:  650-934-7000
	Orange
	Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
		Clinical Trials Office - Chao Family Comprehensive Cancer Center	Ph:  877-UC-STUDY
			Email: ucstudy@uci.edu
Colorado
	Boulder
	Boulder Community Hospital
		Clinical Trials Office - Boulder Community Hospital	Ph:  303-938-5253
	Colorado Springs
	Penrose Cancer Center at Penrose Hospital
		Clinical Trials Office - Penrose Cancer Center	Ph:  719-776-5275
	Denver
	CCOP - Colorado Cancer Research Program
		Eduardo Pajon, MD	Ph:  303-399-8020ext2261
	Porter Adventist Hospital
		Eduardo Pajon, MD	Ph:  303-399-8020ext2261
	Rose Medical Center
		Eduardo Pajon, MD	Ph:  303-399-8020ext2261
	St. Joseph Hospital
		Eduardo Pajon, MD	Ph:  303-399-8020ext2261
	Englewood
	Rocky Mountain Gynecologic Oncology
		Kevin Davis, MD	Ph:  303-781-9090
	Grand Junction
	St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
		Eduardo Pajon, MD	Ph:  303-399-8020ext2261
	Greeley
	North Colorado Medical Center
		Eduardo Pajon, MD	Ph:  303-399-8020ext2261
	Wheat Ridge
	Exempla Lutheran Medical Center
		Clinical Trials Office - Exempla Lutheran Medical Center	Ph:  303-403-3605
Connecticut
	Farmington
	Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
		Clinical Trials Office - Carole and Ray Neag Comprehensive Cancer Center	Ph:  800-579-7822
	Hartford
	Helen and Harry Gray Cancer Center at Hartford Hospital
		Clinical Trials Office - Helen and Harry Gray Cancer Center	Ph:  860-545-5363
	Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
		Philip Stella, MD	Ph:  734-712-1000
	New Britain
	George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
		Clinical Trials Office - George Bray Cancer Center	Ph:  860-224-5660
Delaware
	Lewes
	Tunnell Cancer Center at Beebe Medical Center
		Clinical Trials Office - Tunnell Cancer Center	Ph:  302-645-3171
	Newark
	CCOP - Christiana Care Health Services
		Clinical Trial Office - CCOP - Christiana Care Health Services	Ph:  302-623-4450
Florida
	Clearwater
	Morton Plant Hospital
		Hector Arango, MD	Ph:  727-446-2111
	Fort Myers
	Florida Gynecologic Oncology - Fort Myers
		Edward Grendys, MD	Ph:  239-992-0077
	Jacksonville
	Mayo Clinic - Jacksonville
		Clinical Trials Office - All Mayo Clinic Locations	Ph:  507-538-7623
	Orlando
	Florida Hospital Cancer Institute at Florida Hospital Orlando
		Clinical Trials Office - Florida Hospital Cancer Institute	Ph:  407-303-5623
	M.D. Anderson Cancer Center at Orlando
		Veronica Schimp	Ph:  407-648-3800 800-648-3818
	Saint Petersburg
	Women's Cancer Associates
		James LaPolla, MD	Ph:  727-821-9688
	Sarasota
	Sarasota Memorial Hospital
		Clinical Trials Office - Sarasota Memorial Hospital	Ph:  941-917-2225
Georgia
	Columbus
	John B. Amos Cancer Center
		Clinical Trials Office - John B. Amos Cancer Center	Ph:  706-660-6404
	Gainesville
	Northeast Georgia Medical Center
		Andrew Green	Ph:  770-535-3553
	Macon
	Central Georgia Gynecologic Oncology
		Gary Eddy, MD	Ph:  476-633-6090
	Savannah
	Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
		Clinical Trials Office - Curtis and Elizabeth Anderson Cancer Institute	Ph:  912-350-8568
Illinois
	Chicago
	Robert H. Lurie Comprehensive Cancer Center at Northwestern University
		Clinical Trials Office - Robert H. Lurie Comprehensive Cancer Center at Northwestern University	Ph:  312-695-1301
			Email: cancer@northwestern.edu
	Rush University Medical Center
		Clinical Trials Office - Rush University Medical Center	Ph:  312-942-5498
			Email: clinical_trials@rush.edu
	University of Illinois Cancer Center
		Clinical Trial Office - University of Illinois Cancer Center	Ph:  312-355-3046
	Decatur
	Decatur Memorial Hospital Cancer Care Institute
		Clinical Trials Office - Decatur Memorial Hospital Cancer Care Institute	Ph:  217-876-4750
	Hinsdale
	Gynecologic Oncology
		Sudarshan Sharma, MD	Ph:  630-856-6757
	Park Ridge
	Advocate Lutheran General Cancer Care Center
		Clinical Trials Office - Advocate Lutheran General Cancer Care Center	Ph:  847-384-3621
	Springfield
	Regional Cancer Center at Memorial Medical Center
		Clinical Trials Office - Regional Cancer Center at Memorial Medical Center	Ph:  217-788-4233
	Urbana
	CCOP - Carle Cancer Center
		Clinical Trials Office - CCOP - Carle Cancer Center	Ph:  800-446-5532
	Warrenville
	Central Dupage Cancer Center
		Laura Horvath	Ph:  630-933-1600
Indiana
	Elkhart
	Elkhart General Hospital
		Michael Method, MD, MPH	Ph:  574-237-1328
	Michiana Hematology-Oncology, PC - Elkhart
		Michael Method, MD, MPH	Ph:  574-237-1328
	Indianapolis
	Gynecologic Oncology of Indiana
		David Moore	Ph:  317-851-2555
	Indiana University Melvin and Bren Simon Cancer Center
		Clinical Trials Office - Indiana University Cancer Center	Ph:  317-274-2552
	Kokomo
	Howard Community Hospital
		Michael Method, MD, MPH	Ph:  574-237-1328
	La Porte
	Center for Cancer Therapy at LaPorte Hospital and Health Services
		Michael Method, MD, MPH	Ph:  574-237-1328
	Mishawaka
	Michiana Hematology-Oncology, PC - South Bend
		Michael Method, MD, MPH	Ph:  574-237-1328
	Saint Joseph Regional Medical Center
		Michael Method, MD, MPH	Ph:  574-237-1328
	South Bend
	CCOP - Northern Indiana CR Consortium
		Michael Method, MD, MPH	Ph:  574-237-1328
	Memorial Hospital of South Bend
		Clinical Trials Office - Memorial Hospital of South Bend	Ph:  800-284-7370
	Michiana Hematology-Oncology, PC - South Bend
		Michael Method, MD, MPH	Ph:  574-237-1328
	Westville
	Michiana Hematology Oncology PC - La Porte
		Michael Method, MD, MPH	Ph:  574-237-1328
Iowa
	Iowa City
	Holden Comprehensive Cancer Center at University of Iowa
		Cancer Information Service	Ph:  800-237-1225
Kansas
	Chanute
	Cancer Center of Kansas, PA - Chanute
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Dodge City
	Cancer Center of Kansas, PA - Dodge City
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	El Dorado
	Cancer Center of Kansas, PA - El Dorado
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Fort Scott
	Cancer Center of Kansas - Fort Scott
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Independence
	Cancer Center of Kansas-Independence
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Kansas City
	Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
		Clinical Trials Office - Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center	Ph:  913-588-4709
	Kingman
	Cancer Center of Kansas, PA - Kingman
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Newton
	Cancer Center of Kansas, PA - Newton
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Parsons
	Cancer Center of Kansas, PA - Parsons
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Prairie Village
	CCOP - Kansas City
		Rakesh Gaur, MD	Ph:  913-948-5588
	Pratt
	Cancer Center of Kansas, PA - Pratt
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Wellington
	Cancer Center of Kansas, PA - Wellington
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Wichita
	Associates in Womens Health, PA - North Review
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Cancer Center of Kansas, PA - Wichita
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Cancer Center of Kansas, PA - Medical Arts Tower
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	CCOP - Wichita
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Via Christi Cancer Center at Via Christi Regional Medical Center
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Winfield
	Cancer Center of Kansas, PA - Winfield
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
Kentucky
	Lexington
	Central Baptist Hospital
		Clinical Trials Office - Central Baptist Hospital	Ph:  859-260-6425
	Lucille P. Markey Cancer Center at University of Kentucky
		Clinical Trials Office - Markey Cancer Center at University of Kentucky Chandler Medical Center	Ph:  859-257-3379
	Louisville
	Louisville Oncology at Norton Cancer Institute - Louisville
		Clinical Trials Office - Louisville Oncology	Ph:  502-629-2500
Louisiana
	Alexandria
	Tulane Cancer Center Office of Clinical Research
		Clinical Trials Office - Tulane Cancer Center	Ph:  504-988-6121
	Shreveport
	Christus Schumpert Cancer Treatment Center
		Clinical Trials Office - Christus Schumpert Cancer Treatment Center	Ph:  318-681-4763
	Feist-Weiller Cancer Center at Louisiana State University Health Sciences
		Clinical Trials Office - Feist-Weiller Cancer Center at Louisiana State University Health Sciences	Ph:  318-813-1412
Maryland
	Baltimore
	Greenebaum Cancer Center at University of Maryland Medical Center
		Clinical Trials Office - Greenebaum Cancer Center at University of Maryladn Medical Center	Ph:  800-888-8823
	Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center
		Clinical Trials Office - Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center	Ph:  443-777-7364
	Elkton MD
	Union Hospital of Cecil County
		Mark Borowsky	Ph:  410-398-4000
Massachusetts
	Boston
	Tufts Medical Center Cancer Center
		Michael Kelly	Ph:  617-636-6100
	Springfield
	Baystate Regional Cancer Program at D'Amour Center for Cancer Care
		Tashanna Myers	Ph:  413-794-9338
	Worcester
	UMASS Memorial Cancer Center - University Campus
		Susan Zweizig, MD	Ph:  508-334-1160
Michigan
	Ann Arbor
	Saint Joseph Mercy Cancer Center
		Philip Stella, MD	Ph:  734-712-1000
	University of Michigan Comprehensive Cancer Center
		Clinical Trials Office - University of Michigan Comprehensive Cancer Center	Ph:  800-865-1125
	Battle Creek
	Battle Creek Health System Cancer Care Center
		Martin Bury	Ph:  616-966-8000
	Big Rapids
	Mecosta County Medical Center
		Martin Bury	Ph:  231-796-8691
	Detroit
	Josephine Ford Cancer Center at Henry Ford Hospital
		Thomas Buekers	Ph:  313-916-1850 888-734-5322
	Grand Rapids
	Butterworth Hospital at Spectrum Health
		Martin Bury	Ph:  616-391-2799
	CCOP - Grand Rapids
		Martin Bury	Ph:  616-391-1230
	Gynecologic Oncology of West Michigan
		Gordon Downey, MD	Ph:  616-957-3398
	Lacks Cancer Center at Saint Mary's Health Care
		Martin Bury	Ph:  616-752-5222
	Kalamazoo
	Borgess Medical Center
		Raymond Lord, MD	Ph:  269-373-7458
	Bronson Methodist Hospital
		Raymond Lord, MD	Ph:  269-373-7458
	West Michigan Cancer Center
		Clinical Trials Office - West Michigan Cancer Center	Ph:  269-373-7458
	Muskegon
	Mercy General Health Partners
		Martin Bury	Ph:  231-672-2000
	Niles
	Michiana Hematology Oncology PC - Niles
		Michael Method, MD, MPH	Ph:  574-237-1328
	Royal Oak
	William Beaumont Hospital - Royal Oak Campus
		Clinical Trials Office - William Beaumont Hospital - Royal Oak Campus	Ph:  248-551-7695
	St. Joseph
	Lakeland Regional Cancer Care Center - St. Joseph
		Michael Method, MD, MPH	Ph:  574-237-1328
	Traverse City
	Munson Medical Center
		Martin Bury	Ph:  231-935-6202
Minnesota
	Coon Rapids
	Mercy and Unity Cancer Center at Mercy Hospital
		Patrick Flynn, MD	Ph:  612-863-8585
	Duluth
	St. Luke's Hospital Cancer Care Center
		Tanya Repka, MD, FACP	Ph:  218-726-3081
	Edina
	Fairview Southdale Hospital
		Clinical Trials Office - Fairview Southdale Hospital	Ph:  612-625-3650
	Fridley
	Mercy and Unity Cancer Center at Unity Hospital
		Patrick Flynn, MD	Ph:  612-863-8585
	Maplewood
	Minnesota Oncology Hematology, PA - Maplewood
		Patrick Flynn, MD	Ph:  612-863-8585
	Minneapolis
	Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
		Clinical Trials Office - Virginia Piper Cancer Institute	Ph:  612-863-5654
	Robbinsdale
	Humphrey Cancer Center at North Memorial Outpatient Center
		Clinical Trials Office - Humphrey Cancer Center at North Memorial Outpatient Center	Ph:  763-520-1893
	Rochester
	Mayo Clinic Cancer Center
		Clinical Trials Office - All Mayo Clinic Locations	Ph:  507-538-7623
	Saint Louis Park
	CCOP - Metro-Minnesota
		Patrick Flynn, MD	Ph:  612-863-8585
	Park Nicollet Cancer Center
		Patrick Flynn, MD	Ph:  612-863-8585
	Saint Paul
	United Hospital
		Patrick Flynn, MD	Ph:  612-863-8585
	St. Paul
	Regions Hospital Cancer Care Center
		Clinical Trials Office - Regions Hospital Cancer Care Center	Ph:  651-254-1517
	Woodbury
	Minnesota Oncology Hematology, PA - Woodbury
		Patrick Flynn, MD	Ph:  612-863-8585
Mississippi
	Jackson
	St. Dominic Cancer Center
		Donald Seago	Ph:  601-200-3070
	University of Mississippi Cancer Clinic
		James Thigpen, MD	Ph:  601-984-5590
	Pascagoula
	Regional Cancer Center at Singing River Hospital
		James Clarkson, MD	Ph:  228-374-6296
Missouri
	Joplin
	Freeman Cancer Institute at Freeman Health System
		David Ross	Ph:  417-347-3066
	Kansas City
	Research Medical Center
		Rakesh Gaur, MD	Ph:  913-948-5588
	Saint Louis
	David C. Pratt Cancer Center at St. John's Mercy
		Clinical Trials Office - David C. Pratt Cancer Center at St. John's Mercy	Ph:  314-251-6770
	Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
		David Mutch, MD	Ph:  314-362-3181
	Springfield
	Hulston Cancer Center at Cox Medical Center South
		Robert Carolla	Ph:  417-269-5257
Nebraska
	Omaha
	Methodist Estabrook Cancer Center
		Peter Morris, MD	Ph:  402-354-5250
	UNMC Eppley Cancer Center at the University of Nebraska Medical Center
		Clinical Trials Office - UNMC Eppley Cancer Center at the University of Nebraska Medical Center	Ph:  800-999-5465
Nevada
	Las Vegas
	Women's Cancer Center - La Canada
		Nick Spirtos, MD	Ph:  408-866-3843
	Reno
	Renown Institute for Cancer at Renown Regional Medical Center
		Peter Lim	Ph:  775-982-5050 866-559-0558
New Hampshire
	Lebanon
	Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
		Clinical Trials Office - Norris Cotton Cancer Center	Ph:  603-650-7609
			Email: cancerhelp@dartmouth.edu
New Jersey
	Neptune
	Jersey Shore Cancer Center at Jersey Shore University Medical Center
		Henry Sprance, MD, PhD	Ph:  732-776-4128
	Voorhees
	Cancer Institute of New Jersey at Cooper - Voorhees
		Clinical Trials Office - Cancer Institute of New Jersey at Cooper University Hospital - Voorhees	Ph:  856-325-6757
New Mexico
	Albuquerque
	Southwest Gynecologic Oncology Associates, Incorporated
		Carolyn Muller, MD	Ph:  505-272-0185
	University of New Mexico Cancer Center
		Clinical Trials Office - University of New Mexico Cancer Center	Ph:  505-272-6972
New York
	Brightwaters
	Schwartz Gynecologic Oncology
		Benjamin Schwartz	Ph:  631-376-0055
	Buffalo
	Roswell Park Cancer Institute
		Clinical Trials Office - Roswell Park Cancer Institute	Ph:  877-275-7724
	Fresh Meadows
	New York Hospital Medical Center of Queens - Fresh Meadows
		Manolis Tsatsas	Ph:  718-670-1170
	Lake Success
	Monter Cancer Center of the North Shore-LIJ Health System
		Veena John	Ph:  516-734-8959
	Manhasset
	Don Monti Comprehensive Cancer Center at North Shore University Hospital
		Clinical Trials Office - Don Monti Comprehensive Cancer Center at North Shore University Hospital	Ph:  516-734-8900
	Mineola
	Winthrop University Hospital
		Jeannine Villella	Ph:  516-663-9500
	New Hyde Park
	Long Island Jewish Medical Center
		Veena John	Ph:  718-470-7000 800-371-7111
	New York
	Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
		Clinical Trials Office - Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center	Ph:  212-305-8615
	Mount Sinai Medical Center
		Monica Hayes	Ph:  212-241-6500
	Stony Brook
	Stony Brook University Cancer Center
		Clinical Trials Office - Stony Brook University Cancer Center	Ph:  800-862-2215
	Syracuse
	SUNY Upstate Medical University Hospital
		Clinical Trials Office - SUNY Upstate Medical University Hospital	Ph:  315-464-5476
North Carolina
	Asheville
	Hope A Women's Cancer Center
		Timothy Vanderkwaak	Ph:  828-670-8403
	Burlington
	Alamance Cancer Center at Alamance Regional Medical Center
		Janak Choksi, MD	Ph:  336-538-7737
	Charlotte
	Presbyterian Cancer Center at Presbyterian Hospital
		Clinical Trials Office - Presbyterian Cancer Center at Presbyterian Hospital	Ph:  704-384-5369
	Durham
	Duke Cancer Institute
		Clinical Trials Office - Duke Cancer Institute	Ph:  888-275-3853
	Greensboro
	Moses Cone Regional Cancer Center at Wesley Long Community Hospital
		Clinical Trials Office - Moses Cone Regional Cancer Center at Wesley Long Community Hospital	Ph:  336-621-8374
	Rutherfordton
	Rutherford Hospital
		David Griffin	Ph:  828-286-5000
	Wilmington
	Zimmer Cancer Center at New Hanover Regional Medical Center
		Walter Gajewski, MD	Ph:  910-342-3000
	Winston-Salem
	Wake Forest University Comprehensive Cancer Center
		Clinical Trials Office - Wake Forest University Comprehensive Cancer Center	Ph:  336-713-6771
Ohio
	Akron
	McDowell Cancer Center at Akron General Medical Center
		Eric Jenison, MD	Ph:  330-344-6041
	Summa Center for Cancer Care at Akron City Hospital
		Clinical Trials Office - Akron City Hospital	Ph:  330-375-6101
	Canton
	Aultman Cancer Center at Aultman Hospital
		Clinical Trials Office - Aultman Cancer Center at Aultman Hospital	Ph:  330-363-6891
	Cincinnati
	Charles M. Barrett Cancer Center at University Hospital
		William Richards	Ph:  806-796-1317
	Cleveland
	Case Comprehensive Cancer Center
		Clinical Trials Office - Case Comprehensive Cancer Center	Ph:  800-641-2422
	MetroHealth Cancer Care Center at MetroHealth Medical Center
		Peter Rose, MD	Ph:  216-444-1712
	Columbus
	Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
		Ohio State University Cancer Clinical Trial Matching Service	Ph:  866-627-7616
			Email: osu@emergingmed.com
	Riverside Methodist Hospital Cancer Care
		Clinical Trials Office - Riverside Methodist Hospital Cancer Care	Ph:  614-566-4475
	Dayton
	David L. Rike Cancer Center at Miami Valley Hospital
		Clinical Trials Office - David L. Rike Cancer Center at Miami Valley Hospital	Ph:  937-208-2079
	Mentor
	Lake/University Ireland Cancer Center
		Steven Waggoner, MD	Ph:  216-844-5011
Oklahoma
	Oklahoma City
	Oklahoma University Cancer Institute
		Robert Mannel, MD	Ph:  405-271-8787
	Tulsa
	Cancer Care Associates - Saint Francis Campus
		Robert Mannel, MD	Ph:  405-271-8787
Oregon
	Portland
	Northwest Cancer Specialists at Rose Quarter Cancer Center
		William Winter, III	Ph:  503-228-6509
Pennsylvania
	Abington
	Rosenfeld Cancer Center at Abington Memorial Hospital
		Clinical Trials Office - Rosenfeld Cancer Center at Abington Memorial Hospital	Ph:  215-481-2402
	Danville
	Geisinger Cancer Institute at Geisinger Health
		Clinical Trials Office - Geisinger Cancer Institute	Ph:  570-271-5251
	Hazleton
	Geisinger Hazleton Cancer Center
		James Bosscher	Ph:  570-459-2901
	Hershey
	Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center
		Clinical Trials Office - Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center	Ph:  717-531-3779
			Email: CTO@hmc.psu.edu
	Philadelphia
	Abramson Cancer Center of the University of Pennsylvania
		Clinical Trials Office - Abramson Cancer Center of the University of Pennsylvania	Ph:  800-474-9892
	Pittsburgh
	UPMC Cancer Center at Magee-Womens Hospital
		Clinical Trials Office - UPMC Cancer Center at Magee-Womens Hospital	Ph:  412-647-2811
	Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
		Eileen Segreti, MD	Ph:  412-578-1116
	Reading
	McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
		Clinical Trials Office - McGlinn Family Regional Cancer Center	Ph:  610-988-9323
	State College
	Geisinger Medical Group - Scenery Park
		James Bosscher	Ph:  814-231-4560
	Wilkes-Barre
	Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
		Clinical Trials Office - Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center	Ph:  570-271-5251
Rhode Island
	Providence
	Women and Infants Hospital of Rhode Island
		Clinical Trials Office - Women and Infants Hospital of Rhode Island	Ph:  401-274-1122
South Carolina
	Spartanburg
	CCOP - Upstate Carolina
		Clinical Trials Office - CCOP - Upstate Carolina	Ph:  800-486-5941
South Dakota
	Rapid City
	Black Hills Obstetrics & Gynecology LLP
		Helen Frederickson, MD	Ph:  605-343-9224
	Sioux Falls
	Avera Cancer Institute
		Luis Rojas-Espaillat	Ph:  605-322-3000
	Sanford Cancer Center at Sanford USD Medical Center
		Clinical Trials Office - Sanford Cancer Center	Ph:  605-328-1367
Tennessee
	Chattanooga
	Chattanooga Gyn-Oncology
		Donald Chamberlain, MD, FACS, FACOG	Ph:  423-698-2050
	Chattanooga's Program in Women's Oncology
		Stephen DePasquale	Ph:  423-266-3636
Texas
	Dallas
	Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
		Clinical Trials Office - Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas	Ph:  866-460-4673; 214-648-7097
	Fort Sam Houston
	Brooke Army Medical Center
		Clinical Trials Office - Brooke Army Medical Center	Ph:  210-916-4837
	Galveston
	University of Texas Medical Branch
		Clinical Trials Office - University of Texas Medical Branch	Ph:  409-772-1950
	Houston
	Lyndon B. Johnson General Hospital
		Lois Ramondetta	Ph:  713-745-0307
	M. D. Anderson Cancer Center at University of Texas
		Clinical Trials Office - M. D. Anderson Cancer Center at the University of Texas	Ph:  713-792-3245
	Methodist Hospital
		Tri Dinh	Ph:  713-441-1010
Vermont
	Burlington
	Fletcher Allen Health Care - University Health Center Campus
		Clinical Trials Office - Fletcher Allen Health Care	Ph:  802-656-8990
Virginia
	Annandale
	Northern Virginia Pelvic Surgery Associates
		John Elkas	Ph:  202-782-8513
	Charlottesville
	University of Virginia Cancer Center
		Susan Modesitt	Ph:  434-924-9333 800-223-9173
	Norfolk
	Virginia Oncology Associates - Lake Wright
		Robert Squatrito, MD	Ph:  757-466-1466
	Richmond
	Virginia Commonwealth University Massey Cancer Center
		Clinical Trials Office -Virginia Commonwealth University Massey Cancer Center	Ph:  804-628-1939
Washington
	Mount Vernon
	Skagit Valley Hospital Cancer Care Center
		Benjamin Greer, MD	Ph:  206-685-2463
	Seattle
	CCOP - Virginia Mason Research Center
		Thomas Malpass	Ph:  206-341-0446
	Fred Hutchinson Cancer Research Center
		Benjamin Greer, MD	Ph:  206-685-2463
	Northwest Hospital and Medical Center
		Benjamin Greer, MD	Ph:  206-685-2463
	Pacific Gynecology Specialists
		Benjamin Greer, MD	Ph:  206-685-2463
	Seattle Cancer Care Alliance
		Clinical Trials Office - Seattle Cancer Care Alliance	Ph:  800-804-8824
	Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
		Benjamin Greer, MD	Ph:  206-685-2463
	University Cancer Center at University of Washington Medical Center
		Benjamin Greer, MD	Ph:  206-685-2463
	Spokane
	Cancer Care Northwest - Spokane South
		Clinical Trials Office - Cancer Care Northwest - Spokane South	Ph:  509-228-1083
	Tacoma
	MultiCare Regional Cancer Center at Tacoma General Hospital
		Clinical Trials Office - MultiCare Regional Cancer Center	Ph:  253-403-3229
	Walla Walla
	St. Mary Regional Cancer Center at St. Mary Medical Center
		Benjamin Greer, MD	Ph:  206-685-2463
Wisconsin
	Green Bay
	St. Vincent Hospital Regional Cancer Center
		Clinical Trials Office - St. Vincent Hospital Regional Cancer Center	Ph:  920-433-8889
	Madison
	University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
		Clinical Trials Office - University of Wisconsin Paul P. Carbone Comprehensive Cancer Center	Ph:  608-262-5223
	Milwaukee
	Medical College of Wisconsin Cancer Center
		Clinical Trials Office - Medical College of Wisconsin Cancer Center	Ph:  414-805-4380
	Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
		Clinical Trials Office - Vince Lombardi Cancer Clinic	Ph:  414-649-5717
	Sheboygan
	Vince Lombardi Cancer Clinic - Sheboygan
		Clinical Trials Office - Vince Lombardi Cancer Clinic - Sheboygan	Ph:  414-649-7200
	Waukesha
	Waukesha Memorial Hospital Regional Cancer Center
		Clinical Trials Office - Waukesha Memorial Hospital Regional Cancer Center	Ph:  262-928-7632
	West Allis
	Aurora Women's Pavilion of West Allis Memorial Hospital
		Peter Johnson, MD (Contact information may not be current)	Ph:  262-549-6662

Registry Information
Official Title		A Randomized Phase III Trial of Maintenance Chemotherapy Comparing 12 Monthly Cycles of Single Agent Paclitaxel or XyotaxTM (CT-2103) (IND# 70177), Versus No Treatment Until Documented Relapse in Women with Advanced Ovarian or Primary Peritoneal or Fallopian Tube Cancer Who Achieve a Complete Clinical Response to Primary Platinum/Taxane Chemotherapy
Trial Start Date		2005-03-21
Trial Completion Date		2008-04-01 (estimated)
Registered in ClinicalTrials.gov		NCT00108745
Date Submitted to PDQ		2005-02-17
Information Last Verified		2012-02-11
NCI Grant/Contract Number		CA27469

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