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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Active	Not specified	NCI	GOG-0212 NCT00108745

Objectives

Primary

1. Compare overall survival of patients with stage III or IV ovarian epithelial or primary peritoneal 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 ovarian epithelial or primary peritoneal cancer
  • Stage III or IV disease



• 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

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

Maurie Markman, MD, Protocol chair		Ph: 713-745-7140; 800-392-1611
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 - Lurleen Wallace Comprehensive Cancer	Ph:  205-934-0309
Arizona
	Scottsdale
	Mayo Clinic Scottsdale
		Clinical Trials Office - All Mayo Clinic Locations	Ph:  507-538-7623
Arkansas
	Fayetteville
	Highlands Oncology Group - Fayetteville
		Randall Hightower, MD	Ph:  479-575-9000
	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
	Providence Saint Joseph Medical Center - Burbank
		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
		Krishnansu Tewari	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
	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
	Sacramento
	University of California Davis Cancer Center
		Clinical Trials Office - University of California Davis Cancer Center	Ph:  916-734-3089
Colorado
	Aurora
	Colorado Gynecologic Oncology Group, PC
		Susan Davidson, MD	Ph:  303-315-7897
	Boulder
	Boulder Community Hospital
		Clinical Trials Office - Boulder Community Hospital	Ph:  303-938-5253
	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
	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
	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
		Allan Mayer, DO	Ph:  860-714-7945
	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
	New Haven
	Yale Cancer Center
		Clinical Trials Office - Yale Cancer Center	Ph:  203-785-5702
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:  302-733-6227
District of Columbia
	Washington
	Walter Reed Army Medical Center
		Clinical Trials Office - Walter Reed Army Medical Center	Ph:  202-782-7840
Florida
	Clearwater
	Morton Plant Hospital
		Hector Arango, MD	Ph:  727-446-2111
	Fort Lauderdale
	Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
		Clinical Trials Office - Michael and Dianne Bienes Comprehensive Cancer Center	Ph:  954-776-3239
	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
	St. Vincent's Medical Center
		Stephen Buckley, MD	Ph:  904-389-3993
	Jupiter
	Ella Milbank Foshay Cancer Center at Jupiter Medical Center
		Clinical Trials Office - Ella Milbank Foshay Cancer Center	Ph:  561-745-5768
	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
		Jennifer Tseng, MD	Ph:  321-841-1882
	Saint Petersburg
	Bayfront Cancer Care Center at Bayfront Medical Center
		James LaPolla, MD	Ph:  727-821-9688
	Sarasota
	Sarasota Memorial Hospital
		Clinical Trials Office - Sarasota Memorial Hospital	Ph:  941-917-2225
	West Palm Beach
	Palm Beach Cancer Institute - West Palm Beach
		Daniel Spitz	Ph:  561-366-4117
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 Chicago Cancer Research Center
		Clinical Trials Office - University of Chicago Cancer Research Center	Ph:  773-834-7424
	University of Illinois Cancer Center
		Clinical Trial Office - University of Illinois Cancer Center	Ph:  312-355-3046
	Hinsdale
	Hinsdale Hematology Oncology Associates
		Sudarshan Sharma, MD	Ph:  630-856-6757
	Springfield
	Regional Cancer Center at Memorial Medical Center
		Clinical Trials Office - Regional Cancer Center at Memorial Medical Center	Ph:  217-788-4233
Indiana
	Indianapolis
	Gynecologic Oncology of Indiana
		David Moore	Ph:  317-851-2555
	St. Vincent Indianapolis Hospital
		Clinical Trials Office - St. Vincent Indianapolis Hospital	Ph:  317-338-2194
Iowa
	Iowa City
	Holden Comprehensive Cancer Center at University of Iowa
		Cancer Information Service	Ph:  800-237-1225
Kansas
	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
Kentucky
	Lexington
	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
	New Orleans
	Ochsner Cancer Institute at Ochsner Clinic Foundation
		Richard Kline, MD	Ph:  504-842-4165
	Shreveport
	Christus Schumpert Cancer Treatment Center
		Clinical Trials Office - Christus Schumpert Cancer Treatment Center	Ph:  318-681-4763
Maryland
	Baltimore
	Greater Baltimore Medical Center Cancer Center
		Clinical Trials Office - Greater Baltimore Medical Center Cancer Center	Ph:  443-849-3706
Massachusetts
	Springfield
	Baystate Regional Cancer Program at D'Amour Center for Cancer Care
		Wilson Mertens	Ph:  413-794-9338
Michigan
	Ann Arbor
	University of Michigan Comprehensive Cancer Center
		Clinical Trials Office - University of Michigan Comprehensive Cancer Center	Ph:  800-865-1125
	Detroit
	Barbara Ann Karmanos Cancer Institute
		Clinical Trials Office - Barbara Ann Karmanos Cancer Institute	Ph:  313-576-9363
	Grand Rapids
	Butterworth Hospital at Spectrum Health
		Marianne Lange, MD	Ph:  616-977-6243
	CCOP - Grand Rapids
		Marianne Lange, MD	Ph:  616-977-6243
	Gynecologic Oncology of West Michigan
		Gordon Downey, MD	Ph:  616-957-3398
	Royal Oak
	William Beaumont Hospital - Royal Oak Campus
		Clinical Trials Office - William Beaumont Hospital - Royal Oak Campus	Ph:  248-551-7695
	Traverse City
	Munson Medical Center
		Marianne Lange, MD	Ph:  616-977-6243
Minnesota
	Minneapolis
	Masonic Cancer Center at University of Minnesota
		Clinical Trials Office - Masonic Cancer Center at University of Minnesota	Ph:  612-624-2620
	Rochester
	Mayo Clinic Cancer Center
		Clinical Trials Office - All Mayo Clinic Locations	Ph:  507-538-7623
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
	Kansas City
	CCOP - Kansas City
		Rakesh Gaur, MD	Ph:  816-823-0555
	Saint Louis
	Saint Louis University Cancer Center
		Clinical Trials Office - Saint Louis University Cancer Center	Ph:  314-977-4440
	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
	St. John's Regional Health Center
		Robert Carolla	Ph:  417-820-2000
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
	Reno
	Renown Institute for Cancer at Renown Regional Medical Center
		Peter Lim	Ph:  775-982-5050 866-559-0558
New Jersey
	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
	Fox Chase Virtua Health Cancer Program at Virtua West Jersey
		Howard Saul, DO	Ph:  856-673-0015
New Mexico
	Albuquerque
	University of New Mexico Cancer Center
		Clinical Trials Office - University of New Mexico Cancer Center	Ph:  505-272-6972
New York
	Albany
	Women's Cancer Care Associates
		Thomas Morrissey	Ph:  518-458-1390
	Brightwaters
	Schwartz Gynecologic Oncology
		Benjamin Schwartz	Ph:  631-376-0055
	Brooklyn
	SUNY Downstate Medical Center
		Ovadia Abulafia, MD	Ph:  718-270-2152
	Buffalo
	Roswell Park Cancer Institute
		Clinical Trials Office - Roswell Park Cancer Institute	Ph:  877-275-7724
	Jamaica
	Queens Cancer Center of Queens Hospital
		Natalia Calderon	Ph:  718-883-4031
	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
	New Hyde Park
	Long Island Jewish Medical Center
		Veena John	Ph:  718-470-7000 800-371-7111
	New York
	Mount Sinai Medical Center
		Monica Hayes	Ph:  212-241-6500
	NYU Cancer Institute at New York University Medical Center
		Stephanie Blank, MD	Ph:  212-263-2668
	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
	Chapel Hill
	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
		Clinical Trials Office - Lineberger Comprehensive Cancer Center	Ph:  877-668-0683; 919-966-4432
	Charlotte
	Blumenthal Cancer Center at Carolinas Medical Center
		Clinical Trials Office - Blumenthal Cancer Center at Carolinas Medical Center	Ph:  704-355-2884
	Presbyterian Cancer Center at Presbyterian Hospital
		Clinical Trials Office - Presbyterian Cancer Center at Presbyterian Hospital	Ph:  704-384-5369
	Durham
	Duke Comprehensive Cancer Center
		Clinical Trials Office - Duke Comprehensive Cancer Center	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
	Greenville
	Gynecologic Oncology Network
		Howard Homesley, MD	Ph:  252-756-5388
	Wilmington
	Zimmer Cancer Center at New Hanover Regional Medical Center
		Walter Gajewski, MD	Ph:  910-342-3000
Ohio
	Akron
	McDowell Cancer Center at Akron General Medical Center
		Eric Jenison, MD	Ph:  330-344-6041
	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
	Cleveland Clinic Cancer Center at Fairview Hospital
		Clinical Trials Office - Cleveland Clinic Cancer Center at Fairview Hospital	Ph:  216-476-9362
	Cleveland Clinic Taussig Cancer Center
		Clinical Trials Office - Cleveland Clinic Taussig Cancer Center	Ph:  866-223-8100
	MetroHealth Cancer Care Center at MetroHealth Medical Center
		Peter Rose, MD	Ph:  216-444-1712
	Columbus
	Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
		Ohio State University Cancer Clinical Trial Matching Service	Ph:  866-627-7616
			Email: osu@emergingmed.com
	Mount Carmel Health - West Hospital
		Luis Vaccarello, MD	Ph:  614-383-6000
	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
	Mayfield Heights
	Hillcrest Cancer Center at Hillcrest Hospital
		Peter Rose, MD	Ph:  216-444-1712
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
	Knight Cancer Institute at Oregon Health and Science University
		Clinical Trials Office - Knight Cancer Institute at Oregon Health and Science University	Ph:  503-494-1080
			Email: trials@ohsu.edu
	Northwest Cancer Specialists at Rose Quarter Cancer Center
		William Winter, III	Ph:  503-228-6509
	Williamette Gynecologic Oncology PC
		Paul Kucera, MD	Ph:  503-561-5294
Pennsylvania
	Abington
	Rosenfeld Cancer Center at Abington Memorial Hospital
		Clinical Trials Office - Rosenfeld Cancer Center at Abington Memorial Hospital	Ph:  215-481-2402
	Hershey
	Penn State Cancer Institute at Milton S. Hershey Medical Center
		Clinical Trials Office - Penn State 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
	Joan Karnell Cancer Center at Pennsylvania Hospital
		Patricia Ford, MD	Ph:  215-829-6088
	Reading
	McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
		Clinical Trials Office - McGlinn Family Regional Cancer Center	Ph:  610-988-9323
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
	Charleston
	Hollings Cancer Center at Medical University of South Carolina
		Clinical Trials Office - Hollings Cancer Center at Medical University of South Carolina	Ph:  843-792-9321
	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
		Samir Abu-Ghazaleh, MD	Ph:  605-331-3898
Tennessee
	Chattanooga
	Chattanooga's Program in Women's Oncology
		Stephen DePasquale	Ph:  423-266-3636
	Knoxville
	Hall and Martin, M.Ds., PC
		David Martin	Ph:  865-971-4992
	Memphis
	Baptist Centers for Cancer Care
		Clinical Trials Office - Baptist Centers for Cancer Care	Ph:  901-226-3077
	Nashville
	Vanderbilt-Ingram Cancer Center
		Clinical Trials Office - Vanderbilt-Ingram Cancer Center	Ph:  1-800-811-8480;
Texas
	Amarillo
	Harrington Cancer Center
		Clinical Trials Officec - Harrington Cancer Center	Ph:  806-359-4673
			Email: ryokubaitis@harringtoncc.org
	Galveston
	University of Texas Medical Branch
		Clinical Trials Office - University of Texas Medical Branch	Ph:  409-772-1950
	Houston
	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
	Charlottesville
	University of Virginia Cancer Center
		Susan Modesitt	Ph:  434-924-9333 800-223-9173
	Hampton
	Virginia Oncology Associates - Hampton
		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
	Roanoke
	Carilion Gynecologic Oncology Associates
		Natalie Gould	Ph:  540-345-8574 800-422-8482
Washington
	Seattle
	University Cancer Center at University of Washington Medical Center
		Clinical Trials Office - University Cancer Center at University of Washington Medical Center	Ph:  206-616-8289
Wisconsin
	Green Bay
	St. Vincent Hospital Regional Cancer Center
		Clinical Trials Office - St. Vincent Hospital Regional Cancer Center	Ph:  920-433-8889
	La Crosse
	Gundersen Lutheran Center for Cancer and Blood
		Clinical Trials Office - Gundersen Lutheran Cancer Center	Ph:  608-775-2385
			Email: cancerctr@gundluth.org
	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
	Marshfield
	Marshfield Clinic - Marshfield Center
		Clinical Trials Office - Marshfield Clinic - Marshfield Center	Ph:  800-782-1581 ext. 94457
	Milwaukee
	Columbia-Saint Mary's Cancer Care Center
		Clinical Trials Office - Columbia-St. Mary's Cancer Care Center	Ph:  414-326-1739
	Medical Consultants, Limited
		Peter Johnson, MD(Contact information may not be current)	Ph:  262-549-6662
	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
	Slinger
	Vince Lombard Cancer Clinic at Aurora Health Center - Slinger
		Peter Johnson, MD(Contact information may not be current)	Ph:  262-549-6662
	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 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		2009-07-03
NCI Grant/Contract Number		CA27469

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