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Clinical Trials (PDQ®)

Elesclomol Sodium and Paclitaxel in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IITreatmentActive18 and overNCI, OtherGOG-0260
NCI-2011-01919, CDR0000641202, U10CA027469, NCT00888615

Trial Description

Summary

This phase II trial is studying the side effects of giving elesclomol sodium together with paclitaxel and to see how well it works in treating patients with recurrent or persistent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer. Drugs used in chemotherapy, such as elesclomol sodium and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving elesclomol together with paclitaxel may kill more tumor cells.

Further Study Information

PRIMARY OBJECTIVES:

I. To estimate the antitumor activity of elesclomol (elesclomol sodium) and paclitaxel in patients with persistent or recurrent ovarian, fallopian tube, or primary peritoneal cancer primarily through the frequency of objective tumor responses.

II. To determine the nature and degree of toxicity of elesclomol and paclitaxel in these patients.

SECONDARY OBJECTIVES:

I. To estimate the progression-free survival and overall survival of patients treated with elesclomol and paclitaxel.

OUTLINE: This is a multicenter study.

Patients receive elesclomol sodium intravenously (IV) over 1 hour and paclitaxel IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

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

Eligibility Criteria

Inclusion Criteria:

  • Patients must have recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal carcinoma; histologic documentation of the original primary tumor is required via the pathology report
  • Patients with the following histologic epithelial cell types are eligible: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's Tumor, or adenocarcinoma not otherwise specified (N.O.S.)
  • All patients must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1; measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded); each lesion must be >= 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI) or caliper measurement by clinical exam; or >= 20 mm when measured by chest x-ray; lymph nodes must be >= 15 mm in short axis when measured by CT or MRI
  • Patients must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST 1.1; tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
  • Patients must not be eligible for a higher priority Gynecologic Oncology Group (GOG) protocol, if one exists; in general, this would refer to any active GOG Phase III protocol for the same patient population
  • Patients must have a GOG performance status of 0, 1, or 2
  • Patients must have baseline lactate dehydrogenase (LDH) levels =< 0.8 times upper limit of normal (ULN)
  • Recovered from prior surgery, radiotherapy, or chemotherapy
  • Patients should be free of active infection requiring antibiotics (with the exception of uncomplicated UTI)
  • Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration
  • Any other prior therapy directed at the malignant tumor, including biological and immunologic agents, must be discontinued at least three weeks prior to registration
  • Prior therapy
  • Patients must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound; this initial treatment may have included intraperitoneal therapy, high-dose therapy, consolidation, non-cytotoxic agents or extended therapy administered after surgical or non-surgical assessment
  • Patients must have NOT received any additional cytotoxic chemotherapy for management of recurrent or persistent disease, including retreatment with initial chemotherapy regimens; (Note: optimal evaluation of the safety and efficacy of new chemotherapy regimens is best performed in patients with minimal prior therapy; non-investigational therapy, such as retreatment with platinum and/or paclitaxel, is non-curative in the setting of recurrent disease, and can generally be safely administered to patients following participation in a Phase II trial)
  • Patients are allowed to receive, but are not required to receive, one additional non-cytotoxic regimen for management of recurrent or persistent disease according to the following definition:
  • Non-cytotoxic (biologic or cytostatic) agents include (but are not limited to) hormones, monoclonal antibodies, cytokines, and small-molecule inhibitors of signal transduction
  • Patients must be considered platinum resistant or refractory according to standard GOG criteria, i.e., have had a treatment-free interval following platinum of less than 6 months, or have progressed during platinum-based therapy
  • Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl
  • Platelets greater than or equal to 100,000/mcl
  • Creatinine less than or equal to 1.5 x institutional upper limit normal (ULN)
  • Bilirubin less than or equal to 1.5 x ULN
  • Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) less than or equal to 3 x ULN
  • Alkaline phosphatase less than or equal to 2.5 x ULN
  • Neurologic function: no neuropathy (sensory and motor) less than or equal to Common Terminology Criteria for Adverse Events (CTCAE) grade 1
  • Patients must have signed an approved informed consent and authorization permitting release of personal health information
  • Patients must meet pre-entry requirements
  • Patients of childbearing potential must have a negative serum pregnancy test prior to study entry and be practicing an effective form of contraception
  • Cautions and prohibited medications/treatments
  • Since elesclomol is a substrate for cytochrome P450 2C9 (CYP2C9), cytochrome P450 2D6 (CYP2D6), CYP2C19, and cytochrome P450 3A4 (CYP3A4) and an inducer of CYP3A4, CYP1A2, CYP2A6, and cytochrome P450 2E1 (CY2E1), it is recommended that the following be used with caution: sensitive substrates of CYP3A4, CYP1A2, and CY2E1, and strong inhibitors and inducers of CYP2C9, CYP2D6, CYP2C19, and CYP3A4

Exclusion Criteria:

  • Patients who have had prior therapy with elesclomol or prior second-line cytotoxic chemotherapy
  • Patients who have received radiation to more than 25% of marrow-bearing areas
  • Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies are excluded if there is any evidence of other malignancy being present within the last three years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy
  • Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis OTHER THAN for the treatment of ovarian, fallopian tube, or primary peritoneal cancer are excluded; prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease
  • Patients who have received prior chemotherapy for any abdominal or pelvic tumor OTHER THAN for the treatment of ovarian, fallopian tube, or primary peritoneal cancer are excluded; patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease
  • Patients who are pregnant or breastfeeding

Trial Contact Information

Trial Lead Organizations/Sponsors

Gynecologic Oncology Group

National Cancer Institute

Bradley MonkPrincipal Investigator

Trial Sites

U.S.A.
Arizona
  Phoenix
 St. Joseph's Hospital and Medical Center
 Bradley J. Monk Ph: 877-602-4111
California
  Concord
 Cancer Care Center at John Muir Health - Concord Campus
 Babak Edraki Ph: 925-674-2580
  La Jolla
 Rebecca and John Moores UCSD Cancer Center
 Bradley J. Monk
Colorado
  Aurora
 University of Colorado Cancer Center at UC Health Sciences Center
 Susan Davidson Ph: 720-848-0650
Connecticut
  Farmington
 Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
 Angela S Kueck Ph: 800-579-7822
  Hartford
 Helen and Harry Gray Cancer Center at Hartford Hospital
 Mark M. Hoffman Ph: 518-926-6700
 Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
 Philip J. Stella Ph: 734-712-4673
  New Britain
 George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
 Mark M. Hoffman Ph: 518-926-6700
Georgia
  Atlanta
 Piedmont Hospital
 John Warren McBroom
  Email: ORS@piedmont.org
  Savannah
 Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
 William Edward Richards Ph: 800-622-6877
Idaho
  Boise
 Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
 Philip J. Stella Ph: 734-712-4673
Illinois
  Chicago
 Rush Cancer Institute at Rush University Medical Center
 Jacob Rotmensch Ph: 312-942-5498
  Email: clinical_trials@rush.edu
 University of Chicago Cancer Research Center
 Meaghan E Tenney Ph: 773-834-7424
  Decatur
 Cancer Care Center of Decatur
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
 Decatur Memorial Hospital Cancer Care Institute
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
  Effingham
 Crossroads Cancer Center
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
  Hinsdale
 Gynecologic Oncology
 Sudarshan K. Sharma Ph: 630-856-6757
  New Lennox
 Silver Cross Hospital
 Meaghan E Tenney Ph: 773-834-7424
Indiana
  Indianapolis
 Indiana University Melvin and Bren Simon Cancer Center
 Jeanne M Schilder Ph: 317-274-2552
 St. Vincent Oncology Center
 Gregory P. Sutton Ph: 317-338-2194
Iowa
  Ames
 McFarland Clinic, PC
 Joseph James Merchant Ph: 515-239-2621
Kansas
  Chanute
 Cancer Center of Kansas, PA - Chanute
 Shaker R. Dakhil Ph: 316-262-4467
  Dodge City
 Cancer Center of Kansas, PA - Dodge City
 Shaker R. Dakhil Ph: 316-262-4467
  El Dorado
 Cancer Center of Kansas, PA - El Dorado
 Shaker R. Dakhil Ph: 316-262-4467
  Fort Scott
 Cancer Center of Kansas - Fort Scott
 Shaker R. Dakhil Ph: 316-262-4467
  Independence
 Cancer Center of Kansas-Independence
 Shaker R. Dakhil Ph: 316-262-4467
  Kingman
 Cancer Center of Kansas, PA - Kingman
 Shaker R. Dakhil Ph: 316-262-4467
  Liberal
 Cancer Center of Kansas, PA - Liberal
 Shaker R. Dakhil Ph: 316-262-4467
  Newton
 Cancer Center of Kansas, PA - Newton
 Shaker R. Dakhil Ph: 316-262-4467
  Parsons
 Cancer Center of Kansas, PA - Parsons
 Shaker R. Dakhil Ph: 316-262-4467
  Pratt
 Cancer Center of Kansas, PA - Pratt
 Shaker R. Dakhil Ph: 316-262-4467
  Salina
 Cancer Center of Kansas, PA - Salina
 Shaker R. Dakhil Ph: 316-262-4467
  Wellington
 Cancer Center of Kansas, PA - Wellington
 Shaker R. Dakhil Ph: 316-262-4467
  Wichita
 Associates in Women's Health, PA - North Hillside
 Shaker R. Dakhil Ph: 316-262-4467
 Cancer Center of Kansas, PA - Medical Arts Tower
 Shaker R. Dakhil Ph: 316-262-4467
 Cancer Center of Kansas, PA - Wichita
 Shaker R. Dakhil Ph: 316-262-4467
 Via Christi Cancer Center at Via Christi Regional Medical Center
 Shaker R. Dakhil Ph: 316-262-4467
  Winfield
 Cancer Center of Kansas, PA - Winfield
 Shaker R. Dakhil Ph: 316-262-4467
Kentucky
  Lexington
 University of Kentucky Chandler Medical Center
 Frederick Ueland Ph: 859-257-3379
Louisiana
  Baton Rouge
 Woman's Hospital
 Giles Fort Ph: 225-215-1353
  Email: clinicalreserach@marybird.com
Maryland
  Baltimore
 Greater Baltimore Medical Center Cancer Center
 Paul Celano Ph: 443-849-3706
Michigan
  Ann Arbor
 Saint Joseph Mercy Cancer Center
 Philip J. Stella Ph: 734-712-4673
  Flint
 Hurley Medical Center
 Philip J. Stella Ph: 734-712-4673
  Kalamazoo
 Borgess Medical Center
 Raymond Sterling Lord Ph: 269-373-7458
 Bronson Methodist Hospital
 Raymond Sterling Lord Ph: 269-373-7458
 West Michigan Cancer Center
 Raymond Sterling Lord Ph: 269-373-7458
  Pontiac
 St. Joseph Mercy Oakland
 Philip J. Stella Ph: 734-712-4673
  Port Huron
 Mercy Regional Cancer Center at Mercy Hospital
 Philip J. Stella Ph: 734-712-4673
Mississippi
  Jackson
 University of Mississippi Cancer Clinic
 James Tate Thigpen Ph: 601-815-6700
Missouri
  Cape Girardeau
 Saint Francis Medical Center
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
  Saint Louis
 Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
 David Gardner Mutch Ph: 800-600-3606
  Email: info@ccadmin.wustl.edu
  Springfield
 Hulston Cancer Center at Cox Medical Center South
 Jay W Carlson Ph: 800-821-7532
 St. John's Regional Health Center
 Jay W Carlson Ph: 800-821-7532
Nevada
  Las Vegas
 Women's Cancer Center - La Canada
 Nick M. Spirtos Ph: 702-851-4672
New Jersey
  Camden
 Cancer Institute of New Jersey at Cooper University Hospital - Camden
 David P. Warshal Ph: 856-325-6757
New York
  Stony Brook
 Stony Brook University Cancer Center
 Michael L. Pearl Ph: 800-862-2215
North Carolina
  Asheboro
 Randolph Hospital
 James M Granfortuna Ph: 336-832-0821
  Burlington
 Alamance Cancer Center at Alamance Regional Medical Center
 James M Granfortuna Ph: 336-832-0821
  Charlotte
 Presbyterian Cancer Center at Presbyterian Hospital
 John M McDonald Ph: 704-384-5369
  Greensboro
 Moses Cone Regional Cancer Center at Wesley Long Community Hospital
 James M Granfortuna Ph: 336-832-0821
  Hendersonville
 Comprehensive Cancer Center at Pardee Hospital
 James E. Radford Ph: 828-696-4716
 Hendersonville Hematology and Oncology
 James E. Radford Ph: 828-696-4716
  Kernersville
 Novant Health Oncology Specialists-Kernersville
 Charles H Pippitt Ph: 336-277-8887
  Lexington
 Novant Health Oncology Specialists-Davidson County
 Charles H Pippitt Ph: 336-277-8887
  Mebane
 Cone Heath Cancer Center at Mebane
 James M Granfortuna Ph: 336-832-0821
  Mount Airy
 Novant Health Oncology Specialists-Mount Airy
 Charles H Pippitt Ph: 336-277-8887
  Reidsville
 Annie Penn Cancer Center
 James M Granfortuna Ph: 336-832-0821
  Wilkesboro
 Novant Health Oncology Specialists-Wilkesboro
 Charles H Pippitt Ph: 336-277-8887
  Winston-Salem
 Forsyth Regional Cancer Center at Forsyth Medical Center
 Charles H Pippitt Ph: 336-277-8887
 Piedmont Hematology-Oncology Associates
 Charles H Pippitt Ph: 336-277-8887
 Wake Forest University Comprehensive Cancer Center
 Samuel S. Lentz Ph: 336-713-6771
 Winston-Salem Health Care
 Charles H Pippitt Ph: 336-277-8887
Ohio
  Akron
 McDowell Cancer Center at Akron General Medical Center
 Esther H. Rehmus Ph: 330-344-6348
  Cleveland
 Cleveland Clinic Cancer Center at Fairview Hospital
 Peter Graham Rose Ph: 866-223-8100
 Cleveland Clinic Taussig Cancer Center
 Peter Graham Rose Ph: 866-223-8100
  Columbus
 Riverside Methodist Hospital Cancer Care
 J. Philip Kuebler Ph: 614-566-3275
 Zangmeister Center
 J. Philip Kuebler Ph: 614-566-3275
  Dayton
 Grandview Hospital
 Thomas J. Reid Ph: 937-298-3399
  Mayfield Heights
 Hillcrest Cancer Center at Hillcrest Hospital
 Peter Graham Rose Ph: 866-223-8100
Oklahoma
  Oklahoma City
 Oklahoma University Cancer Institute
 Robert S. Mannel Ph: 405-271-4272
  Email: julie-traylor@ouhsc.edu
  Tulsa
 Cancer Care Associates-Yale
 Robert S. Mannel Ph: 405-271-4272
  Email: julie-traylor@ouhsc.edu
Pennsylvania
  Abington
 Rosenfeld Cancer Center at Abington Memorial Hospital
 Parviz Hanjani Ph: 215-481-2402
  Bryn Mawr
 Bryn Mawr Hospital
 Albert S DeNittis Ph: 866-225-5654
  Paoli
 Cancer Center of Paoli Memorial Hospital
 Albert S DeNittis Ph: 866-225-5654
  Wynnewood
 Lankenau Cancer Center at Lankenau Hospital
 Albert S DeNittis Ph: 866-225-5654
Rhode Island
  Providence
 Women and Infants Hospital of Rhode Island
 Paul A. DiSilvestro Ph: 401-274-1122
South Dakota
  Rapid City
 Black Hills Obstetrics & Gynecology LLP
 Helen L. Frederickson Ph: 605-343-9224
 Rapid City Regional Hospital
 Helen L. Frederickson Ph: 605-343-9224
Tennessee
  Bristol
 Wellmont-Bristol Regional Medical Center
 Asheesh Shipstone Ph: 423-578-8538
  Johnson City
 Wellmont Medical Associates Oncology and Hematology-Johnson City
 Asheesh Shipstone Ph: 423-578-8538
  Kingsport
 Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
 Asheesh Shipstone Ph: 423-578-8538
 Kingsport Hematology-Oncology Associates
 Asheesh Shipstone Ph: 423-578-8538
Texas
  Houston
 Lyndon B. Johnson General Hospital
 Lois M. Ramondetta Ph: 713-792-3245
 M. D. Anderson Cancer Center at University of Texas
 Lois M. Ramondetta
  Email: lramonde@mdanderson.org
 Univeristy of Texas M.D. Anderson Cancer Center
 Lois M. Ramondetta Ph: 713-792-3245
Vermont
  Burlington
 Fletcher Allen Health Care - Medical Center Campus
 Cheung Wong Ph: 802-656-4101
Virginia
  Charlottesville
 University of Virginia Cancer Center
 Susan C Modesitt Ph: 434-243-6143
  Norton
 Southwest Virginia Regional Cancer Center at Wellmonth Health
 Asheesh Shipstone Ph: 423-578-8538
  Richmond
 Virginia Commonwealth University Massey Cancer Center
 Jori S Carter Ph: 804-628-1939
  Roanoke
 Carilion Clinic Gynecological Oncology
 Janet L. Osborne Ph: 540-985-8510
Washington
  Seattle
 Pacific Gynecology Specialists
 Benjamin E. Greer Ph: 206-616-8289
 Seattle Cancer Care Alliance
 Benjamin E. Greer Ph: 206-616-8289
 Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
 Benjamin E. Greer Ph: 206-616-8289
 Swedish Cancer Institute at Northwest Hospital & Medical Center
 Benjamin E. Greer Ph: 206-616-8289
 University Cancer Center at University of Washington Medical Center
 Benjamin E. Greer Ph: 206-616-8289
  Spokane
 Cancer Care Northwest - Spokane South
 Benjamin E. Greer Ph: 206-616-8289
  Walla Walla
 St. Mary Regional Cancer Center at St. Mary Medical Center
 Benjamin E. Greer Ph: 206-616-8289
Wisconsin
  Green Bay
 Green Bay Oncology, Limited at St. Mary's Hospital
 Jonathan E Tammela Ph: 920-433-8889
 Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
 Jonathan E Tammela Ph: 920-433-8889
 St. Vincent Hospital Regional Cancer Center
 Jonathan E Tammela Ph: 920-433-8889
  Madison
 University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
 David M Kushner Ph: 877-405-6866
  Manitowoc
 Holy Family Memorial Medical Center Cancer Care Center
 Jonathan E Tammela Ph: 920-433-8889
  Marinette
 Bay Area Cancer Care Center at Bay Area Medical Center
 Jonathan E Tammela Ph: 920-433-8889

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00888615
ClinicalTrials.gov processed this data on December 14, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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