Oxaliplatin in Treating Patients With Recurrent or Refractory Ovarian Epithelial Cancer or Primary Peritoneal Cancer That Has Not Responded to Platinum- Based Chemotherapy

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00005836
First received: June 2, 2000
Last updated: June 20, 2013
Last verified: March 2003
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of oxaliplatin in treating patients who have recurrent or refractory ovarian epithelial cancer or primary peritoneal cancer that has not responded to platinum-based chemotherapy.


Condition Intervention Phase
Ovarian Cancer
Primary Peritoneal Cavity Cancer
Drug: oxaliplatin
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase II Evaluation of Oxaliplatin in Recurrent, Platinum Resistant and Refractory Ovarian Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: February 2000
Study Completion Date: July 2004
Detailed Description:

OBJECTIVES: I. Determine the antitumor activity of oxaliplatin by measuring response rate in patients with recurrent or refractory, platinum resistant ovarian epithelial or primary peritoneal carcinoma who have failed on higher priority treatment protocols. II. Determine the nature and degree of toxicity of this drug in this patient population.

OUTLINE: Patients receive oxaliplatin IV over 2 hours. Treatment continues every 21 days for a maximum of 9 courses in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 22-60 patients will be accrued for this study within 12-14 months.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically confirmed recurrent or refractory ovarian epithelial or primary peritoneal carcinoma Bidimensionally measurable disease Ascites and pleural effusions are not considered measurable disease Sonography acceptable provided lesions are clearly defined on initial examination and bidimensionally measurable Must have had 1 prior platinum based chemotherapy regimen containing carboplatin, cisplatin, or another organoplatinum compound for management of primary disease Initial treatment may include high dose therapy, consolidation, or extended therapy administered after surgical or nonsurgical assessment No additional cytotoxic chemotherapy for management of recurrent or persistent disease, including retreatment with initial chemotherapy regimens Must be considered platinum resistant or refractory Treatment free interval of less than 6 months following platinum or progression during platinum based therapy No known brain metastases Must not be eligible for a higher priority GOG protocol

PATIENT CHARACTERISTICS: Age: Not specified Performance status: GOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least lower limit of normal Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT no greater than 2.5 times ULN Alkaline phosphatase no greater than 2.5 times ULN Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Other: Not pregnant or nursing Fertile patients must use effective contraception No active infection requiring antibiotics No evidence of preexisting peripheral sensory neuropathy greater than grade 1, including residual neuropathy attributed to prior chemotherapy and other chronic conditions (e.g., diabetes, venous stasis, and carpal tunnel syndrome) No history of allergy to platinum compounds or to antiemetics appropriate for administration in conjunction with protocol directed chemotherapy No other uncontrolled concurrent illness (e.g., ongoing or active infection) No other malignancy within the past 5 years except nonmelanoma skin cancer and no other prior malignancy whose prior cancer treatment contraindicates this protocol therapy

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior biologic therapy At least 3 weeks since prior immunotherapy No concurrent colony stimulating factors (CSFs) during first course of therapy At least 24 hours since prior CSFs during subsequent courses of therapy Chemotherapy: See Disease Characteristics No prior oxaliplatin No more than 1 prior chemotherapy regimen If initial therapy did not include paclitaxel, a second regimen including paclitaxel is allowed At least 3 weeks since prior chemotherapy and recovered Endocrine therapy: At least 1 week since prior hormonal therapy directed at malignant tumor Concurrent continuation of hormone replacement therapy allowed Radiotherapy: At least 3 weeks since prior radiotherapy and recovered No prior radiotherapy to sites of measurable disease used on this trial No prior radiotherapy to greater than 25% of bone marrow Surgery: At least 3 weeks since prior surgery and recovered Other: No other concurrent investigational agents No concurrent antiretroviral therapy (HAART)

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005836

  Hide Study Locations
Locations
United States, Alabama
University of Alabama Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294
United States, Arizona
CCOP - Greater Phoenix
Phoenix, Arizona, United States, 85006-2726
United States, California
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033-0800
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Women's Cancer Center
Palo Alto, California, United States, 94304
United States, Colorado
University of Colorado Cancer Center
Denver, Colorado, United States, 80262
United States, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307-5000
Vincent T. Lombardi Cancer Research Center, Georgetown University
Washington, District of Columbia, United States, 20007
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
United States, Georgia
Emory University Hospital - Atlanta
Atlanta, Georgia, United States, 30322
United States, Hawaii
MBCCOP - Hawaii
Honolulu, Hawaii, United States, 96813
United States, Illinois
MBCCOP - University of Illinois at Chicago
Chicago, Illinois, United States, 60612-7323
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, United States, 60612
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637
CCOP - Evanston
Evanston, Illinois, United States, 60201
CCOP - Central Illinois
Springfield, Illinois, United States, 62526
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202-5265
United States, Iowa
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States, 10309-1016
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Kentucky
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, United States, 40536-0084
United States, Maryland
Johns Hopkins Oncology Center
Baltimore, Maryland, United States, 21287
Medicine Branch
Bethesda, Maryland, United States, 20892
Radiation Oncology Branch
Bethesda, Maryland, United States, 20892
United States, Massachusetts
Tufts University School of Medicine
Boston, Massachusetts, United States, 02111
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States, 01655
United States, Michigan
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, United States, 48106
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, Minnesota
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States, 55455
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216-4505
Keesler Medical Center - Keesler AFB
Keesler AFB, Mississippi, United States, 39534-2576
United States, Missouri
Ellis Fischel Cancer Center
Columbia, Missouri, United States, 65203
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States, 65807
United States, Montana
CCOP - Montana Cancer Consortium
Billings, Montana, United States, 59101
United States, Nebraska
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States, 68131
United States, Nevada
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
United States, New Jersey
Cooper Hospital/University Medical Center
Camden, New Jersey, United States, 08103
United States, New York
Cancer Center of Albany Medical Center
Albany, New York, United States, 12208
State University of New York Health Science Center at Brooklyn
Brooklyn, New York, United States, 11203
North Shore University Hospital
Manhasset, New York, United States, 11030
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
University of Rochester Cancer Center
Rochester, New York, United States, 14642
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, United States, 11790-9832
United States, North Carolina
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States, 27599-7295
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157-1082
Brookview Research, Inc.
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Barrett Cancer Center, The University Hospital
Cincinnati, Ohio, United States, 45219
Cleveland Clinic Cancer Center
Cleveland, Ohio, United States, 44195
Ireland Cancer Center
Cleveland, Ohio, United States, 44106-5065
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States, 43210
United States, Oklahoma
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, United States, 73190
CCOP - St. Francis Hospital/Natalie Warren Bryant Cancer Center
Tulsa, Oklahoma, United States, 74136
United States, Oregon
CCOP - Columbia River Program
Portland, Oregon, United States, 97213
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States, 19107
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States, 19104
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States, 19107
CCOP - MainLine Health
Wynnewood, Pennsylvania, United States, 19096
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425-0721
CCOP - Greenville
Greenville, South Carolina, United States, 29615
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
United States, Tennessee
CCOP - Baptist Cancer Institute
Memphis, Tennessee, United States, 38117
United States, Texas
Simmons Cancer Center - Dallas
Dallas, Texas, United States, 75235-9154
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030
CCOP - Scott and White Hospital
Temple, Texas, United States, 76508
United States, Virginia
Cancer Center, University of Virginia HSC
Charlottesville, Virginia, United States, 22908
United States, Washington
University of Washington Medical Center
Seattle, Washington, United States, 98195-6043
Tacoma General Hospital
Tacoma, Washington, United States, 98405
Canada, Ontario
NCIC-Clinical Trials Group
Kingston, Ontario, Canada, K7L 3N6
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: Paula M. Fracasso, MD, PhD Washington University Siteman Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00005836     History of Changes
Other Study ID Numbers: CDR0000067851, GOG-126K
Study First Received: June 2, 2000
Last Updated: June 20, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent ovarian epithelial cancer
primary peritoneal cavity cancer

Additional relevant MeSH terms:
Peritoneal Neoplasms
Ovarian Neoplasms
Abdominal Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Oxaliplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014