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Oxaliplatin in Treating Patients With Recurrent or Refractory Ovarian Epithelial Cancer or Primary Peritoneal Cancer That Has Not Responded to Platinum- based Chemotherapy Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Oxaliplatin in Treating Patients With Recurrent or Refractory Ovarian Epithelial Cancer or Primary Peritoneal Cancer That Has Not Responded to Platinum- based Chemotherapy conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Oxaliplatin in Treating Patients With Recurrent or Refractory Ovarian Epithelial Cancer or Primary Peritoneal Cancer That Has Not Responded to Platinum- based Chemotherapy Clinical research trials and Oxaliplatin in Treating Patients With Recurrent or Refractory Ovarian Epithelial Cancer or Primary Peritoneal Cancer That Has Not Responded to Platinum- based Chemotherapy health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Oxaliplatin in Treating Patients With Recurrent or Refractory Ovarian Epithelial Cancer or Primary Peritoneal Cancer That Has Not Responded to Platinum- based Chemotherapy. Oxaliplatin in Treating Patients With Recurrent or Refractory Ovarian Epithelial Cancer or Primary Peritoneal Cancer That Has Not Responded to Platinum- based Chemotherapy Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Oxaliplatin in Treating Patients With Recurrent or Refractory Ovarian Epithelial Cancer or Primary Peritoneal Cancer That Has Not Responded to Platinum- based Chemotherapy clinical trial. Subjects frequently get the best healthcare possible for their Oxaliplatin in Treating Patients With Recurrent or Refractory Ovarian Epithelial Cancer or Primary Peritoneal Cancer That Has Not Responded to Platinum- based Chemotherapy condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.

Home > "O" Clinical Trials Conditions > Oxaliplatin in Treating Patients With Recurrent or Refractory Ovarian Epithelial Cancer or Primary Peritoneal Cancer That Has Not Responded to Platinum- based Chemotherapy

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



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

For Condition: recurrent ovarian epithelial cancer,peritoneal cavity cancer
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , Gynecologic Oncology Group
Synopsis: 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.
Details: 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. PROTOCOL 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:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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) --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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
PaulaFracasso,  Study Chair,  Gynecologic Oncology Group

CCOP - St. Francis Hospital/Natalie Warren Bryant Cancer Center
Tulsa,  Oklahoma,  74136
United States
 

Emory University Hospital - Atlanta
Atlanta,  Georgia,  30322
United States
 

CCOP - Columbia River Program
Portland,  Oregon,  97213
United States
 

Ireland Cancer Center
Cleveland,  Ohio,  44106-5065
United States
 

CCOP - MainLine Health
Wynnewood,  Pennsylvania,  19096
United States
 

State University of New York Health Science Center at Brooklyn
Brooklyn,  New York,  11203
United States
 

North Shore University Hospital
Manhasset,  New York,  11030
United States
 

Albert B. Chandler Medical Center, University of Kentucky
Lexington,  Kentucky,  40536-0084
United States
 

Johns Hopkins Oncology Center
Baltimore,  Maryland,  21287
United States
 

CCOP - Evanston
Evanston,  Illinois,  60201
United States
 

Indiana University Cancer Center
Indianapolis,  Indiana,  46202-5265
United States
 

Brookview Research, Inc.
Winston Salem,  North Carolina,  27103
United States
 

CCOP - Greenville
Greenville,  South Carolina,  29615
United States
 

Simmons Cancer Center - Dallas
Dallas,  Texas,  75235-9154
United States
 

NCIC-Clinical Trials Group
Kingston,  Ontario,  K7L 3N6
Canada
 

CCOP - Kansas City
Kansas City,  Missouri,  64131
United States
 

University of Mississippi Medical Center
Jackson,  Mississippi,  39216-4505
United States
 

University of Texas - MD Anderson Cancer Center
Houston,  Texas,  77030
United States
 

Cleveland Clinic Cancer Center
Cleveland,  Ohio,  44195
United States
 

Milton S. Hershey Medical Center
Hershey,  Pennsylvania,  17033
United States
 

Women's Cancer Center
Palo Alto,  California,  94304
United States
 

Rush-Presbyterian-St. Luke's Medical Center
Chicago,  Illinois,  60612
United States
 

CCOP - Ann Arbor Regional
Ann Arbor,  Michigan,  48106
United States
 

Abington Memorial Hospital
Abington,  Pennsylvania,  19001
United States
 

University of Colorado Cancer Center
Denver,  Colorado,  80262
United States
 

USC/Norris Comprehensive Cancer Center
Los Angeles,  California,  90033-0800
United States
 

CCOP - Iowa Oncology Research Association
Des Moines,  Iowa,  10309-1016
United States
 

Tufts University School of Medicine
Boston,  Massachusetts,  02111
United States
 

CCOP - Missouri Valley Cancer Consortium
Omaha,  Nebraska,  68131
United States
 

Vincent T. Lombardi Cancer Research Center, Georgetown University
Washington D.C.,  District of Columbia,  20007
United States
 

Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston Salem,  North Carolina,  27157-1082
United States
 

MBCCOP - Hawaii
Honolulu,  Hawaii,  96813
United States
 

University of Iowa Hospitals and Clinics
Iowa City,  Iowa,  52242
United States
 

CCOP - Greater Phoenix
Phoenix,  Arizona,  85006-2726
United States
 

Duke Comprehensive Cancer Center
Durham,  North Carolina,  27710
United States
 

Fox Chase Cancer Center
Philadelphia,  Pennsylvania,  19111
United States
 

Ellis Fischel Cancer Center
Columbia,  Missouri,  65203
United States
 

University of Minnesota Cancer Center
Minneapolis,  Minnesota,  55455
United States
 

Chao Family Comprehensive Cancer Center
Orange,  California,  92868
United States
 

Cooper Hospital/University Medical Center
Camden,  New Jersey,  08103
United States
 

CCOP - Upstate Carolina
Spartanburg,  South Carolina,  29303
United States
 

Radiation Oncology Branch
Bethesda,  Maryland,  20892
United States
 

University of Chicago Cancer Research Center
Chicago,  Illinois,  60637
United States
 

University of Oklahoma College of Medicine
Oklahoma City,  Oklahoma,  73190
United States
 

MBCCOP - University of Illinois at Chicago
Chicago,  Illinois,  60612-7323
United States
 

Jonsson Comprehensive Cancer Center, UCLA
Los Angeles,  California,  90095-1781
United States
 

CCOP - Montana Cancer Consortium
Billings,  Montana,  59101
United States
 

University of Pennsylvania Cancer Center
Philadelphia,  Pennsylvania,  19104
United States
 

CCOP - Baptist Cancer Institute
Memphis,  Tennessee,  38117
United States
 

Tacoma General Hospital
Tacoma,  Washington,  98405
United States
 

University of Rochester Cancer Center
Rochester,  New York,  14642
United States
 

State University of New York Health Sciences Center - Stony Brook
Stony Brook,  New York,  11790-9832
United States
 

University of Massachusetts Memorial Medical Center
Worcester,  Massachusetts,  01655
United States
 

Pennsylvania Hospital
Philadelphia,  Pennsylvania,  19107
United States
 

University of Washington Medical Center
Seattle,  Washington,  98195-6043
United States
 

CCOP - Southern Nevada Cancer Research Foundation
Las Vegas,  Nevada,  89106
United States
 

University of Alabama Comprehensive Cancer Center
Birmingham,  Alabama,  35294
United States
 

Arthur G. James Cancer Hospital - Ohio State University
Columbus,  Ohio,  43210
United States
 

H. Lee Moffitt Cancer Center and Research Institute
Tampa,  Florida,  33612
United States
 

Barbara Ann Karmanos Cancer Institute
Detroit,  Michigan,  48201
United States
 

Cancer Center, University of Virginia HSC
Charlottesville,  Virginia,  22908
United States
 

Cancer Center of Albany Medical Center
Albany,  New York,  12208
United States
 

Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia,  Pennsylvania,  19107
United States
 

Washington University School of Medicine
St. Louis,  Missouri,  63110
United States
 

Medicine Branch
Bethesda,  Maryland,  20892
United States
 

Walter Reed Army Medical Center
Washington D.C.,  District of Columbia,  20307-5000
United States
 

CCOP - Scott and White Hospital
Temple,  Texas,  76508
United States
 

Barrett Cancer Center, The University Hospital
Cincinnati,  Ohio,  45219
United States
 

Memorial Sloan-Kettering Cancer Center
New York City,  New York,  10021
United States
 

Keesler Medical Center - Keesler AFB
Keesler AFB,  Mississippi,  39534-2576
United States
 

Lineberger Comprehensive Cancer Center, UNC
Chapel Hill,  North Carolina,  27599-7295
United States
 

CCOP - Central Illinois
Springfield,  Illinois,  62526
United States
 

Medical University of South Carolina
Charleston,  South Carolina,  29425-0721
United States
 

CCOP - Cancer Research for the Ozarks
Springfield,  Missouri,  65807
United States
 


Additional Information:
Study ID Numbers:
  CDR0000067851;  GOG-126K
Study Start Date: February 2000
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005836

Other Peritoneal Cavity Cancer Studies:
1. Lurtotecan Liposome in Treating Patients With Advanced or Recurrent Ovarian Epithelial Cancer

2. Quality-of-Life Assessment in Patients With Ovarian Cancer

3. Aminocamptothecin in Treating Patients With Recurrent or Refractory Ovarian Epithelial Cancer or Primary Cancer of the Peritoneum

4. Tamoxifen Compared With Thalidomide in Treating Women With Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

5. Radiolabeled Monoclonal Antibody in Treating Patients With Advanced Ovarian Epithelial Cancer

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

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