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Home > "G" Clinical Trials Conditions > Gemcitabine Plus Cisplatin in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer That Is Recurrent or Has Not Responded to Platinum-based Chemotherapy  Gemcitabine Plus Cisplatin in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer That Is Recurrent or Has Not Responded to Platinum-based Chemotherapy
Gemcitabine Plus Cisplatin in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer That Is Recurrent or Has Not Responded to Platinum-based Chemotherapy
For Condition: peritoneal cavity cancer,recurrent ovarian epithelial cancer
Status: No longer recruiting
Sponsor(s): Gynecologic Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of gemcitabine plus cisplatin in treating patients who have primary ovarian epithelial cancer or primary peritoneal cancer that is recurrent or has not responded to platinum-based chemotherapy.
Details: OBJECTIVES: - Determine the anti-tumor activity of gemcitabine and cisplatin in patients with recurrent or refractory platinum-resistant ovarian epithelial cancer or primary peritoneal carcinoma who have failed on higher priority treatment protocols. - Determine the nature and degree of toxicity of this regimen in this patient population. - Correlate ex vivo drug sensitivity and resistance with clinical response to this regimen in these patients. - Correlate molecular markers of drug responsiveness and cellular apoptosis with ex vivo measures of drug resistance in these patients. OUTLINE: This is a multicenter study. Patients receive cisplatin IV over 1 hour followed by gemcitabine IV over 1 hour on days 1 and 8. Courses repeat every 4 weeks in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 5-14 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed primary ovarian epithelial cancer or primary peritoneal carcinoma - Recurrent or persistent disease - Bidimensionally measurable disease by physical examination or medical imaging techniques - Sonography is acceptable if lesions are clearly defined on initial examination and bidimensionally measurable - Ascites and pleural effusions are not considered measurable disease - Must not be eligible for a higher priority Gynecologic Oncology Group protocol - Must have received one, and only one, 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 - If no prior paclitaxel, a second regimen containing paclitaxel allowed - Platinum-resistant or refractory (i.e., treatment-free interval after platinum-based therapy of less than 6 months or progressed during platinum-based therapy) PATIENT CHARACTERISTICS: Age: - Not specified Performance status: - GOG 0-2 Life expectancy: - Not specified Hematopoietic: - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 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 Other: - Not pregnant - Negative pregnancy test - Fertile patients must use effective contraception - No active infection requiring antibiotics - No other malignancy within the past 5 years except nonmelanoma skin cancer - Sensory and motor neuropathy no greater than grade 1 PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 3 weeks since prior biologic or immunologic therapy for ovarian or peritoneal cancer Chemotherapy: - See Disease Characteristics - No other prior cytotoxic chemotherapy for recurrent or persistent disease, including retreatment with initial chemotherapy regimens - No prior gemcitabine - At least 3 weeks since prior chemotherapy for ovarian or peritoneal cancer and recovered Endocrine therapy: - At least 1 week since prior hormonal therapy for ovarian or peritoneal cancer - Concurrent continuation of hormonal replacement therapy allowed Radiotherapy: - At least 3 weeks since prior radiotherapy for ovarian or peritoneal cancer and recovered - No prior radiotherapy to only site of measurable disease - No prior radiotherapy to more than 25% of bone marrow Surgery: - See Disease Characteristics - At least 3 weeks since prior surgery for ovarian or peritoneal cancer and recovered Other: - At least 3 weeks since other prior therapy for ovarian or peritoneal cancer - No prior cancer treatment that would preclude study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
CherylBrewer, Study Chair, University of Illinois College of Medicine at Peoria
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
United States
Community Hospital of Los Gatos
Los Gatos, California, 95032
United States
CCOP - M.D. Anderson Research Base
Houston, Texas, 77030-4009
United States
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
United States
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, 73190
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
United States
Brookview Research, Inc.
Nashville, Tennessee, 37203
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1065
United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104-4283
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289
United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001-3788
United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497
United States
Ireland Cancer Center
Cleveland, Ohio, 44106
United States
Cooper Hospital/University Medical Center
Camden, New Jersey, 08103-1489
United States
Simmons Cancer Center - Dallas
Dallas, Texas, 75390-9032
United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-6188
United States
Tuft-New England Medical Center
Boston, Massachusetts, 02111
United States
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, 60612-3864
United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203
United States
Norwegian Radium Hospital
Oslo, , N-0310
Norway
University of Texas Medical Branch
Galveston, Texas, 77555-0587
United States
State University of New York Health Science Center at Brooklyn
Brooklyn, New York, 11203
United States
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, 20892-1182
United States
Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242-1009
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
Ellis Fischel Cancer Center
Indianapolis, Indiana, 46285
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, 11794-8091
United States
Additional Information:
Study ID Numbers: CDR0000068041; GOG-0126L
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006028
Other Recurrent Ovarian Epithelial Cancer Studies:
1. Docetaxel in Treating Patients With Recurrent or Refractory Ovarian or Primary Peritoneal Cancer
2. Cetuximab, Paclitaxel, and Carboplatin in Treating Patients With Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer
3. Nitrocamptothecin in Treating Patients With Recurrent or Metastatic Ovarian Epithelial or Primary Peritoneal Cancer
4. Bevacizumab in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
5. Cisplatin Plus Irinotecan in Treating Patients With Ovarian, Fallopian Tube, or Peritoneal Cancer
Related Studies:
Other recurrent ovarian epithelial cancer Clinical Trials
Other North Carolina Clinical Trials
Other Chapel Hill Clinical Trials
Gemcitabine Plus Cisplatin in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer That Is Recurrent or Has Not Responded to Platinum-based Chemotherapy
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