Capecitabine in Treating Patients With Recurrent Ovarian Epithelial or Primary Peritoneal Cavity Cancer
NCT ID: NCT00006812
Last Updated: 2013-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
INTERVENTIONAL
2001-03-31
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of capecitabine in treating patients who have recurrent ovarian epithelial or primary peritoneal cavity cancer.
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Detailed Description
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* Determine the antitumor activity of capecitabine in patients with recurrent, platinum-sensitive ovarian epithelial or primary peritoneal cavity cancer.
* Determine the nature and degree of toxicity of this drug in this patient population.
OUTLINE: This is a multicenter study.
Patients receive oral capecitabine twice daily for 14 days. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
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 6-12 months.
Conditions
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Study Design
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TREATMENT
Interventions
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capecitabine
Eligibility Criteria
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Inclusion Criteria
Age:
* Any age
Performance status:
* GOG 0-2
Life expectancy:
* Not specified
Hematopoietic:
* Absolute neutrophil count at least 1,500/mm\^3
* 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 clearance at least 50 mL/min
Other:
* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception
* No neuropathy (sensory and motor) greater than grade 1
* No other malignancy within the past 5 years except nonmelanoma skin cancer
* No concurrent active infection requiring antibiotics
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 3 weeks since prior biologic or immunologic therapy
* No concurrent prophylactic filgrastim (G-CSF)
Chemotherapy:
* See Disease Characteristics
* If no prior therapy with paclitaxel, a second regimen including paclitaxel allowed
* No prior capecitabine or fluorouracil
* No prior chemotherapy for recurrent or persistent disease, including pretreatment with initial chemotherapy regimens
* Recovered from prior chemotherapy
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 site(s) of measurable disease
* No prior radiotherapy to more than 25% of bone marrow
Surgery:
* Recovered from prior surgery
Other:
* No prior cancer treatment that would preclude study therapy
* No concurrent amifostine or other protective reagents
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Gynecologic Oncology Group
NETWORK
Principal Investigators
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Agustin Garcia, MD
Role: STUDY_CHAIR
University of Southern California
Locations
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University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States
Chao Family Comprehensive Cancer Center
Orange, California, United States
University of Colorado Cancer Center
Denver, Colorado, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
Holden Comprehensive Cancer Center at The University of Iowa
Iowa City, Iowa, United States
Radiation Oncology Branch
Bethesda, Maryland, United States
Tufts University School of Medicine
Boston, Massachusetts, United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Cooper Hospital/University Medical Center
Camden, New Jersey, United States
State University of New York Health Science Center at Brooklyn
Brooklyn, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, United States
Abington Memorial Hospital
Abington, Pennsylvania, United States
Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Tom Baker Cancer Center - Calgary
Calgary, Alberta, Canada
Countries
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References
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Garcia AA, Blessing JA, Lenz HJ, Darcy KM, Mannel RS, Miller DS, Husseinzadeh N; Gynecologic Oncology Group. Phase II clinical trial of capecitabine in ovarian carcinoma recurrent 6-12 months after completion of primary chemotherapy, with exploratory TS, DPD, and TP correlates: a Gynecologic Oncology Group study. Gynecol Oncol. 2005 Mar;96(3):810-7. doi: 10.1016/j.ygyno.2004.11.037.
Other Identifiers
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GOG-0146L
Identifier Type: -
Identifier Source: secondary_id
CDR0000068330
Identifier Type: -
Identifier Source: org_study_id
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