- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00006812
Capecitabine in Treating Patients With Recurrent Ovarian Epithelial or Primary Peritoneal Cavity Cancer
Phase II Evaluation Of Capecitabine In Recurrent Platinum-Sensitive Ovarian Or Primary Peritoneal Cancer
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 capecitabine in treating patients who have recurrent ovarian epithelial or primary peritoneal cavity cancer.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
- 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.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
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Alberta
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Calgary, Alberta, Canada, T2N 4N2
- Tom Baker Cancer Center - Calgary
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Alabama
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Birmingham, Alabama, United States, 35294-3300
- University of Alabama at Birmingham Comprehensive Cancer Center
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California
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Los Angeles, California, United States, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Los Angeles, California, United States, 90033-0804
- USC/Norris Comprehensive Cancer Center and Hospital
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Orange, California, United States, 92868
- Chao Family Comprehensive Cancer Center
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Colorado
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Denver, Colorado, United States, 80010
- University of Colorado Cancer Center
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Florida
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Tampa, Florida, United States, 33612-9497
- H. Lee Moffitt Cancer Center and Research Institute
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Illinois
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Chicago, Illinois, United States, 60612
- Rush-Presbyterian-St. Luke's Medical Center
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Indiana
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Indianapolis, Indiana, United States, 46202-5289
- Indiana University Cancer Center
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Iowa
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Iowa City, Iowa, United States, 52242-1009
- Holden Comprehensive Cancer Center at the University of Iowa
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Maryland
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Bethesda, Maryland, United States, 20892
- Radiation Oncology Branch
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Massachusetts
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Boston, Massachusetts, United States, 02111
- Tufts University School of Medicine
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Worcester, Massachusetts, United States, 01655
- University of Massachusetts Memorial Medical Center
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota Cancer Center
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Rochester, Minnesota, United States, 55905
- Mayo Clinic Cancer Center
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Missouri
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Columbia, Missouri, United States, 65203
- Ellis Fischel Cancer Center - Columbia
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Saint Louis, Missouri, United States, 63110
- Washington University School of Medicine
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New Jersey
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Camden, New Jersey, United States, 08103
- Cooper Hospital/University Medical Center
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New York
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Brooklyn, New York, United States, 11203
- State University of New York Health Science Center at Brooklyn
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New York, New York, United States, 10021
- Memorial Sloan-Kettering Cancer Center
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Stony Brook, New York, United States, 11790-7775
- State University of New York Health Sciences Center - Stony Brook
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North Carolina
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Chapel Hill, North Carolina, United States, 27599-7295
- Lineberger Comprehensive Cancer Center, UNC
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Durham, North Carolina, United States, 27710
- Duke Comprehensive Cancer Center
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Winston-Salem, North Carolina, United States, 27157-1082
- Comprehensive Cancer Center at Wake Forest University
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Ohio
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic Taussig Cancer Center
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Columbus, Ohio, United States, 43210-1240
- Arthur G. James Cancer Hospital - Ohio State University
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73190
- University of Oklahoma College of Medicine
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Pennsylvania
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Abington, Pennsylvania, United States, 19001
- Abington Memorial Hospital
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Hershey, Pennsylvania, United States, 17033
- Milton S. Hershey Medical Center
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Philadelphia, Pennsylvania, United States, 19107-5541
- Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
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Texas
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Houston, Texas, United States, 77030-4009
- University of Texas - MD Anderson Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
- Histologically proven recurrent ovarian epithelial or primary peritoneal cavity cancer
Measurable disease
- At least 1 unidimensionally measurable lesion
- Ascites and pleural effusions are not considered measurable disease
Prior therapy must include 1 platinum-based chemotherapy regimen for primary disease containing carboplatin, cisplatin, or another organoplatinum compound
- Treatment-free interval of 6-12 months after response to platinum therapy
- Not eligible for higher priority GOG protocol
PATIENT CHARACTERISTICS:
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Agustin Garcia, MD, University of Southern California
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000068330
- GOG-0146L
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ovarian Cancer
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Roswell Park Cancer InstituteCompletedFallopian Tube Carcinoma | Primary Peritoneal Carcinoma | Stage IIA Ovarian Cancer | Stage IIB Ovarian Cancer | Stage IIC Ovarian Cancer | Stage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian Cancer | Stage IA Ovarian Cancer | Stage IB Ovarian Cancer | Stage IC... and other conditionsUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedCancer Survivor | Stage IIIA Ovarian Epithelial Cancer | Stage IIIB Ovarian Epithelial Cancer | Stage IIIC Ovarian Epithelial Cancer | Stage IIA Ovarian Epithelial Cancer | Stage IIB Ovarian Epithelial Cancer | Stage IIC Ovarian Epithelial Cancer | Stage IA Ovarian Epithelial Cancer | Stage IB Ovarian... and other conditionsUnited States
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Massachusetts General HospitalJohns Hopkins University; M.D. Anderson Cancer Center; National Cancer Institute... and other collaboratorsRecruitingOvarian Neoplasms | Fallopian Tube Neoplasms | Stage III Ovarian Cancer AJCC v8 | Stage IIIA Ovarian Cancer AJCC v8 | Stage IIIA1 Ovarian Cancer AJCC v8 | Stage IIIA2 Ovarian Cancer AJCC v8 | Stage IIIB Ovarian Cancer AJCC v8 | Stage IIIC Ovarian Cancer AJCC v8 | Stage IV Ovarian Cancer AJCC v8 | Stage... and other conditionsUnited States
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedOvarian Clear Cell Cystadenocarcinoma | Ovarian Endometrioid Adenocarcinoma | Ovarian Seromucinous Carcinoma | Ovarian Serous Cystadenocarcinoma | Stage IV Ovarian Germ Cell Tumor | Ovarian Sarcoma | Malignant Ovarian Epithelial Tumor | Ovarian Carcinosarcoma | Ovarian Brenner Tumor | Ovarian Mucinous... and other conditionsUnited States
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedStage IIA Fallopian Tube Cancer | Stage IIA Ovarian Cancer | Stage IIB Fallopian Tube Cancer | Stage IIB Ovarian Cancer | Stage IIC Fallopian Tube Cancer | Stage IIC Ovarian Cancer | Stage IIIA Fallopian Tube Cancer | Stage IIIA Ovarian Cancer | Stage IIIA Primary Peritoneal Cancer | Stage IIIB Fallopian... and other conditionsUnited States
-
University of WashingtonNational Cancer Institute (NCI)CompletedCaregiver | Stage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian CancerUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...CompletedStage I Breast Cancer | Stage I Uterine Corpus Cancer | Stage II Uterine Corpus Cancer | Stage III Uterine Corpus Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage... and other conditionsUnited States
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Eve RodlerNot yet recruitingBreast Cancer | Ovarian Cancer | Breast Neoplasm | Breast Carcinoma | Breast Cancer Stage IV | Breast Cancer Stage I | Breast Cancer Stage II | Invasive Breast Cancer | Cancer, Breast | Breast Cancer Stage III | Ovary Cancer | Malignant Tumor of Breast | Ovarian Cancer Stage IIIC | Ovarian Cancer Stage IV | Ovarian Cancer... and other conditionsUnited States
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)RecruitingStage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian CancerUnited States
-
University of WashingtonMinnesota Ovarian Cancer AllianceTerminatedStage III Ovarian Cancer AJCC v8 | Stage IIIA Ovarian Cancer AJCC v8 | Stage IIIA1 Ovarian Cancer AJCC v8 | Stage IIIA2 Ovarian Cancer AJCC v8 | Stage IIIB Ovarian Cancer AJCC v8 | Stage IIIC Ovarian Cancer AJCC v8 | Stage IV Ovarian Cancer AJCC v8 | Stage IVA Ovarian Cancer AJCC v8 | Stage IVB Ovarian... and other conditionsUnited States
Clinical Trials on capecitabine
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Sun Yat-sen UniversityChengdu Biostar PharmaceuticalsNot yet recruitingBreast Neoplasms | Locally Advanced or Metastatic Breast CancerChina
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityRecruiting
-
Hoffmann-La RocheCompletedBreast Cancer, Colorectal CancerNew Zealand, Australia, United Kingdom
-
Samsung Medical CenterCompletedAdvanced or Recurrent Esophageal Squamous Cell CarcinomaKorea, Republic of
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Fudan UniversityCompletedMetastatic Breast CancerChina
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Binghe XuHoffmann-La RocheUnknownSkin Diseases | Neoplasms by Site | Breast Neoplasms | Breast Diseases | Neoplasm MetastasisChina
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Cancer Institute and Hospital, Chinese Academy...Hoffmann-La RocheUnknownCarcinoma, Invasive Ductal, BreastChina
-
Jules Bordet InstituteCompletedBreast Cancer | Elderly PatientsBelgium
-
The First Affiliated Hospital of Zhengzhou UniversityRecruiting
-
Jiangxi Provincial Cancer HospitalNot yet recruitingNasopharyngeal Carcinoma | Maintenance Therapy | High-Risk Cancer