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Capecitabine in Treating Women With Recurrent Ovarian Epithelial or Primary Peritoneal Cavity Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Capecitabine in Treating Women With Recurrent Ovarian Epithelial or Primary Peritoneal Cavity Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Capecitabine in Treating Women With Recurrent Ovarian Epithelial or Primary Peritoneal Cavity Cancer Clinical research trials and Capecitabine in Treating Women With Recurrent Ovarian Epithelial or Primary Peritoneal Cavity Cancer medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Capecitabine in Treating Women With Recurrent Ovarian Epithelial or Primary Peritoneal Cavity Cancer. Capecitabine in Treating Women With Recurrent Ovarian Epithelial or Primary Peritoneal Cavity Cancer Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Capecitabine in Treating Women With Recurrent Ovarian Epithelial or Primary Peritoneal Cavity Cancer clinical trial. Participants frequently obtain the most expert healthcare available for their Capecitabine in Treating Women With Recurrent Ovarian Epithelial or Primary Peritoneal Cavity Cancer condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Capecitabine in Treating Women With Recurrent Ovarian Epithelial or Primary Peritoneal Cavity Cancer  Capecitabine in Treating Women With Recurrent Ovarian Epithelial or Primary Peritoneal Cavity Cancer
Capecitabine in Treating Women With Recurrent Ovarian Epithelial or Primary Peritoneal Cavity Cancer
For Condition: recurrent ovarian epithelial cancer,peritoneal cavity cancer
Status: No longer recruiting
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 capecitabine in treating patients who have recurrent ovarian epithelial or primary peritoneal cavity cancer.
Details: OBJECTIVES: I. Determine the antitumor activity of capecitabine in women with recurrent, platinum-sensitive ovarian epithelial or primary peritoneal cavity cancer. II. Determine the nature and degree of toxicity of this drug in this patient population. PROTOCOL OUTLINE: This is a multicenter study. Patients receive oral capecitabine twice daily for 14 days. Treatment continues 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven recurrent ovarian epithelial or primary peritoneal cavity cancer - Measurable disease; 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 following response to platinum therapy - Not eligible for higher priority GOG protocol --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; No concurrent amifostine or other protective reagents - 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 --Patient Characteristics-- - Age: Any age - 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 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AgustinGarcia, Study Chair, Gynecologic Oncology Group
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Chao Family Comprehensive Cancer Center
Orange, California, 92868
United States
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, 60612
United States
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, 11790-7775
United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
United States
Washington University School of Medicine
St. Louis, Missouri, 63110
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289
United States
Radiation Oncology Branch
Bethesda, Maryland, 20892
United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203
United States
State University of New York Health Science Center at Brooklyn
Brooklyn, New York, 11203
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1082
United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107-5541
United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
Tufts University School of Medicine
Boston, Massachusetts, 02111
United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001
United States
Holden Comprehensive Cancer Center at The University of Iowa
Iowa City, Iowa, 52242-1009
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
United States
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294-3300
United States
Cooper Hospital/University Medical Center
Camden, New Jersey, 08103
United States
Tom Baker Cancer Center - Calgary
Calgary, Alberta, T2N 4N2
Canada
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, 73190
United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90033-0804
United States
University of Colorado Cancer Center
Denver, Colorado, 80010
United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497
United States
Additional Information:
Study ID Numbers: CDR0000068330; GOG-0146L
Study Start Date: March 2001
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006812
Other Recurrent Ovarian Epithelial Cancer Studies:
1. ZD 1839 in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
2. Docetaxel Plus Carboplatin in Treating Patients With Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
3. Platinum-based Chemotherapy With or Without Paclitaxel in Treating Patients With Relapsed Ovarian Cancer
4. BMS-247550 in Treating Patients With Ovarian Epithelial or Primary Peritoneal Cancer That Has Not Responded to Previous Chemotherapy
5. Paclitaxel in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer
Related Studies:
Other recurrent ovarian epithelial cancer Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Capecitabine in Treating Women With Recurrent Ovarian Epithelial or Primary Peritoneal Cavity Cancer
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