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Sponsors and Collaborators: |
Gynecologic Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00006812 |
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.
Condition | Intervention | Phase |
---|---|---|
Ovarian Cancer Peritoneal Cavity Cancer |
Drug: capecitabine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase II Evaluation Of Capecitabine In Recurrent Platinum-Sensitive Ovarian Or Primary Peritoneal Cancer |
Study Start Date: | March 2001 |
OBJECTIVES:
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.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Measurable disease
Prior therapy must include 1 platinum-based chemotherapy regimen for primary disease containing carboplatin, cisplatin, or another organoplatinum compound
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Study Chair: | Agustin Garcia, MD | Norris Comprehensive Cancer Center |
Study ID Numbers: | CDR0000068330, GOG-0146L |
Study First Received: | December 6, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00006812 |
Health Authority: | United States: Federal Government |
recurrent ovarian epithelial cancer peritoneal cavity cancer |
Ovarian cancer Capecitabine Ovarian Neoplasms Digestive System Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Ovarian epithelial cancer |
Abdominal Neoplasms Recurrence Genital Diseases, Female Digestive System Diseases Peritoneal Diseases Gastrointestinal Neoplasms Endocrinopathy Peritoneal Neoplasms Endocrine Gland Neoplasms |
Antimetabolites Neoplasms Antimetabolites, Antineoplastic Neoplasms by Site Molecular Mechanisms of Pharmacological Action |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Adnexal Diseases |