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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: | NCT00006267 |
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 nitrocamptothecin in treating patients who have recurrent or metastatic ovarian epithelial or primary peritoneal cancer.
Condition | Intervention | Phase |
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Ovarian Cancer Peritoneal Cavity Cancer |
Drug: rubitecan |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase II Evaluation Of 9-Nitro-Camptothecin In The Third-Line Treatment Of Recurrent Ovarian Or Primary Peritoneal Cancer |
OBJECTIVES:
OUTLINE: Patients receive oral nitrocamptothecin on days 1-5. Treatment continues every 7 days in the absence of disease progression or unacceptable toxicity.
Patients are followed at 2 weeks, then every 3 months for 2 years, and then every 6 months for 3 years.
PROJECTED ACCRUAL: Approximately 19-51 patients will be accrued for this study within 22 months.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Measurable disease
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Study ID Numbers: | CDR0000068210, GOG-0186B |
Study First Received: | September 11, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00006267 History of Changes |
Health Authority: | United States: Federal Government |
stage IV ovarian epithelial cancer recurrent ovarian epithelial cancer peritoneal cavity cancer |
Ovarian Neoplasms Digestive System Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases 9-nitrocamptothecin Ovarian Epithelial Cancer Abdominal Neoplasms |
Camptothecin Recurrence Genital Diseases, Female Digestive System Diseases Peritoneal Diseases Ovarian Cancer Gastrointestinal Neoplasms Endocrinopathy Peritoneal Neoplasms Endocrine Gland Neoplasms |
Digestive System Neoplasms Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Abdominal Neoplasms |
Adnexal Diseases Genital Diseases, Female Neoplasms Digestive System Diseases Neoplasms by Site Peritoneal Diseases Peritoneal Neoplasms Endocrine Gland Neoplasms |