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Sponsors and Collaborators: |
New York University School of Medicine National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005051 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have advanced ovarian epithelial cancer.
Condition | Intervention | Phase |
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Ovarian Cancer |
Drug: carboplatin Drug: cisplatin Drug: paclitaxel Drug: topotecan hydrochloride |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase II Study of First-Line Therapy of Ovarian Cancer With Sequential Regimens: Cisplatin-Prolonged Oral Topotecan (C-PORT) Followed by Paclitaxel/Carboplatin (PC) |
Study Start Date: | August 1999 |
OBJECTIVES:
OUTLINE:
PROJECTED ACCRUAL: A total of 30 patients (15 per arm) will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed advanced ovarian epithelial carcinoma, regardless of quantity of disease post-surgery
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United States, New York | |
Albert Einstein Clinical Cancer Center | |
Bronx, New York, United States, 10461 | |
Herbert Irving Comprehensive Cancer Center at Columbia University | |
New York, New York, United States, 10032 | |
Mount Sinai Medical Center, NY | |
New York, New York, United States, 10029 | |
New York Hospital Medical Center of Queens | |
Fresh Meadows, New York, United States, 11365 | |
New York Medical College | |
Valhalla, New York, United States, 10595 | |
New York Weill Cornell Cancer Center at Cornell University | |
New York, New York, United States, 10021 | |
NYU School of Medicine's Kaplan Comprehensive Cancer Center | |
New York, New York, United States, 10016 | |
Saint Vincent Catholic Medical Center of New York | |
New York, New York, United States, 10011 | |
St. Luke's-Roosevelt Hospital Center - Roosevelt Division | |
New York, New York, United States, 10019 | |
United States, Wisconsin | |
University of Wisconsin Comprehensive Cancer Center | |
Madison, Wisconsin, United States, 53792-3236 |
Study Chair: | Howard S. Hochster, MD | New York University School of Medicine |
Study ID Numbers: | CDR0000067644, NYU-9913, NCI-G00-1720 |
Study First Received: | April 6, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00005051 History of Changes |
Health Authority: | United States: Federal Government |
stage I ovarian epithelial cancer stage II ovarian epithelial cancer stage III ovarian epithelial cancer stage IV ovarian epithelial cancer |
Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Antimitotic Agents Ovarian Diseases Carboplatin Ovarian Epithelial Cancer Genital Diseases, Female |
Radiation-Sensitizing Agents Cisplatin Paclitaxel Tubulin Modulators Ovarian Cancer Endocrinopathy Topotecan Antineoplastic Agents, Phytogenic Endocrine Gland Neoplasms |
Molecular Mechanisms of Pharmacological Action Gonadal Disorders Antineoplastic Agents Physiological Effects of Drugs Urogenital Neoplasms Ovarian Diseases Genital Diseases, Female Neoplasms by Site Cisplatin Therapeutic Uses Endocrine Gland Neoplasms Ovarian Neoplasms Mitosis Modulators |
Genital Neoplasms, Female Endocrine System Diseases Enzyme Inhibitors Carboplatin Antimitotic Agents Pharmacologic Actions Adnexal Diseases Neoplasms Radiation-Sensitizing Agents Paclitaxel Tubulin Modulators Topotecan Antineoplastic Agents, Phytogenic |