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Sponsors and Collaborators: |
Norris Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003449 |
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 dexamethasone plus paclitaxel and gemcitabine in treating patients with platinum-resistant recurrent ovarian cancer.
Condition | Intervention | Phase |
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Ovarian Cancer |
Drug: dexamethasone Drug: gemcitabine hydrochloride Drug: paclitaxel |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase II Study of Weekly Paclitaxel and Gemcitabine in Platinum-Resistant Ovarian Cancer |
Estimated Enrollment: | 35 |
Study Start Date: | May 1998 |
OBJECTIVES:
OUTLINE: Patients are stratified according to prior treatment with paclitaxel (none or relapse more than 6 months after paclitaxel versus progressive disease or relapse less than 6 months after paclitaxel).
Patients receive dexamethasone IV, then paclitaxel IV followed by gemcitabine IV, for 3 consecutive weeks on days 1, 8, and 15. Treatment is continued every 4 weeks in the absence of disease progression or unacceptable toxicity.
All patients are followed until death.
PROJECTED ACCRUAL: Approximately 18-35 patients 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:
Platinum resistant disease defined as:
Measurable or evaluable disease
PATIENT CHARACTERISTICS:
Age:
Performance status:
Hematopoietic:
Hepatic:
Renal:
Neurologic:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, California | |
USC/Norris Comprehensive Cancer Center and Hospital | |
Los Angeles, California, United States, 90033-0804 |
Study Chair: | Agustin Garcia, MD | Norris Comprehensive Cancer Center |
Study ID Numbers: | CDR0000066478, LAC-USC-5O981, NCI-G98-1460 |
Study First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003449 |
Health Authority: | United States: Federal Government |
recurrent ovarian epithelial cancer |
Dexamethasone Ovarian cancer Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases |
Ovarian epithelial cancer Recurrence Genital Diseases, Female Paclitaxel Endocrinopathy Gemcitabine Dexamethasone acetate Endocrine Gland Neoplasms |
Anti-Inflammatory Agents Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Hormones Neoplasms by Site Therapeutic Uses Antineoplastic Agents, Hormonal Mitosis Modulators |
Gastrointestinal Agents Enzyme Inhibitors Antimitotic Agents Glucocorticoids Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Adnexal Diseases Neoplasms Radiation-Sensitizing Agents Autonomic Agents Tubulin Modulators Peripheral Nervous System Agents Antineoplastic Agents, Phytogenic Central Nervous System Agents |