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Sponsored by: |
Memorial Sloan-Kettering Cancer Center |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00002559 |
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 I/II trial to study the effectiveness of combination chemotherapy consisting of paclitaxel, cisplatin, and ifosfamide in treating patients who have ovarian or testicular germ cell tumors that are refractory to platinum-containing chemotherapy.
Condition | Intervention | Phase |
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Ovarian Cancer Testicular Germ Cell Tumor |
Biological: filgrastim Drug: cisplatin Drug: ifosfamide Drug: paclitaxel |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | PHASE I/II TRIAL OF TAXOL, IFOSFAMIDE, AND CISPLATIN FOR CISPLATIN-RESISTANT GERM CELL TUMOR PATIENTS WITH FAVORABLE PROGNOSTIC FEATURES |
Estimated Enrollment: | 43 |
Study Start Date: | January 1994 |
OBJECTIVES:
OUTLINE: This is a dose escalation study of paclitaxel.
Patients receive paclitaxel IV continuously on day 1 and cisplatin IV over 20 minutes and ifosfamide IV over 30 minutes on days 2-6. Filgrastim (G-CSF) is administered subcutaneously (SC) on days 7-18 or until blood counts recover. Treatment continues every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of paclitaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 6 patients experience dose-limiting toxicity. Additional patients receive paclitaxel at the MTD.
After completion of chemotherapy, some patients may undergo resection of residual masses.
PROJECTED ACCRUAL: A total of 18-43 patients will be accrued for this study within 2 years.
Ages Eligible for Study: | 15 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Active disease meeting 1 of the following conditions:
Favorable prognostic factors for achieving a complete response (CR) to cisplatin-based salvage therapy required, including all of the following:
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 | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 |
Study Chair: | Robert J. Motzer, MD | Memorial Sloan-Kettering Cancer Center |
Study ID Numbers: | CDR0000063452, MSKCC-94012, NCI-V94-0408 |
Study First Received: | November 1, 1999 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00002559 History of Changes |
Health Authority: | United States: Federal Government |
recurrent malignant testicular germ cell tumor recurrent ovarian germ cell tumor |
Gonadal Disorders Urogenital Neoplasms Ovarian Diseases Genital Diseases, Female Cisplatin Neoplasms, Germ Cell and Embryonal Ovarian Cancer Alkylating Agents Endocrine Gland Neoplasms Ovarian Neoplasms Testicular Cancer Genital Neoplasms, Female Endocrine System Diseases |
Testicular Neoplasms Antimitotic Agents Recurrence Ifosfamide Radiation-Sensitizing Agents Paclitaxel Mechlorethamine Tubulin Modulators Endocrinopathy Antineoplastic Agents, Alkylating Antineoplastic Agents, Phytogenic Isophosphamide mustard |
Molecular Mechanisms of Pharmacological Action Gonadal Disorders Antineoplastic Agents Physiological Effects of Drugs Urogenital Neoplasms Ovarian Diseases Genital Diseases, Female Neoplasms by Site Cisplatin Neoplasms, Germ Cell and Embryonal Therapeutic Uses Alkylating Agents Endocrine Gland Neoplasms Neoplasms by Histologic Type Ovarian Neoplasms |
Mitosis Modulators Genital Neoplasms, Female Endocrine System Diseases Antimitotic Agents Pharmacologic Actions Adnexal Diseases Neoplasms Ifosfamide Radiation-Sensitizing Agents Paclitaxel Tubulin Modulators Antineoplastic Agents, Alkylating Antineoplastic Agents, Phytogenic Isophosphamide mustard |