Combination Chemotherapy in Treating Patients With Germ Cell Tumors That Have Not Responded to Previous Cisplatin
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Purpose
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 |
|---|---|---|
|
Ovarian Cancer Testicular Germ Cell Tumor |
Biological: filgrastim Drug: cisplatin Drug: ifosfamide Drug: paclitaxel |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: 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 |
| Primary Completion Date: | January 2003 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- Determine the toxicity and optimal dose of paclitaxel when combined with cisplatin and ifosfamide in patients with germ cell tumors with favorable prognostic features and resistance to cisplatin.
- Determine the efficacy of this regimen as salvage therapy in these patients.
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.
Eligibility| Ages Eligible for Study: | 15 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
- Histologically proven germ cell tumor that is resistant to a platinum-based chemotherapy regimen
Active disease meeting 1 of the following conditions:
- Measurable or evaluable disease
- Elevated serum tumor markers (alpha-fetoprotein or human chorionic gonadotropin)
- Unresectable residual disease after postchemotherapy surgery
Favorable prognostic factors for achieving a complete response (CR) to cisplatin-based salvage therapy required, including all of the following:
- No more than 1 prior regimen or 6 prior courses of cisplatin
- Testis or ovarian germ cell primary site
- Prior CR to cisplatin therapy
- Incomplete response to first-line therapy that was based on either carboplatin or a suboptimal regimen of cisplatin
PATIENT CHARACTERISTICS:
Age:
- 15 and over
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- WBC at least 3,000/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 8.0 g/dL
Hepatic:
- Not specified
Renal:
- Creatinine clearance greater than 50 mL/min
- Renal dysfunction due to ureteral obstruction by tumor allowed at the discretion of the principal investigator
Cardiovascular:
- If history of significant cardiac disease, evaluation and clearance by a cardiologist required prior to entry
Other:
- No active infection not well controlled on antibiotics
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- See Disease Characteristics
- No prior paclitaxel or ifosfamide
- At least 3 weeks since prior chemotherapy
- No other concurrent chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- See Disease Characteristics
- Recovered from recent surgery
Contacts and Locations| 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 |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00002559 History of Changes |
| Other Study ID Numbers: | CDR0000063452, MSKCC-94012, NCI-V94-0408 |
| Study First Received: | November 1, 1999 |
| Last Updated: | December 3, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
recurrent malignant testicular germ cell tumor recurrent ovarian germ cell tumor |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Neoplasms, Germ Cell and Embryonal Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Neoplasms by Histologic Type Isophosphamide mustard Cisplatin |
Ifosfamide Paclitaxel Lenograstim Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Tubulin Modulators Antimitotic Agents Mitosis Modulators Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 23, 2013