PHASE I/II TRIAL OF TAXOL, IFOSFAMIDE, AND CISPLATIN FOR CISPLATIN-RESISTANT GERM CELL TUMOR PATIENTS WITH FAVORABLE PROGNOSTIC FEATURES
15 Years
N/A
Both
Ovarian Cancer, Testicular Germ Cell Tumor
Trial Information
PHASE I/II TRIAL OF TAXOL, IFOSFAMIDE, AND CISPLATIN FOR CISPLATIN-RESISTANT GERM CELL TUMOR PATIENTS WITH FAVORABLE PROGNOSTIC FEATURES
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Robert J. Motzer, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000063452
NCT ID:
NCT00002559
Start Date:
January 1994
Completion Date:
Related Keywords:
- Ovarian Cancer
- Testicular Germ Cell Tumor
- recurrent malignant testicular germ cell tumor
- recurrent ovarian germ cell tumor
- Ovarian Neoplasms
- Neoplasms, Germ Cell and Embryonal
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
