PHASE I/II TRIAL OF TAXOL, IFOSFAMIDE, AND CISPLATIN FOR CISPLATIN-RESISTANT GERM CELL TUMOR PATIENTS WITH FAVORABLE PROGNOSTIC FEATURES


Phase 1/Phase 2
15 Years
N/A
Not Enrolling
Both
Ovarian Cancer, Testicular Germ Cell Tumor

Thank you

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