Combination Chemotherapy in Treating Patients With Germ Cell Tumors That Have Not Responded to Previous Cisplatin

NCT ID: NCT00002559

Last Updated: 2013-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1994-01-31
• Study Completion Date: 2003-01-31

Brief Summary

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.

Detailed Description

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.

Conditions

Ovarian Cancer; Testicular Germ Cell Tumor

Study Design

• Primary Study Purpose: TREATMENT

Interventions

filgrastim

Intervention Type: BIOLOGICAL

cisplatin

Intervention Type: DRUG

ifosfamide

Intervention Type: DRUG

paclitaxel

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Principal Investigators

Robert J. Motzer, MD

Role: STUDY_CHAIR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Countries

United States

Other Identifiers

CDR0000063452

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-V94-0408

Identifier Type: -

Identifier Source: secondary_id

94-012

Identifier Type: -

Identifier Source: org_study_id