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

Sponsor
Memorial Sloan Kettering Cancer Center (Other)
Overall Status
Completed
CT.gov ID
NCT00002559
Collaborator
(none)
43
Enrollment
1
Location
108
Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
43 participants
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
Study Start Date :
Jan 1, 1994
Actual Primary Completion Date :
Jan 1, 2003
Actual Study Completion Date :
Jan 1, 2003

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    15 Years and Older
    Sexes Eligible for Study:
    All
    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

    Locations

    Site City State Country Postal Code
    1 Memorial Sloan-Kettering Cancer Center New York New York United States 10021

    Sponsors and Collaborators

    • Memorial Sloan Kettering Cancer Center

    Investigators

    • Study Chair: Robert J. Motzer, MD, Memorial Sloan Kettering Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00002559
    Other Study ID Numbers:
    • 94-012
    • CDR0000063452
    • NCI-V94-0408
    First Posted:
    Sep 18, 2003
    Last Update Posted:
    Jul 2, 2013
    Last Verified:
    Jul 1, 2013
    Keywords provided by , ,
    recurrent malignant testicular germ cell tumor
    recurrent ovarian germ cell tumor
    Additional relevant MeSH terms:
    Neoplasms, Germ Cell and Embryonal
    Paclitaxel
    Ifosfamide

    Study Results

    No Results Posted as of Jul 2, 2013