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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002559
Recruitment Status : Completed
First Posted : September 18, 2003
Last Update Posted : July 2, 2013
Information provided by:
Memorial Sloan Kettering Cancer Center

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
Ovarian Cancer Testicular Germ Cell Tumor Biological: filgrastim Drug: cisplatin Drug: ifosfamide Drug: paclitaxel Phase 1 Phase 2

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 43 participants
Primary Purpose: Treatment
Study Start Date : January 1994
Actual Primary Completion Date : January 2003
Actual Study Completion Date : January 2003

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 15 and over

Performance status:

  • Not specified

Life expectancy:

  • Not specified


  • WBC at least 3,000/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 8.0 g/dL


  • Not specified


  • Creatinine clearance greater than 50 mL/min
  • Renal dysfunction due to ureteral obstruction by tumor allowed at the discretion of the principal investigator


  • If history of significant cardiac disease, evaluation and clearance by a cardiologist required prior to entry


  • No active infection not well controlled on antibiotics


Biologic therapy:

  • Not specified


  • See Disease Characteristics
  • No prior paclitaxel or ifosfamide
  • At least 3 weeks since prior chemotherapy
  • No other concurrent chemotherapy

Endocrine therapy:

  • Not specified


  • Not specified


  • See Disease Characteristics
  • Recovered from recent surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00002559

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United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
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Study Chair: Robert J. Motzer, MD Memorial Sloan Kettering Cancer Center

Layout table for additonal information Identifier: NCT00002559     History of Changes
Other Study ID Numbers: 94-012
CDR0000063452 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: September 18, 2003    Key Record Dates
Last Update Posted: July 2, 2013
Last Verified: July 2013

Keywords provided by Memorial Sloan Kettering Cancer Center:
recurrent malignant testicular germ cell tumor
recurrent ovarian germ cell tumor

Additional relevant MeSH terms:
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Neoplasms, Germ Cell and Embryonal
Testicular Neoplasms
Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Neoplasms by Site
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Endocrine System Diseases
Testicular Diseases
Gonadal Disorders
Isophosphamide mustard
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action