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Combination Chemotherapy in Treating Patients With Germ Cell Tumors That Have Not Responded to Previous Cisplatin
This study is ongoing, but not recruiting participants.
Study NCT00002559   Information provided by National Cancer Institute (NCI)
First Received: November 1, 1999   Last Updated: February 6, 2009   History of Changes

November 1, 1999
February 6, 2009
January 1994
 
 
 
Complete list of historical versions of study NCT00002559 on ClinicalTrials.gov Archive Site
 
 
 
Combination Chemotherapy in Treating Patients With Germ Cell Tumors That Have Not Responded to Previous Cisplatin
PHASE I/II TRIAL OF TAXOL, IFOSFAMIDE, AND CISPLATIN FOR CISPLATIN-RESISTANT GERM CELL TUMOR PATIENTS WITH FAVORABLE PROGNOSTIC FEATURES

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.

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.

Phase I, Phase II
Interventional
Treatment
  • Ovarian Cancer
  • Testicular Germ Cell Tumor
  • Biological: filgrastim
  • Drug: cisplatin
  • Drug: ifosfamide
  • Drug: paclitaxel
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
43
 
 

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
Both
15 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002559
 
CDR0000063452, MSKCC-94012, NCI-V94-0408
Memorial Sloan-Kettering Cancer Center
 
Study Chair: Robert J. Motzer, MD Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
September 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP