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


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Germ Cell Tumor, Extracranial, Childhood

 




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

This study is no longer recruiting patients.

Sponsored by: Memorial Sloan-Kettering Cancer Center
Information provided by: National Cancer Institute (NCI)

Purpose

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 Treatment or Intervention Phase
recurrent testicular cancer
recurrent ovarian germ cell tumor
 Procedure: chemotherapy
 Procedure: biological response modifier therapy
 Procedure: colony-stimulating factor therapy
 Procedure: cytokine therapy
 Drug: cisplatin
 Drug: filgrastim
 Drug: ifosfamide
 Drug: paclitaxel
Phase I
Phase II

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapy;   Ovarian Cancer;   Testicular Cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Phase I/II Study of Paclitaxel, Ifosfamide, and Cisplatin in Patients With Germ Cell Tumors With Favorable Prognostic Factors and Resistance to Cisplatin

Further Study Details: 

Study start: January 1994

OBJECTIVES: I. 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. II. Determine the efficacy of this regimen as salvage therapy in these patients.

PROTOCOL 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.

Eligibility

Ages Eligible for Study:  15 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

--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

--Patient Characteristics--

  • Age: 15 and over
  • Performance status: Not specified
  • Life expectancy: Not specified
  • Hematopoietic: WBC at least 3,000/mm3; Platelet count at least 100,000/mm3; 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

Location Information


New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States

Study chairs or principal investigators

Robert J. Motzer,  Study Chair,  Memorial Sloan-Kettering Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000063452; MSKCC-94012; NCI-V94-0408
Record last reviewed:  September 2003
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002559
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 8, 2005

Resources



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December 2, 2009



Page Updated: September 23, 2004
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