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Paclitaxel, Ifosfamide, and Cisplatin in Treating Patients With Metastatic Testicular Cancer - Article


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Paclitaxel

Onxol; Taxol


Clinical Trial: Paclitaxel, Ifosfamide, and Cisplatin in Treating Patients With Metastatic Testicular Cancer

This study is no longer recruiting patients.

Sponsored by: Medical Research Council
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 II trial to study the effectiveness of combining paclitaxel, ifosfamide, and cisplatin in treating patients who have metastatic testicular cancer that has recurred following treatment.

Condition Treatment or Intervention Phase
Testicular Cancer
Reproductive Cancer
 Drug: cisplatin
 Drug: ifosfamide
 Drug: paclitaxel
 Procedure: chemotherapy
Phase II

MedlinePlus related topics:  Testicular Cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Paclitaxel, Ifosfamide, and Cisplatin in Patients With Metastatic Nonseminomatous Germ Cell Tumor of the Testis in First Relapse Following First Line Treatment With Bleomycin, Etoposide, and Cisplatin

Further Study Details: 

OBJECTIVES:

  • Determine the feasibility of combining paclitaxel, ifosfamide, and cisplatin induction in patients with metastatic nonseminomatous germ cell tumor of the testis in first relapse following first line treatment with bleomycin, etoposide, and cisplatin.
  • Determine the response rates to this regimen in these patients

OUTLINE: This is a multicenter study.

Patients receive paclitaxel IV over 3 hours and ifosfamide IV and cisplatin IV daily for 5 days. Patients with stable or responding disease repeat treatment every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A minimum of 25 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:  16 Years   -   64 Years,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

  • Metastatic nonseminomatous germ cell tumor of the testis
  • In first relapse following first line treatment with bleomycin, etoposide, and cisplatin
  • Biopsy proven germ cell tumor OR
  • Rising tumor markers (alpha fetoprotein and/or human chorionic gonadotropin)
  • No brain metastases

PATIENT CHARACTERISTICS: Age:

  • 16 to 64

Performance status:

  • 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Glomerular filtration rate greater than 50 mL/min

Other:

PRIOR CONCURRENT THERAPY: Biologic therapy:

  • Not specified

Chemotherapy:

  • See Disease Characteristics

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • Not specified

Other:


Location Information


United Kingdom, Wales
      Velindre Hospital, Cardiff,  Wales,  CF14 2TL,  United Kingdom

Study chairs or principal investigators

Malcolm D. Mason, MD,  Study Chair,  Velindre Hospital   

More Information

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

Study ID Numbers:  CDR0000067286; MRC-TIP; EU-99012
Record last reviewed:  May 2003
Last Updated:  October 13, 2004
Record first received:  December 10, 1999
ClinicalTrials.gov Identifier:  NCT00004077
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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October 6, 2008



Page Updated: June 1, 2005
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