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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00004077
First received: December 10, 1999
Last updated: December 18, 2013
Last verified: January 2001
History of Changes
December 10, 1999
December 18, 2013
May 1996
Not Provided
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Complete list of historical versions of study NCT00004077 on ClinicalTrials.gov Archive Site
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Paclitaxel, Ifosfamide, and Cisplatin in Treating Patients With Metastatic Testicular Cancer
A Study of Paclitaxel, Cisplatin and Ifosfamide as Induction Therapy in the Treatment of Patients Relapsing After BEP Chemotherapy for Metastatic Germ Cell Tumors

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.

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.
Interventional
Phase 2
Primary Purpose: Treatment
Testicular Germ Cell Tumor
  • Drug: cisplatin
  • Drug: ifosfamide
  • Drug: paclitaxel
Not Provided
Mead GM, Cullen MH, Huddart R, Harper P, Rustin GJ, Cook PA, Stenning SP, Mason M; MRC Testicular Tumour Working Party. A phase II trial of TIP (paclitaxel, ifosfamide and cisplatin) given as second-line (post-BEP) salvage chemotherapy for patients with metastatic germ cell cancer: a medical research council trial. Br J Cancer. 2005 Jul 25;93(2):178-84.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
July 2005
Not Provided

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:

  • No other prior malignancy except curatively treated nonmelanomatous skin cancer or superficial bladder cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • See Disease Characteristics

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • Not specified

Other:

  • No prior experimental drugs
Sexes Eligible for Study: Male
16 Years to 64 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT00004077
CDR0000067286
MRC-TIP
EU-99012
Not Provided
Not Provided
Not Provided
Not Provided
Medical Research Council
Not Provided
Study Chair: Malcolm D. Mason, MD Velindre NHS Trust
National Cancer Institute (NCI)
January 2001

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