NCT00004077

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Medical Research Council · Other Government
• Sex: Male
• Age: 16 Years – 64 Years
• Healthy volunteers: Not accepted

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 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.

Detailed description

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.

Conditions

• Testicular Germ Cell Tumor

Interventions

Type	Name	Description
DRUG	cisplatin
DRUG	ifosfamide
DRUG	paclitaxel

Timeline

• Start date: 1996-05-01
• Completion: 2005-07-01
• First posted: 2003-01-27
• Last updated: 2013-12-19

Locations

1 site across 1 country: United Kingdom