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

Testicular Germ Cell Tumor Clinical Trial

Official title:

A Study of Paclitaxel, Cisplatin and Ifosfamide as Induction Therapy in the Treatment of Patients Relapsing After BEP Chemotherapy for Metastatic Germ Cell Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004077
• Other study ID #: CDR0000067286
• Secondary ID: MRC-TIPEU-99012
• Status: Completed
• Phase: Phase 2
• First received: December 10, 1999
• Last updated: December 18, 2013
• Start date: May 1996
• Est. completion date: July 2005

Study information

• Verified date: January 2001
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 16 Years to 64 Years

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms, Germ Cell and Embryonal
• Testicular Germ Cell Tumor
• Testicular Neoplasms

Intervention

Drug:
• cisplatin

• ifosfamide

• paclitaxel

Locations

Country	Name	City	State
United Kingdom	Velindre Hospital	Cardiff	Wales

Sponsors (1)

Lead Sponsor	Collaborator
Medical Research Council

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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 m — View Citation