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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00004077

First Posted: January 27, 2003

Last Update Posted: December 19, 2013

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

National Cancer Institute (NCI)

Tracking Information

First Submitted Date ^ICMJE

December 10, 1999

First Posted Date ^ICMJE

January 27, 2003

Last Update Posted Date

December 19, 2013

Start Date ^ICMJE

May 1996

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00004077 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Primary Purpose: Treatment

Condition ^ICMJE

Testicular Germ Cell Tumor

Intervention ^ICMJE

Drug: cisplatin
Drug: ifosfamide
Drug: paclitaxel

Study Arms

Not Provided

Publications *

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.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

July 2005

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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:

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

Sex/Gender

Sexes Eligible for Study:

Male

Ages

16 Years to 64 Years (Child, Adult)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United Kingdom

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00004077

Other Study ID Numbers ^ICMJE

CDR0000067286
MRC-TIP
EU-99012

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Medical Research Council

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Malcolm D. Mason, MD

Velindre NHS Trust

PRS Account

National Cancer Institute (NCI)

Verification Date

January 2001

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

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