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

Primary Purpose

Testicular Germ Cell Tumor

Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
cisplatin
ifosfamide
paclitaxel
Sponsored by
Medical Research Council
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Testicular Germ Cell Tumor focused on measuring stage III malignant testicular germ cell tumor, recurrent malignant testicular germ cell tumor, testicular embryonal carcinoma, testicular choriocarcinoma, testicular teratoma, testicular yolk sac tumor, testicular embryonal carcinoma and teratoma, testicular embryonal carcinoma and yolk sac tumor, testicular yolk sac tumor and teratoma, testicular choriocarcinoma and yolk sac tumor, testicular choriocarcinoma and embryonal carcinoma, testicular choriocarcinoma and teratoma

Eligibility Criteria

16 Years - 64 Years (Child, Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Velindre Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
December 10, 1999
Last Updated
December 18, 2013
Sponsor
Medical Research Council
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1. Study Identification

Unique Protocol Identification Number
NCT00004077
Brief Title
Paclitaxel, Ifosfamide, and Cisplatin in Treating Patients With Metastatic Testicular Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2001
Overall Recruitment Status
Completed
Study Start Date
May 1996 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Medical Research Council

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Testicular Germ Cell Tumor
Keywords
stage III malignant testicular germ cell tumor, recurrent malignant testicular germ cell tumor, testicular embryonal carcinoma, testicular choriocarcinoma, testicular teratoma, testicular yolk sac tumor, testicular embryonal carcinoma and teratoma, testicular embryonal carcinoma and yolk sac tumor, testicular yolk sac tumor and teratoma, testicular choriocarcinoma and yolk sac tumor, testicular choriocarcinoma and embryonal carcinoma, testicular choriocarcinoma and teratoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
ifosfamide
Intervention Type
Drug
Intervention Name(s)
paclitaxel

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Malcolm D. Mason, MD
Organizational Affiliation
Velindre NHS Trust
Official's Role
Study Chair
Facility Information:
Facility Name
Velindre Hospital
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF14 2TL
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
15999102
Citation
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. doi: 10.1038/sj.bjc.6602682.
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Paclitaxel, Ifosfamide, and Cisplatin in Treating Patients With Metastatic Testicular Cancer

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