Bleomycin, Etoposide, and Cisplatin in Treating Patients With Metastatic Germ Cell Cancer of the Testicles

Sponsor

Queen Mary University of London (Other)

Overall Status

Completed

CT.gov ID

NCT00324298

Collaborator

(none)

210

Enrollment

Locations

Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as bleomycin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known which schedule of bleomycin is more effective when given together with etoposide and cisplatin in treating metastatic germ cell cancer of the testicles.

PURPOSE: This randomized phase III trial is studying two different schedules of bleomycin to compare how well they work when given together with etoposide and cisplatin in treating patients with metastatic germ cell cancer of the testicles.

Condition or Disease	Intervention/Treatment	Phase
Drug/Agent Toxicity by Tissue/Organ Testicular Germ Cell Tumor	Biological: bleomycin sulfate Drug: cisplatin Drug: etoposide Procedure: management of therapy complications	Phase 3

Detailed Description

OBJECTIVES:

Primary

Determine if long-infusion schedule of bleomycin is less toxic to the lungs than short-infusion schedule of bleomycin in patients who are undergoing combination chemotherapy comprising bleomycin, etoposide, and cisplatin for good-prognosis, metastatic germ cell cancer of the testes.
Determine if early lung function tests are a predictor for late toxicity.
Determine if any indication of enhanced response to the long-infusion schedule justifies a large-scale phase III evaluation.
Validate the O'Sullivan et al prognostic scoring system for bleomycin toxicity.

Secondary

Determine response to treatment.
Determine progression-free survival and overall survival of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (≤ 30 years vs > 30 years), current smoker or has smoked within the past 1 year (yes vs no), and creatinine clearance (≤ 80 mL/min vs > 80 mL/min). Patients are randomized to 1 of 2 treatment arms.

Arm I (short-infusion schedule of bleomycin): Patients receive etoposide IV over 2 hours on days 1-3, cisplatin IV over 4 hours on days 1 and 2, and bleomycin IV over 30 minutes on days 2, 8, and 15.
Arm II (long-infusion schedule of bleomycin): Patients receive etoposide and cisplatin as in arm I. Patients also receive bleomycin IV continuously over 72 hours on days 1-3.

In both arms, treatment repeats every 3 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 4 weeks and then every 3 months for 24 months.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 210 patients will be accrued for this study.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

210 participants

Allocation:

Randomized

Primary Purpose:

Treatment

Official Title:

A Randomized Phase III Toxicity Study of Day 2, 3, 8, 15 Short (30 Minute) Versus Day 1, 2, 3 Long (72 Hours) Infusion Bleomycin for Patients With IGCCCG Good Prognosis Germ Cell Tumors, TE3

Study Start Date :

Jul 1, 2003

Actual Study Completion Date :

Mar 1, 2011

Outcome Measures

Primary Outcome Measures

Pulmonary toxicity []

Secondary Outcome Measures

Response to treatment []
Progression-free survival []
Overall survival []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Diagnosis of metastatic germ cell cancer of the testes
Good-prognosis disease
Eligible for treatment with bleomycin, etoposide, and cisplatin

PATIENT CHARACTERISTICS:

Creatinine clearance ≥ 60 mL/min
No other prior or concurrent malignancy except basal cell skin cancer
No other major systemic illness
No impaired respiratory function, including any of the following:
Shortness of breath on minimal exertion
Hypoxia at rest
Carbon monoxide transfer, total lung capacity, and FEV_1 > 60% of predicted

PRIOR CONCURRENT THERAPY:

No prior chemotherapy or radiotherapy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Basildon University Hospital	Basildon	England	United Kingdom	SS16 5NL
2	Addenbrooke's Hospital	Cambridge	England	United Kingdom	CB2 2QQ
3	Essex County Hospital	Colchester	England	United Kingdom	C03 3NB
4	Ipswich Hospital	Ipswich	England	United Kingdom	IP4 5PD
5	Leeds Cancer Centre at St. James's University Hospital	Leeds	England	United Kingdom	LS9 7TF
6	Saint Bartholomew's Hospital	London	England	United Kingdom	EC1A 7BE
7	University College of London Hospitals	London	England	United Kingdom	WIT 3AA
8	Norfolk and Norwich University Hospital	Norwich	England	United Kingdom	NR4 7UY
9	Royal Marsden - Surrey	Sutton	England	United Kingdom	SM2 5PT
10	Southend University Hospital NHS Foundation Trust	Westcliff-On-Sea	England	United Kingdom	SS0 0RY