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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00324298
Other study ID # BARTS-TE3
Secondary ID CDR0000472976EU-
Status Completed
Phase Phase 3
First received May 10, 2006
Last updated August 9, 2013
Start date July 2003
Est. completion date March 2011

Study information

Verified date January 2007
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority Unspecified
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 210
Est. completion date March 2011
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 50 Years
Eligibility 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

Study Design

Allocation: Randomized, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Biological:
bleomycin sulfate

Drug:
cisplatin

etoposide

Procedure:
management of therapy complications


Locations

Country Name City State
United Kingdom Basildon University Hospital Basildon England
United Kingdom Addenbrooke's Hospital Cambridge England
United Kingdom Essex County Hospital Colchester England
United Kingdom Ipswich Hospital Ipswich England
United Kingdom Leeds Cancer Centre at St. James's University Hospital Leeds England
United Kingdom Saint Bartholomew's Hospital London England
United Kingdom University College of London Hospitals London England
United Kingdom Norfolk and Norwich University Hospital Norwich England
United Kingdom Royal Marsden - Surrey Sutton England
United Kingdom Southend University Hospital NHS Foundation Trust Westcliff-On-Sea England

Sponsors (1)

Lead Sponsor Collaborator
Queen Mary University of London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pulmonary toxicity Yes
Secondary Response to treatment No
Secondary Progression-free survival No
Secondary Overall survival No
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