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

August 9, 2013 updated by: Queen Mary University of London

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

210

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Pulmonary toxicity

Secondary Outcome Measures

Outcome Measure
Progression-free survival
Overall survival
Response to treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen Mary University of London

Investigators

  • Study Chair: Jonathan Shamash, MD, FRCP, St. Bartholomew's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

May 10, 2006

First Submitted That Met QC Criteria

May 10, 2006

First Posted (Estimate)

May 11, 2006

Study Record Updates

Last Update Posted (Estimate)

August 12, 2013

Last Update Submitted That Met QC Criteria

August 9, 2013

Last Verified

January 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BARTS-TE3
  • CDR0000472976 (Registry Identifier: PDQ (Physician Data Query))
  • EU-20608
  • ISRCTN08648791

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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