COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

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. Identifier: NCT00324298
Recruitment Status : Completed
First Posted : May 11, 2006
Last Update Posted : August 12, 2013
Information provided by:
National Cancer Institute (NCI)

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:



  • 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.


  • 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : July 2003
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Pulmonary toxicity

Secondary Outcome Measures :
  1. Response to treatment
  2. Progression-free survival
  3. Overall survival

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • Diagnosis of metastatic germ cell cancer of the testes

    • Good-prognosis disease
  • Eligible for treatment with bleomycin, etoposide, and cisplatin


  • 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


  • No prior chemotherapy or radiotherapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00324298

Layout table for location information
United Kingdom
Basildon University Hospital
Basildon, England, United Kingdom, SS16 5NL
Addenbrooke's Hospital
Cambridge, England, United Kingdom, CB2 2QQ
Essex County Hospital
Colchester, England, United Kingdom, C03 3NB
Ipswich Hospital
Ipswich, England, United Kingdom, IP4 5PD
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom, LS9 7TF
Saint Bartholomew's Hospital
London, England, United Kingdom, EC1A 7BE
University College of London Hospitals
London, England, United Kingdom, WIT 3AA
Norfolk and Norwich University Hospital
Norwich, England, United Kingdom, NR4 7UY
Royal Marsden - Surrey
Sutton, England, United Kingdom, SM2 5PT
Southend University Hospital NHS Foundation Trust
Westcliff-On-Sea, England, United Kingdom, SS0 0RY
Sponsors and Collaborators
Queen Mary University of London
Layout table for investigator information
Study Chair: Jonathan Shamash, MD, FRCP St. Bartholomew's Hospital
Layout table for additonal information Identifier: NCT00324298    
Other Study ID Numbers: BARTS-TE3
CDR0000472976 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: May 11, 2006    Key Record Dates
Last Update Posted: August 12, 2013
Last Verified: January 2007
Keywords provided by National Cancer Institute (NCI):
drug/agent toxicity by tissue/organ
stage III malignant testicular germ cell tumor
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms, Germ Cell and Embryonal
Drug-Related Side Effects and Adverse Reactions
Neoplasms by Histologic Type
Chemically-Induced Disorders
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic