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

Tracking Information
First Submitted Date  ICMJE May 10, 2006
First Posted Date  ICMJE May 11, 2006
Last Update Posted Date August 12, 2013
Study Start Date  ICMJE July 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: November 8, 2006)
Pulmonary toxicity
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 8, 2006)
  • Response to treatment
  • Progression-free survival
  • Overall survival
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bleomycin, Etoposide, and Cisplatin in Treating Patients With Metastatic Germ Cell Cancer of the Testicles
Official Title  ICMJE 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
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.

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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Primary Purpose: Treatment
Condition  ICMJE
  • Drug/Agent Toxicity by Tissue/Organ
  • Testicular Germ Cell Tumor
Intervention  ICMJE
  • Biological: bleomycin sulfate
  • Drug: cisplatin
  • Drug: etoposide
  • Procedure: management of therapy complications
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: November 8, 2006)
210
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE March 2011
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00324298
Other Study ID Numbers  ICMJE BARTS-TE3
CDR0000472976 ( Registry Identifier: PDQ (Physician Data Query) )
EU-20608
ISRCTN08648791
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Queen Mary University of London
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Jonathan Shamash, MD, FRCP St. Bartholomew's Hospital
PRS Account National Cancer Institute (NCI)
Verification Date January 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP