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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00324298
First received: May 10, 2006
Last updated: August 9, 2013
Last verified: January 2007
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Pulmonary toxicity [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Response to treatment [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]

Estimated Enrollment: 210
Study Start Date: July 2003
Study Completion Date: March 2011
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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00324298

Locations
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
University College of London Hospitals
London, England, United Kingdom, WIT 3AA
Saint Bartholomew's Hospital
London, England, United Kingdom, EC1A 7BE
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
Investigators
Study Chair: Jonathan Shamash, MD, FRCP St. Bartholomew's Hospital
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00324298     History of Changes
Other Study ID Numbers: BARTS-TE3, CDR0000472976, EU-20608, ISRCTN08648791
Study First Received: May 10, 2006
Last Updated: August 9, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
drug/agent toxicity by tissue/organ
stage III malignant testicular germ cell tumor

Additional relevant MeSH terms:
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Bleomycin
Etoposide phosphate
Cisplatin
Etoposide
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on July 28, 2014