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

NCT00324298 | Completed Phase 3

• 4 other identifiers: BARTS-TE3CDR0000472976EU-20608ISRCTN08648791
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 10

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.

Conditions

Drug/Agent Toxicity by Tissue/Organ; Testicular Germ Cell Tumor

Keywords

drug/agent toxicity by tissue/organ; stage III malignant testicular germ cell tumor

Outcome Measures

Primary Outcomes (1)

• Pulmonary toxicity

Secondary Outcomes (3)

• Response to treatment

• Progression-free survival

• Overall survival

Interventions

bleomycin sulfate BIOLOGICAL

cisplatin DRUG

etoposide DRUG

management of therapy complications PROCEDURE

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Queen Mary University of London: lead

Study Sites (10)

Basildon University Hospital

Basildon, England, SS16 5NL, United Kingdom

Location

Addenbrooke's Hospital

Cambridge, England, CB2 2QQ, United Kingdom

Location

Essex County Hospital

Colchester, England, C03 3NB, United Kingdom

Location

Ipswich Hospital

Ipswich, England, IP4 5PD, United Kingdom

Location

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, LS9 7TF, United Kingdom

Location

Saint Bartholomew's Hospital

London, England, EC1A 7BE, United Kingdom

Location

University College of London Hospitals

London, England, WIT 3AA, United Kingdom

Location

Norfolk and Norwich University Hospital

Norwich, England, NR4 7UY, United Kingdom

Location

Royal Marsden - Surrey

Sutton, England, SM2 5PT, United Kingdom

Location

Southend University Hospital NHS Foundation Trust

Westcliff-on-Sea, England, SS0 0RY, United Kingdom

Location

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions; Testicular Germ Cell Tumor; Testicular Neoplasms

Interventions

Bleomycin; Cisplatin; Etoposide

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Endocrine System Diseases; Testicular Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides

Study Officials

• Jonathan Shamash, MD, FRCP

  St. Bartholomew's Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 10, 2006
• First Posted: May 11, 2006
• Study Start: July 1, 2003
• Study Completion: March 1, 2011
• Last Updated: August 12, 2013

Record last verified: 2007-01

Locations

GB (10)