Combination Chemotherapy and Pegfilgrastim in Treating Men With Metastatic Germ Cell Tumors

Phase 2

Completed

• Conditions: Extragonadal Germ Cell Tumor; Teratoma; Testicular Germ Cell Tumor

• Registration Number: NCT00453232
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust

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. Colony-stimulating factors, such as pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving combination chemotherapy together with pegfilgrastim may kill more tumor cells.

PURPOSE: This phase II trial is studying the side effects and how well giving combination chemotherapy together with pegfilgrastim works in treating men with metastatic germ cell tumors.

Detailed Description

OBJECTIVES:

Primary

* Determine the feasibility of accelerated treatment comprising bleomycin, etoposide, cisplatin, and pegfilgrastim in men with metastatic germ cell tumors.

* Determine the toxicity of this regimen (particularly with respect to renal, pulmonary, and neurological function) in these patients.

Secondary

* Determine the response rate in patients treated with this regimen.

* Determine the progression-free survival of patients treated with this regimen.

OUTLINE: This is a non-randomized, pilot study.

Patients receive etoposide IV on days 1-3, cisplatin IV on days 1 and 2, and bleomycin IV over 2 hours on days 2, 6, and 10. Patients also receive pegfilgrastim subcutaneously on day 4. Treatment repeats every 14 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 2 years.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Study Timeline

• Study Start: 2004-08
• Study First Submitted: 2007-03-27
• Study First Submitted QC: 2007-03-27
• Study First Posted: 2007-03-28
• Status Verified: 2007-08
• Primary Completion: 2008-12
• Study Completion: 2009-01
• Last Update Submitted: 2013-08-06
• Last Update Posted: 2013-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Toxicity
Feasibility

Secondary Outcome Measures

Name	Time	Method
Progression-free survival
Response rate

Trial Locations

Locations (7)

Edinburgh Cancer Centre at Western General Hospital; 🇬🇧 Edinburgh, Scotland, United Kingdom

Saint Bartholomew's Hospital; 🇬🇧 London, England, United Kingdom

Beatson West of Scotland Cancer Centre; 🇬🇧 Glasgow, Scotland, United Kingdom

Northern Centre for Cancer Treatment at Newcastle General Hospital; 🇬🇧 Newcastle-Upon-Tyne, England, United Kingdom

Addenbrooke's Hospital; 🇬🇧 Cambridge, England, United Kingdom

Leeds Cancer Centre at St. James's University Hospital; 🇬🇧 Leeds, England, United Kingdom

Churchill Hospital; 🇬🇧 Oxford, England, United Kingdom