Combination Chemotherapy and Pegfilgrastim in Treating Men With Metastatic Germ Cell Tumors
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|ClinicalTrials.gov Identifier: NCT00453232|
Recruitment Status : Completed
First Posted : March 28, 2007
Last Update Posted : August 7, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Extragonadal Germ Cell Tumor Teratoma Testicular Germ Cell Tumor||Biological: bleomycin sulfate Biological: pegfilgrastim Drug: cisplatin Drug: etoposide||Phase 2|
- 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.
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Official Title:||Accelerated BEP Chemotherapy for Intermediate and High Risk Metastatic Germ Cell Tumor|
|Study Start Date :||August 2004|
|Actual Primary Completion Date :||December 2008|
|Actual Study Completion Date :||January 2009|
- Response rate
- Progression-free survival
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 ClinicalTrials.gov identifier (NCT number): NCT00453232
|Cambridge, England, United Kingdom, CB2 2QQ|
|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|
|Northern Centre for Cancer Treatment at Newcastle General Hospital|
|Newcastle-Upon-Tyne, England, United Kingdom, NE4 6BE|
|Oxford, England, United Kingdom, OX3 7LJ|
|Edinburgh Cancer Centre at Western General Hospital|
|Edinburgh, Scotland, United Kingdom, EH4 2XU|
|Beatson West of Scotland Cancer Centre|
|Glasgow, Scotland, United Kingdom, G11 6NT|
|Study Chair:||Michael Williams, MD||Cambridge University Hospitals NHS Foundation Trust|