Combination Chemotherapy in Treating Men With Germ Cell Cancer
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|ClinicalTrials.gov Identifier: NCT00003643|
Recruitment Status : Unknown
Verified March 2012 by European Organisation for Research and Treatment of Cancer - EORTC.
Recruitment status was: Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : March 6, 2012
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of combination chemotherapy may be more effective for germ cell cancer.
PURPOSE: This randomized phase II/III trial is studying two different regimens of combination chemotherapy and comparing how well they work in treating men with germ cell cancer.
|Condition or disease||Intervention/treatment||Phase|
|Extragonadal Germ Cell Tumor Teratoma Testicular Germ Cell Tumor||Biological: bleomycin sulfate Biological: filgrastim Drug: cisplatin Drug: etoposide Drug: paclitaxel||Phase 2 Phase 3|
- Compare the complete response rates in men with intermediate prognosis germ cell cancer treated with bleomycin, cisplatin, and etoposide (BEP) vs bleomycin, cisplatin, etoposide, and paclitaxel (T-BEP).
- Define the toxicity profile of T-BEP in these patients.
- Compare the disease-free survival of patients treated with these regimens.
- Compare the complete response rates and overall survival of patients treated with these regimens.
- Compare symptoms and aspects of quality of life at baseline and after treatment in patients treated with these regimens.
- Compare the acute and intermediate (1-2 years) side effects of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to histology (seminoma vs non-seminoma) and hospital. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive cisplatin IV and etoposide IV on days 1-5 and bleomycin IV on days 1, 8, and 15.
- Arm II: Patients receive cisplatin, etoposide, and bleomycin as in arm I and paclitaxel IV over 3 hours on day 1. Patients also receive filgrastim (G-CSF) subcutaneously on days 6-15.
In both arms, treatment repeats every 3 weeks for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed before treatment randomization and at 1 and 2 years after randomization.
Patients are followed monthly for 1 year, every 2 months for 1 year, every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 84-164 patients (42-82 per treatment arm) will be accrued for the phase II study. A total of 498 patients (249 per treatment arm) will be accrued for the phase III study. Accrual will be completed within 4 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||498 participants|
|Official Title:||Randomized Phase II/III Study of Taxol/Paclitaxel-BEP Versus BEP in Patients With Intermediate Prognosis Germ Cell Cancer|
|Study Start Date :||October 1998|
- Failure-free survival as measured by Logrank
- Response to treatment as measured by normalized markers without residual viable cancer after CT scan or surgery
- Overall survival as measured by Logrank at end of each course, at 6 weeks after completion of study treatment, every 6 months up to year 5, and then annually thereafter
- Disease-free survival as measured by Logrank at end of each course, at 6 weeks after completion of study treatment, every 6 months up to year 5, and then annually thereafter
- Toxicity as measured by NCI-CTC v2.0 at end of each course, at 6 weeks after completion of study treatment, every 6 months up to year 5, and then annually thereafter
- Quality of life as measured by Quality of Life Questionnaire Core 30 (QLQ-C30) at baseline, during treatment, and at years 1 and 2
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): NCT00003643
|Study Chair:||Ronald De Wit, MD, PhD||Daniel Den Hoed Cancer Center at Erasmus Medical Center|