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Sponsored by: |
European Organization for Research and Treatment of Cancer |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003941 |
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. Peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy and kill more cancer cells. It is not yet known whether chemotherapy and peripheral stem cell transplant is more effective than chemotherapy alone.
PURPOSE: This randomized phase III trial is studying how well combination chemotherapy works when given with peripheral stem cell transplant and how it compares with combination chemotherapy alone in treating men with previously untreated germ cell cancer.
Condition | Intervention | Phase |
Brain and Central Nervous System Tumors Mediastinal Cancer Metastatic Cancer Testicular Germ Cell Tumor |
Drug: bleomycin Drug: cisplatin Drug: etoposide Drug: filgrastim Drug: ifosfamide Procedure: bone marrow ablation with stem cell support Procedure: peripheral blood stem cell transplantation |
Phase III |
MedlinePlus related topics: | Cancer |
ChemIDplus related topics: | Ifosfamide Filgrastim Etoposide Cisplatin Etoposide phosphate Bleomycin Bleomycin sulfate |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Randomized Phase III Study of Sequential High-Dose Cisplatinum/Etoposide/Ifosfamide Plus Stem Cell Support Versus BEP in Patients With Poor Prognosis Germ Cell Cancer |
Estimated Enrollment: | 222 |
Study Start Date: | April 1999 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, primary mediastinal germ cell tumor (yes vs no), and nonpulmonary visceral metastases (liver vs bone vs brain). Patients are randomized to one of two treatment arms.
After day 21, patients receive high-dose chemotherapy consisting of etoposide IV over 1 hour followed by cisplatin IV over 1 hour, and ifosfamide IV over 1 hour on days -6 through -2. PBSCs are infused on day 0. Patients receive daily G-CSF subcutaneously beginning on day 1 and continuing through day 19 or until blood counts have recovered. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed before chemotherapy, at 6 months, and at 2 years after treatment.
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 annually thereafter.
PROJECTED ACCRUAL: A total of 222 patients (111 per treatment arm) will be accrued for this study within 2 years.
Ages Eligible for Study: | 16 Years to 50 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven germ cell cancer
Poor prognosis (nonseminoma):
One of the following poor tumor markers
PATIENT CHARACTERISTICS:
Age:
Sex:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Show 37 Study Locations |
European Organization for Research and Treatment of Cancer |
Investigator: | Gedske Daugaard, MD, DMSc | Rigshospitalet, Denmark |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000067134, EORTC-30974 |
First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003941 |
Health Authority: | United States: Federal Government |
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