Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

OBJECTIVES:

- Compare the efficacy of standard cisplatin, etoposide, and ifosfamide (VIP) followed by sequential high-dose VIP and stem cell rescue versus bleomycin, etoposide, and cisplatin (BEP) in men with previously untreated poor-prognosis germ cell cancer.

- Compare the acute and late toxicities of these treatment regimens in this patient population.

- Compare these regimens in terms of failure-free survival, response rate, and overall survival in these patients.

- Evaluate the quality of life in these patients.

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.

- Arm I: Patients receive etoposide IV over 1 hour followed by cisplatin IV over 1 hour on days 1-5 and bleomycin IV over 30 minutes on days 2, 8, and 15. Treatment repeats every 3 weeks for 4 courses.

- Arm II: Patients receive 1 course of standard dose chemotherapy consisting of etoposide IV over 1 hour followed by cisplatin IV over 1 hour and ifosfamide IV over 1 hour on days 1-5. Peripheral blood stem cells (PBSC) are harvested around day 12-15. Patients also receive daily filgrastim (G-CSF) subcutaneously beginning on day 6 and continuing until PBSC collection is complete.

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. ;


Study Design

Allocation: Randomized, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00003941
Study type Interventional
Source European Organisation for Research and Treatment of Cancer - EORTC
Contact
Status Completed
Phase Phase 3
Start date April 1999

See also
  Status Clinical Trial Phase
Recruiting NCT05094804 - A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents Phase 1/Phase 2
Enrolling by invitation NCT00068003 - Harvesting Cells for Experimental Cancer Treatments
Recruiting NCT05798611 - Study of ART0380 in Patients With Biologically Selected Solid Tumors Phase 2
Not yet recruiting NCT04931420 - Study Comparing Standard of Care Chemotherapy With/ Without Sequential Cytoreductive Surgery for Patients With Metastatic Foregut Cancer and Undetectable Circulating Tumor-Deoxyribose Nucleic Acid Levels Phase 2
Recruiting NCT05566574 - A Study of RP-3500 in Combination With Standard Radiation Therapy in People With Solid Tumor Cancer Phase 1/Phase 2
Recruiting NCT05036681 - A Phase II Study of Futibatinib and Pembrolizumab in Metastatic Microsatellite Stable Endometrial Carcinoma Phase 2
Withdrawn NCT00005030 - SCH 66336 Before Surgery in Treating Patients With Colorectal Cancer That Has Metastasized to the Liver Phase 1
Recruiting NCT05525858 - KPMNG Study of MOlecular Profiling Guided Therapy Based on Genomic Alterations in Advanced Solid Tumors II
Recruiting NCT04085029 - Role of Ablative Radiotherapy in the Management of Metastatic Disease: A Patient Data Registry
Recruiting NCT06058988 - Trastuzumab Deruxtecan (T-DXd) for People With Brain Cancer Phase 2
Not yet recruiting NCT05981170 - Rurality Adapted Physical Activity Sport Health
Not yet recruiting NCT03058809 - Evaluation of Viatarâ„¢ Oncopheresis System in Removing CTC From Whole Blood Phase 1/Phase 2
Completed NCT02529553 - A Study of LY3076226 in Participants With Advanced or Metastatic Cancer Phase 1
Terminated NCT01929941 - An Open-Label Study of a Novel JAK-inhibitor, INCB047986, Given in Patients With Advanced Malignancies Phase 1
Terminated NCT00918645 - Calcium-41 (41Ca) Chloride Aqueous Solution in Diagnosing Patients With Prostate Cancer and Bone Metastasis N/A
Completed NCT01302808 - Romidepsin and Erlotinib Hydrochloride in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer Phase 1
Completed NCT00795678 - Chemotherapeutic Agents in Brain/Breast N/A
Withdrawn NCT00769990 - Genistein in Treating Patients Undergoing External-Beam Radiation Therapy for Bone Metastases Phase 1/Phase 2
Completed NCT00557102 - Cetuximab and Combination Chemotherapy as First-Line Therapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver and/or Lung Phase 2
Recruiting NCT00398437 - Magnetic Resonance Imaging for the Early Detection of CNS Metastases in Women With Stage IV Breast Cancer N/A