Overview

This trial is active, not recruiting.

Conditions extragonadal germ cell tumor, teratoma, testicular germ cell tumor
Treatments bleomycin sulfate, filgrastim, cisplatin, etoposide, paclitaxel
Phase phase 2/phase 3
Sponsor European Organisation for Research and Treatment of Cancer - EORTC
Start date October 1998
Trial size 498 participants
Trial identifier NCT00003643, EORTC-30983

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Primary purpose treatment

Primary Outcomes

Measure
Failure-free survival as measured by Logrank
time frame:

Secondary Outcomes

Measure
Response to treatment as measured by normalized markers without residual viable cancer after CT scan or surgery
time frame:
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
time frame:
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
time frame:
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
time frame:
Quality of life as measured by Quality of Life Questionnaire Core 30 (QLQ-C30) at baseline, during treatment, and at years 1 and 2
time frame:

Eligibility Criteria

Male participants from 16 years up to 50 years old.

DISEASE CHARACTERISTICS: - Histologically proven germ cell cancer - Seminoma - Non-seminoma - Combined - Intermediate prognosis - Non-seminoma: - Testis/retroperitoneal primary - No non-pulmonary visceral metastases - Meets 1 of the following criteria: - Alpha-fetoprotein (AFP) 1,000- 10,000 IU/L - Human chorionic gonadotropin (hCG) 5,000-50,000 IU/L - Lactic dehydrogenase (LDH) 1.5 times-10 times upper limit of normal (ULN) - Seminoma: - Any primary site - Any LDH and HCG - AFP normal - Non-pulmonary visceral metastases present PATIENT CHARACTERISTICS: Age: - 16 to 50 Sex: - Male Performance status: - WHO 0-2 Life expectancy: - Not specified Hematopoietic: - WBC at least 3,000/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than 1.25 times ULN - AST no greater than 2 times ULN Renal: - Creatinine clearance at least 40 mL/min (unless due to obstructive uropathy which can be relieved by nephrostomy) Other: - No pre-existing neuropathy - No other malignancy except basal cell skin cancer - No other serious illness or medical conditions incompatible with the protocol PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior chemotherapy Endocrine therapy: - Not specified Radiotherapy: - Not specified Surgery: - Not specified

Additional Information

Official title Randomized Phase II/III Study of Taxol/Paclitaxel-BEP Versus BEP in Patients With Intermediate Prognosis Germ Cell Cancer
Description OBJECTIVES: Phase II - 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. Phase III - 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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2012.
Information provided to ClinicalTrials.gov by European Organisation for Research and Treatment of Cancer - EORTC.