Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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.

Further Study Information

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.

Eligibility Criteria

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

Trial Contact Information

Trial Lead Organizations/Sponsors

European Organization for Research and Treatment of Cancer

Ronald De Wit

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00003643
Information obtained from ClinicalTrials.gov on December 21, 2011

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