Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Combination Chemotherapy in Treating Men With Germ Cell Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III, Phase II	Treatment	Closed	16 to 50	Other	EORTC-30983 NCT00003643

Objectives

Phase II

1. 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).
2. Define the toxicity profile of T-BEP in these patients.

Phase III

1. Compare the disease-free survival of patients treated with these regimens.
2. Compare the complete response rates and overall survival of patients treated with these regimens.
3. Compare symptoms and aspects of quality of life at baseline and after treatment in patients treated with these regimens.
4. Compare the acute and intermediate (1-2 years) side effects of these regimens in these patients.

Entry 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

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• Not specified

Patient Characteristics:

Age:

• 16 to 50

Sex:

• Male

Performance status:

• WHO 0-2

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 3,000/mm³
• Platelet count at least 100,000/mm³

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

Expected Enrollment

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.

Outcomes

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

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.

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Ronald De Wit, MD, PhD, Study coordinator		Ph: 31-10-439-1760 Email: r.dewit@erasmusmc.nl

Registry Information
Official Title		Randomized Phase II/III Study of Taxol/Paclitaxel-BEP Versus BEP in Patients with Intermediate Prognosis Germ Cell Cancer
Trial Start Date		1998-10-14
Registered in ClinicalTrials.gov		NCT00003643
Date Submitted to PDQ		1998-10-27
Information Last Verified		2009-06-14

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