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

Alternate Title

Combination Chemotherapy With or Without Peripheral Stem Cell Transplant in Treating Men With Previously Untreated Germ Cell Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	16 to 50	Other	EORTC-30974 NCT00003941

Objectives

1. 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.
2. Compare the acute and late toxicities of these treatment regimens in this patient population.
3. Compare these regimens in terms of failure-free survival, response rate, and overall survival in these patients.
4. Evaluate the quality of life in these patients.

Entry Criteria

Disease Characteristics:

• Histologically proven germ cell cancer
  • Nonseminoma

    OR

  • Combined seminoma and nonseminoma
• Poor prognosis (nonseminoma):
  • Testis/retroperitoneal primary

    AND

  • One of the following poor tumor markers
    • AFP greater than 10,000 iu/L
    • HCG greater than 50,000 iu/L
    • LDH greater than 10 times upper limit of normal

    OR

  • Nonpulmonary visceral metastases (i.e., liver, bone, or brain)

    OR

  • Mediastinal primary

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• Concurrent radiotherapy for brain metastases allowed

Surgery:

• Concurrent surgery for brain metastases allowed

Patient Characteristics:

Age:

• 16 to 50

Sex:

• Male

Performance status:

• WHO 0-3

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 upper limit of normal (ULN)
• AST no greater than 2 times ULN

Renal:

• Creatinine clearance at least 60 mL/min (unless due to obstructive uropathy correctable by nephrostomy)

Other:

• No other malignancy except basal cell skin cancer
• No neuropathy
• No other serious illness or medical condition
• No psychological, familial, sociological, or geographical condition that would prevent compliance

Expected Enrollment

A total of 222 patients (111 per treatment arm) will be accrued for this study within 2 years.

Outcomes

Failure-free survival as measured by Logrank at 1 year

Complete response as measured by negative tumor markers and no residual masses or viable cancer cells at the end of CT scan or debulking surgery
Overall survival as measured by Logrank at 2 years
Quality of life as measured by Quality of Life Questionnaire-Core 30 (QLQ-C30) v3.0 at baseline, at month 6, and at year 2
Toxicity as measured by NCI-CTC v2.0 after each course, every 6 months up to year 5, and yearly

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.

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Gedske Daugaard, MD, DMSc, Study coordinator		Ph: 45-3545-4677 Email: gedske.daugaard@regionh.dk

Registry Information
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
Trial Start Date		1999-04-28
Registered in ClinicalTrials.gov		NCT00003941
Date Submitted to PDQ		1999-05-18
Information Last Verified		2006-11-19

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