Accelerated or Standard BEP Chemotherapy in Treating Patients with Intermediate or Poor-Risk Metastatic Germ Cell Tumors

Summary

Objectives

PRIMARY OBJECTIVE:
I. To compare the two treatment arms with respect to progression-free survival (disease progression or death).

SECONDARY OBJECTIVES:
I. To compare the two treatment arms with respect to:
Ia. Response following treatment completion (protocol-specific response criteria).
Ib. Adverse events (worst grade according to National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version [v]4.03).
Ic. Health-related quality of life (summary scales from Quality of Life Questionnaire [QLQ]-C30 & -Testicular Cancer [TC]-26).
Id. Treatment preference (proportion preferring each treatment arm).
Ie. Delivered dose-intensity of chemotherapy (relative to standard BEP).
If. Overall survival (death from any cause).

CORRELATIVE OBJECTIVES:
I. Determine associations between biomarkers to be specified and their correlations with clinical outcomes.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive bleomycin sulfate intravenously (IV) over 10 minutes on days 1, 8, and 15 or 2, 9, and 16, etoposide phosphate IV over 1-2 hours once daily (QD) on days 1-5, cisplatin IV over 1-3 hours QD on days 1-5, and pegfilgrastim subcutaneously (SC) on day 6 or filgrastim for a minimum of 5 days until post-nadir absolute neutrophil count >= 1.0 x 10^9/L. Cycles repeat every 21 days for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients receiving fewer than 8 doses of bleomycin sulfate due to pulmonary toxicity receive ifosfamide IV, mesna IV, etoposide phosphate IV, and cisplatin IV on days 1-5 and pegfilgrastim SC on day 6. Cycles repeat every 21 days for 12 weeks in the absence of disease progression or unacceptable toxicity.

ARM B: Patients receive bleomycin sulfate IV over 10 minutes on days 1 and 8 or 2 and 9, etoposide phosphate IV over 1-2 hours QD on days 1-5, cisplatin IV over 1-3 hours QD on days 1-5, and pegfilgrastim SC on day 6 or filgrastim for a minimum of 5 days until post-nadir absolute neutrophil count >= 1.0 x 10^9/L. Cycles repeat every 14 days for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients receiving fewer than 8 doses of bleomycin sulfate due to pulmonary toxicity receive ifosfamide IV, mesna IV, etoposide phosphate IV, and cisplatin IV on days 1-5 and pegfilgrastim SC on day 6. Cycles repeat every 21 days for 12 weeks in the absence of disease progression or unacceptable toxicity. After 12 weeks, patients then receive bleomycin sulfate IV over 60 minutes weekly for 4 doses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months, annually until disease progression, and then every 6 months after disease progression.