A Non-Randomized Phase 2 Study of Alvocidib (Flavopiridol) Plus Oxaliplatin With or Without 5-FU and Leucovorin for Relapsed or Refractory Germ-Cell Tumors
I. To evaluate the antitumor efficacy of the combination of flavopiridol and oxaliplatin
with or without 5-FU and leucovorin in patients with relapsed or refractory GCT. The
necessity of 5-FU and leucovorin to the combination will also be indirectly tested in this
I. To further evaluate the safety of flavopiridol in combination with oxaliplatin with or
without 5-fluorouracil and leucovorin in patients with refractory or relapsed GCT.
II. To evaluate the time to tumor response (TTR) and progression-free survival for patients
with refractory or relapsed GCT treated with flavopiridol in combination with oxaliplatin
with or without 5-fluorouracil and leucovorin.
III. To explore the association between treatment response and p21, p53 and apoptotic
OUTLINE: Patients are initially enrolled in part A (closed to accrual as of 11/15/2010).
Depending on response to treatment, additional patients may be enrolled in part B.
PART A (alvocidib and oxaliplatin) (closed to accrual as of 11/15/2010): Patients receive
alvocidib IV over 1 hour and oxaliplatin IV over 2 hours on days 1, 15, and 29. Courses
repeat every 42 days in the absence of disease progression or unacceptable toxicity.
PART B (alvocidib and FOLFOX): Patients receive alvocidib IV over 1 hour, oxaliplatin IV
over 2 hours, and leucovorin calcium IV over 2 hours followed by fluorouracil IV
continuously over 48 hours on days 1, 15, and 29. Courses repeat every 42 days in the
absence of disease progression or unacceptable toxicity. Tumor tissue samples may be
collected periodically for further laboratory analysis.
After completion of study treatment, patients are followed up every 4-8 weeks.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response rate defined as the ratio of the number of patients who achieve a CR or PR divided by the number of evaluable patients, as assessed by RECIST criteria
Evaluable patients are those patients who are able to complete at least one cycle of therapy or have progressed any time during therapy.
Within 3 courses of treatment
Memorial Sloan-Kettering Cancer Center
United States: Food and Drug Administration
|Memorial Sloan Kettering Cancer Center||New York, New York 10021|
|Mayo Clinic||Rochester, Minnesota 55905|
|City of Hope Medical Center||Duarte, California 91010|
|University of Pittsburgh||Pittsburgh, Pennsylvania 15261|
|Tower Cancer Research Foundation||Beverly Hills, California 90211|
|UC Davis Comprehensive Cancer Center||Sacramento, California 95817|
|University of Chicago Comprehensive Cancer Center||Chicago, Illinois 60637-1470|
|University of Southern California||Los Angeles, California 90033|
|University of Wisconsin Cancer Center Riverview||Wisconsin Rapids, Wisconsin 54494|