A Multicenter Random Assignment Phase II Study of Irinotecan and Alvocidib (Flavopiridol) Versus Irinotecan Alone for Patients With p53 Wild Type Gastric Adenocarcinoma
I. To examine the antitumor efficacy of irinotecan (irinotecan hydrochloride) followed by
flavopiridol (alvocidib) (Arm A) and of irinotecan alone (Arm B) in patients with advanced
gastric/ gastroesophageal junction (GEJ) adenocarcinoma wild type for p53.
I. To evaluate the safety and toxicity of both study arms in patients with advanced
II. To examine other measures of antitumor activity in both study arms, including response
rate (in patients with measurable disease) and overall survival.
I. To evaluate pre- and post-treatment tumor biopsies for p21 and RAD51 homolog (S.
cerevisiae) (Rad51) expression in patients who agree to tumor biopsies (Memorial
Sloan-Kettering Cancer Center [MSKCC] and Weill-Cornell only).
II. To explore the response to irinotecan and flavopiridol and to irinotecan alone by
deoxyribonucleic acid (DNA) microarray technology on pre- and post-treatment tumor biopsies
(MSKCC and Weill-Cornell only).
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM A: Patients receive irinotecan hydrochloride intravenously (IV) over 30 minutes and
alvocidib IV over 1 hour on days 1 and 8. Courses repeat every 21 days in the absence of
disease progression or unacceptable toxicity.
ARM B: Patients receive irinotecan hydrochloride as in Arm A. Courses repeat every 21 days
in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 1 year.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Progression-free survival (PFS) according to Response Evaluation Criteria in Solid Tumors (RECIST)
Up to 3 months
Memorial Sloan-Kettering Cancer Center at Saint Claires
United States: Food and Drug Administration
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