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RATIONALE: Drugs used in chemotherapy, such as irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Alvocidib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving irinotecan hydrochloride together with alvocidib may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying how well giving irinotecan hydrochloride with or without alvocidib works in treating patients with advanced stomach cancer or gastroesophageal junction cancer.
- To examine the antitumor efficacy of irinotecan hydrochloride with vs without alvocidib in patients with p53 wild type advanced gastric or gastroesophageal junction adenocarcinoma.
- To evaluate the safety and toxicity of these regimens in these patients.
- To examine other measures of antitumor activity of these regimens, including response rate (in patients with measurable disease) and overall survival.
- To evaluate pre- and post-treatment tumor biopsy samples for p21 and Rad51 expression in patients who agree to undergo tumor biopsies (Memorial Sloan-Kettering Cancer Center [MSKCC] only).
- To explore the response to these regimens by DNA microarray technology using pre- and post-treatment tumor biopsy samples (MSKCC only).
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive irinotecan hydrochloride IV over 30 minutes and alvocidib IV over 1 hour on days 1 and 8.
- Arm II: Patients receive irinotecan hydrochloride IV over 30 minutes on days 1 and 8.
In both arms, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Tumor tissue samples may be collected pre- and post-treatment for correlative laboratory studies.
After completion of study treatment, patients are followed up every 3 months for 1 year.
Allocation: Randomized, Primary Purpose: Treatment
Adenocarcinoma of the Gastroesophageal Junction
alvocidib, irinotecan hydrochloride
Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:18:47-0400
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