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Irinotecan Hydrochloride With or Without Alvocidib in Treating Patients With Advanced Stomach Cancer or Gastroesophageal Junction Cancer

2014-08-27 03:18:47 | BioPortfolio

Summary

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.

Description

OBJECTIVES:

Primary

- To examine the antitumor efficacy of irinotecan hydrochloride with vs without alvocidib in patients with p53 wild type advanced gastric or gastroesophageal junction adenocarcinoma.

Secondary

- 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.

Tertiary

- 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.

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Conditions

Adenocarcinoma of the Gastroesophageal Junction

Intervention

alvocidib, irinotecan hydrochloride

Location

Memorial Sloan-Kettering Cancer Center
New York
New York
United States
10065

Status

Recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:18:47-0400

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Medical and Biotech [MESH] Definitions

A lesion with cytological characteristics associated with invasive adenocarcinoma but the tumor cells are confined to the GLANDULAR EPITHELIAL CELLS of origin. Adenocarcinoma in situ of the CERVIX and the LUNG are the most common.

The physiologic or functional barrier to GASTROESOPHAGEAL REFLUX at the esophagogastric junction. Sphincteric muscles remain tonically contracted during the resting state and form the high-pressure zone separating the lumen of the ESOPHAGUS from that of the STOMACH. (Haubrich et al, Bockus Gastroenterology, 5th ed., pp399, 415)

An adenocarcinoma producing mucin in significant amounts. (From Dorland, 27th ed)

An adenocarcinoma of the thyroid gland, in which the cells are arranged in the form of follicles. (From Dorland, 27th ed)

An adenocarcinoma with a hard (Greek skirrhos, hard) structure owing to the formation of dense connective tissue in the stroma. (From Dorland, 27th ed)

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