Irinotecan Hydrochloride With or Without Alvocidib in Treating Patients With Advanced Stomach or Gastroesophageal Junction Cancer That Cannot Be Removed By Surgery

Conditions

• Adenocarcinoma of the Gastroesophageal Junction
• Diffuse Adenocarcinoma of the Stomach
• Intestinal Adenocarcinoma of the Stomach
• Mixed Adenocarcinoma of the Stomach
• Recurrent Gastric Cancer
• Stage IIIA Gastric Cancer
• Stage IIIB Gastric Cancer
• Stage IIIC Gastric Cancer
• Stage IV Gastric Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• alvocidib — DRUG
  Given IV
• irinotecan hydrochloride — DRUG
  Given IV
• laboratory biomarker analysis — OTHER
  Correlative studies

Study Details

This randomized phase II trial studies how well giving irinotecan hydrochloride with or without alvocidib works in treating patients with advanced stomach or gastroesophageal junction cancer that cannot be removed by surgery. 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. It is not yet known whether irinotecan hydrochloride is more effective with or without alvocidib.

Key Dates

Start date

Sep 30, 2009

Status verified

Dec 2013

Primary completion

Feb 29, 2012

Completion

Apr 30, 2014

Study Design

Enrollment

19 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A (irinotecan hydrochloride, alvocidib)
  Patients receive irinotecan hydrochloride 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.
• Active Comparator: Arm B (irinotecan hydrochloride)
  Patients receive irinotecan hydrochloride as in Arm A. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Overall Response Rate [ Time Frame: From the start of treatment for up to 3 months ]

Locations (5)

Find similar trials in Duarte, CA

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