Bortezomib With or Without Irinotecan in Treating Patients With Cancer of the Gastroesophageal Junction or Stomach

Part of paid clinical trials in The Bronx, New York.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00061932
Phase
PHASE2
Status
Completed

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 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

  • bortezomib — DRUG
    Given IV
  • irinotecan — DRUG
    Given IV

Study Details

This phase II trial is studying how well bortezomib with or without irinotecan works in treating patients with gastroesophageal junction or stomach cancer that can not be removed by surgery. Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy such as irinotecan use different ways to stop tumor cells from dividing so they stop growing or die. Combining bortezomib with irinotecan may kill more tumor cells.

Key Dates

Start date
Apr 30, 2003
Status verified
Jan 2021
Primary completion
Dec 31, 2009
Completion
Nov 30, 2013

Study Design

Enrollment
41 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Stratum 1 (previously untreated)
    Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan IV over 90 minutes on days 1 and 8.
  • Experimental: Stratum 2 (previously treated)
    (closed to accrual as of 9/19/2006): Patients receive bortezomib as in stratum 1.

Primary Outcome Measure

True Response Rate Evaluated for the Combination of Irinotecan and PS341 by Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Up to 6 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Montefiore Medical CenterThe BronxNew York10467-2490-

Find similar trials in The Bronx, NY

By research site
Montefiore Medical Center· The Bronx, NY

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