Irinotecan, Cisplatin, and Bevacizumab in Treating Patients With Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

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

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00084604
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 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

  • irinotecan hydrochloride — DRUG
    Given IV
  • bevacizumab — BIOLOGICAL
    Given IV
  • cisplatin — DRUG
    Given IV
  • computed tomography — PROCEDURE
    Correlative studies
  • laboratory biomarker analysis — OTHER
    Correlative studies

Study Details

This phase II trial is studying how well giving irinotecan and cisplatin together with bevacizumab works in treating patients with unresectable or metastatic gastric (stomach) or gastroesophageal junction adenocarcinoma (cancer). Drugs used in chemotherapy, such as irinotecan and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as bevacizumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Giving chemotherapy together with a monoclonal antibody may kill more tumor cells.

Key Dates

Start date
Apr 30, 2004
Status verified
Jun 2013
Primary completion
Oct 31, 2007

Study Design

Enrollment
47 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (bevacizumab, cisplatin, irinotecan)
    Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive cisplatin IV over 30 minutes followed by irinotecan IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Time to progression, evaluated using RECIST [ Time Frame: Up to 1 year ]

Locations (1)

FacilityCityStateZIPSite coordinators
Memorial Sloan-Kettering Cancer CenterNew YorkNew York10065-

Find similar trials in New York, NY

By research site
Memorial Sloan-Kettering Cancer Center· New York, NY

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