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Anti-metabolites

Oxaliplatin and Capecitabine for Stomach Cancer

Phase 2
Waitlist Available
Led By Syma Iqbal, M.D.
Research Sponsored by University of Southern California
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 2 cyclec
Awards & highlights

Study Summary

This study is for people with advanced gastric or gastroesophageal cancer. This study is being done to find out how long it takes tumors to grow after patients take the drugs capecitabine, oxaliplatin and cetuximab. Capecitabine (also called Xeloda) is a drug that has been approved by the Food and Drug Administration (FDA). Capecitabine has been approved for treatment of cancer of the colon and rectum. Oxaliplatin is another drug approved by the FDA. Oxaliplatin is also approved for treatment of cancer of the colon and rectum. Cetuximab is also a drug approved by the FDA for the treatment of cancer of the colon and rectum, as well as cancer of the head and neck. Capecitabine, oxaliplatin and cetuximab are not approved for gastric or gastroesophageal cancer. They are considered experimental drugs for this study. The purpose of this study is to see how long it takes patients' tumors to progress when they are taking oxaliplatin and capecitabine. Another purpose is to see how many tumors respond to this drug combination. The investigators also want to see how long people live when taking these drugs. The side effects of this drug combination will also be evaluated. This study will also measure the levels of certain genes (the cell's blueprint) in tumors. These genes affect how peoples' bodies react to the cancer drugs. Genes will also be measured in the blood. The investigators want to see how these genes can predict response to these study drugs.

Eligible Conditions
  • Stomach Cancer
  • Esophageal Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 2 cycles
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 2 cycles for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To determine the proportion of patients, with advanced gastric or gastroesophageal junction cancer treated with a combination of capecitabine and oxaliplatin, that have progressive disease within four months of the start of treatment
Secondary outcome measures
To assess the toxicity of this regimen
To determine the time to progression, overall response rate and overall survival in patients with advanced gastric or gastroesophageal junction cancer treated with a combination of capecitabine and oxaliplatin

Trial Design

1Treatment groups
Experimental Treatment
Group I: Oxaliplatin and CapecitabineExperimental Treatment1 Intervention
Oxaliplatin given every 21 days Capecitabine given daily x 14 days every 21 days

Find a Location

Who is running the clinical trial?

Roche Global DevelopmentOTHER
4 Previous Clinical Trials
782 Total Patients Enrolled
University of Southern CaliforniaLead Sponsor
906 Previous Clinical Trials
1,596,213 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,639 Previous Clinical Trials
4,128,957 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~4 spots leftby Apr 2025