NCT00183898

Study of Oxaliplatin and Xeloda and Cetuximab as First Line Treatment for Metastatic or Unresectable Gastric or Gastroesophageal Junction Cancer

Status unknown Phase 2 Last updated 16 May 2019

What this trial tests

Phase 2 trial testing oxaliplatin, capecitabine in Gastric Cancer in 75 participants. Status unknown.

Timeline

28 December 2004

Primary endpoint
4 February 2013

28 December 2019

Quick facts

Lead sponsor	University of Southern California
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	75
Start date	28 December 2004
Primary completion	4 February 2013
Estimated completion	28 December 2019
Sites	1 location across United States

Drugs / interventions tested

• oxaliplatin, capecitabine

Conditions studied

• Gastric Cancer — all drugs for Gastric Cancer →
• Esophageal Cancer — all drugs for Esophageal Cancer →

Sponsor

University of Southern California

Who can join

18 and older, female only, with Gastric Cancer or Esophageal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. New therapeutic options opened by the molecular classification of gastric cancer.
   Chivu-Economescu M, Matei L, Necula LG, Dragu DL, et al · · 2018 · cited 33× · PMID 29760539 · DOI 10.3748/wjg.v24.i18.1942