Study of Erlotinib and Chemotherapy for Unresectable or Metastatic Cancer of the Esophagus and Ga… (NCT00591123) | Clinical Trial Compass
CompletedPhase 2
Study of Erlotinib and Chemotherapy for Unresectable or Metastatic Cancer of the Esophagus and Gastric Cardia
United States38 participantsStarted 2007-12
Plain-language summary
In this study, Erlotinib and 5-Fluorouracil (5-FU), Leucovorin and Oxaliplatin (a regimen known also as FOLFOX-6) will be the chemotherapy study drugs. The main purpose of this study is to test the safety and effectiveness of this combination of chemotherapy drugs and to see how they affect your cancer.
Another purpose of this study is to examine samples from your blood and tumor. This research will be done to better understand how subjects respond to treatment. Specifically, researchers will look at the way your genes and proteins respond to drugs like those used in this study.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Metastatic or unresectable adenocarcinoma of the upper gastrointestinal tract that can be measured in at least one dimension according to RECIST criteria by CT or MRI
✓. Gastric adenocarcinomas may be included if the primary tumor arises within 5 cm of the anatomic gastro-esophageal junction (distal esophagus) or from the gastric cardia as indicated by either endoscope or imaging.
✓. Previously untreated with chemotherapeutic agents for unresectable or metastatic disease.
✓. Adjuvant chemotherapy and/or radiotherapy are allowed as long as no oxaliplatin was used in the past 12 months.
✓. ECOG performance status 0 or 1
✓. Age \> 18 years old.
✓. Life expectancy greater than 6 months.
✓. Peripheral neuropathy: must be \< grade 1
Exclusion criteria
✕. Patients with known hypersensitivity to any components of oxaliplatin, leucovorin, 5-fluorouracil (or other fluoropyrimidines) or erlotinib.
What they're measuring
1
Overall Response Rate of Previously-untreated Patients With Unresectable or Metastatic Adenocarcinomas of the Upper Gastrointestinal Tract When Treated With the Combination of 5-fluorouracil, Leucovorin, Oxaliplatin, and Erlotinib.
Timeframe: 3.5 years
Trial details
NCT IDNCT00591123
SponsorTranslational Oncology Research International