5222S-12: S1201 esophageal, gastric, GEJ

SWOG 1201: A Randomized Phase II Pilot Study Prospectively Evaluating Treatment for Patients Based on ERCC1 (Excision Repair Cross-Complementing 1) for Advanced/Metastatic Esophageal, Gastric, or Gastroesophageal Junction (GEJ) Cancer

Type of Study
Cancer (Oncology) - Esophageal, Cancer (Oncology) - Gastroesophageal Junction, Cancer (Oncology) - Stomach
Location
Swedish Cancer Institute
Short Description

Purpose: This randomized phase II trial studies how well oxaliplatin, leucovorin calcium, and fluorouracil work compared to irinotecan hydrochloride and docetaxel in treating patients with esophageal cancer, gastric cancer, or gastroesophageal junction cancer.

Status
Open to Enrollment
Principal Investigator
Gary Goodman, M.D.
Eligibility Notes
  • Must have unresectable advanced or metastatic histologically or cytologically confirmed adenocarcinoma of the esophagus, stomach, or gastroesophageal junction (GEJ); patients must not have received treatment for metastatic or unresectable disease
  • Patients who have had HER-2 expression testing prior to patient consent to this study must be HER-2 negative; if HER-2 expression has not been tested prior to patient consent to this study, the specimen submitted for ERCC-1 expression will also be tested for HER-2 expression; if the specimen is HER-2 positive (or if HER-2 could not be evaluated), the patient will not be randomized
  • Must have completed any prior neoadjuvant and adjuvant therapy for resectable disease at least 180 days prior to registration
  • Zubrod performance status of 0-1
More Info Link
Additional information about the study summary and eligibility criteria may be viewed on the U.S. National Institutes of Health (NIH) website.
Phone
(206) 215-3086
Email
CancerResearch@swedish.org