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
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
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, fluorouracil, irinotecan hydrochloride, and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of combination chemotherapy is more effective in treating tumor cells.
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.
OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are stratified according to ERCC1 expression (high [≥ 1.7] vs low [< 1.7]), and disease site (esophageal vs gastric/gastroesophageal junction). Patients are randomized to 1 of 2 treatment arms.
Blood and tumor tissue samples may be collected for ERCC1 expression analysis and future research studies.
After completion of study treatment, patients are followed up every 3 months for up to 3 years.
DISEASE CHARACTERISTICS:
Patients must have unresectable advanced or metastatic histologically or cytologically confirmed adenocarcinoma of the esophagus, stomach, or gastroesophageal junction (GEJ)
Patients must have measurable and/or non-measurable 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, a second specimen must be submitted 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
Patients must have completed any prior neoadjuvant and adjuvant therapy for resectable disease at least 180 days prior to registration
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Orange, California 92868, United States
Englewood, Colorado 80113, United States
Hollywood, Florida 33021, United States
Highland Park, Illinois 60035, United States
Shreveport, Louisiana 71130, United States
Ann Arbor, Michigan 48106, United States
Jefferson City, Missouri 65109, United States
Springfield, Missouri 65804, United States
Charleston, South Carolina 29414, United States
Spartanburg, South Carolina 29307, United States
Seattle, Washington 98109, United States
Stevens Point, Wisconsin 54481, United States