At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating FOLFOX regimen, docetaxel, and 4 other interventions for Adenocarcinoma of the Gastroesophageal Junction and 2 related conditions. Completed, enrolled 213 participants across 508 sites.
Detailed Summary
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.
Study Details
Timeline
Interventions
Given IV. Fluorouracil, oxaliplatin, \& leucovorin calcium.
30 mg/m\^2, IV over 30 minutes on Day 1,8 of each 21 day cycle.
400 mg/m\^2, IV bolus on Day 1 of each 14 day cycle; 2400 mg/m\^2 IV over 46-48 hours on Days 1-2 of each 14 day cycle.
65 mg/m\^2, IV over 90 minutes on Days 1 \& 8 of every 21 day cycle.
400 mg/m\^2, IV over 2 hours on Day 1 of every 14 day cycle.
85 mg/m\^2, IV over 2 hours on Day 1 of every 14 day cycle.