Gastric Cancer Clinical Trial
Official title:
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:
- To assess progression-free survival of high-excision repair cross-complementing 1(ERCC1)
patients with advanced or metastatic cancer of the esophagus, stomach, or
gastroesophageal junction (GEJ) treated with FOLFOX comprising oxaliplatin, leucovorin
calcium, and fluorouracil compared to those treated with irinotecan hydrochloride plus
docetaxel.
- To assess progression-free survival of low-ERCC1 patients with advanced or metastatic
cancer of the esophagus, stomach, or GEJ treated with FOLFOX compared to those treated
with irinotecan hydrochloride plus docetaxel.
- To assess progression-free survival of low-ERCC1 patients with advanced or metastatic
cancer of the esophagus, stomach, or GEJ treated with FOLFOX compared to high-ERCC1
patients treated with FOLFOX.
- To assess overall survival of and toxicities in each of the two treatment arms in this
group of patients.
- To assess the response probability (confirmed and unconfirmed, complete and partial
responses) in the subset of patients with measurable disease in each of the two
treatment arms.
- To explore whether there is evidence of interaction between treatment arm and ERCC1
expression in this group of patients. (Exploratory)
- To bank tissue and blood for future translational medicine studies; a) To explore the
relationship of ERCC-1 and ERCC-2 single nucleotide polymorphism (SNP) genotypes with
clinical outcome in these patients; and b) To explore the association between germline
variations in these SNPs and ERCC-1 mRNA expression in these patients. (Exploratory)
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.
- Arm I (FOLFOX): Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV
over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-2. Courses repeat
every 14 days in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive irinotecan hydrochloride IV over 90 minutes and docetaxel IV
over 30-60 minutes on days 1 and 8. Courses repeat every 21 days in the absence of
disease progression or unacceptable toxicity.
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.
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