Research Study Summary
SWOG S1201 Phase II Randomized, Pilot Study of FOLFOX Therapy Comprising Oxaliplatin, Leucovorin Calcium, and Fluorouracil Versus Irinotecan Hydrochloride and Docetaxel in Patients With Advanced or Metastatic Esophageal Cancer, Gastric Cancer, or Gastroesophageal Junction Cancer
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).
Patient Inclusion Criteria:
- Age >18 years
- Patients 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 must not have brain metastases
- 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
- Zubrod performance status of 0-1
Patient Exclusion Criteria:
Patients must not have motor or sensory neuropathy > Grade 1 using CTCAE version 4.0
Patients must not be pregnant or nursing; women and men of reproductive potential must have agreed to use an effective contraceptive method
No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for five years
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