A Phase 2 Study of Paclitaxel with Cisplatin vs Fluoropyrimidine with a Platinum Agent for NeoadjuvantTherapy in Operable Esophageal Cancer Based on CHFR Methylation Status in Diagnostic Biopsies
To see if testing tumors for methylation of a gene called CHFR and personalizing the choice of chemotherapy treatment using this test can improve the number of patients who have responded to their chemotherapy and radiation treatment at the time of surgery. This study uses a test done on each patient's tumor to make a personalized chemotherapy treatment choice out of several options that are standard chemotherapy combinations.
-stage II or III confirmed adenocarcinoma of the esophagus or GE junction -no prior chemotherapy, radiation, or surgery for this cancer -good physical condition with good blood counts and organ function -disease-free of any prior malignancy for at least 3 years -tumor that is accessible to biopsy and surgically resectable -certain medications are prohibited while on treatment -no uncontrolled medical or psychological conditions -must not be HIV-positive -must have PET scan and endoscopic ultrasound for staging disease
Patients consenting to the study will have their tumor tissue analyzed for CHFR hypermethylation. Patient's found to have a methylated cancer type will receive Paclitaxel and Cisplatin chemotherapy weekly during 5 weeks of radiation followed by esophagectomy surgery. Patient's found to have an un-methylated cancer type will receive 5-fluorouracil given with either oxaliplatin or cisplatin chemotherapy at varying intervals during 5 weeks of radiation followed by esophagectomy surgery.
05/20/2013 04:02 AM