Pre-operative Chemotherapy Plus Bevacizumab With Early Salvage Therapy Based on PET Assessment of Response in Patients With Locally Advanced But Resectable Gastric and GEJ Adenocarcinoma

PHASE2CompletedINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

August 31, 2008

Primary Completion Date

February 28, 2015

Study Completion Date

February 28, 2015

Conditions
Esophageal CancerGastric Cancer
Interventions
DRUG

epirubicin, cisplatin, capecitabine, bevacizumab, docetaxel and irinotecan

"Patients with FDG avid locally advanced but resectable gastric or GEJ adenocarcinoma will receive preoperative therapy with epirubicin, cisplatin, capecitabine (ECX), and bevacizumab. Each cycle of therapy is 21 days. Near the completion of cycle 1 of therapy (eg during week 3, target days 18-21), patients will undergo a second FDG-PET/CT scan. Note, patients will hold capecitabine for 48 hours prior to the FDG-PET/CT scan.~Patients with a good metabolic response (eg. \> 35% reduction in FDG uptake at the primary tumor on the week 3 PET scan as compared with baseline FDG uptake) will continue ECX for 2 additional cycles (cycle 2 and 3).~Cycle 2 will be administered with bevacizumab and cycle 3 will be administered without bevacizumab. Patients will then proceed to surgery approximately 4-6 weeks following the completion of cycle 3. There is a 10-12 week time interval (eg. 70-84 days) between the last bevacizumab treatment and surgery."

Trial Locations (5)

10065

Memorial Sloan Kettering Cancer Center, New York

Unknown

Memorial Sloan Kettering Cancer Center, Basking Ridge

Memorial Sloan Kettering Cancer Center, Commack

Memorial Sloan Kettering Cancer Center, Rockville Centre

Memoral Sloan Kettering Cancer Center@Phelps, Sleepy Hollow

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Genentech, Inc.

INDUSTRY

collaborator

Weill Medical College of Cornell University

OTHER

lead

Memorial Sloan Kettering Cancer Center

OTHER