FOLFOX Plus Regorafenib in Patients With Unresectable or Metastatic Esophagogastric Cancer
The purpose of this study is to evaluate the effects, good and/or bad, of the drug regorafenib with chemotherapy regime (FOLFOX). This is a a Phase II trial that will study if this new treatment is effective and safe in patients with esophagus and stomach cancer.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of FOLFOX Plus Regorafenib in Patients With Unresectable or Metastatic Esophagogastric Cancer|
- progression free survival (PFS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- overall survival (OS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]Overall survival will be measured from the start of treatment to death or last follow-up and will be estimated using the Kaplan-Meier method
- response rate [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]This is defined as the percentage of patients who have achieved either an objective complete or partial target lesion response that is confirmed on the RECIST 1.1 criteria. Complete or partial responses will be confirmed with repeat CT evaluation after 4 weeks.
- Toxicity [ Time Frame: 2 weeks (14 days) prior to receiving study treatment (+/- 7 days) ] [ Designated as safety issue: Yes ]The type, frequency, severity, timing, and relationship of each adverse event will be determined as per the NCI Common Toxicity Criteria, version 4.0. Toxicity during cycle 1 and subsequent cycles will be reported.
|Study Start Date:||July 2013|
|Estimated Study Completion Date:||July 2016|
|Estimated Primary Completion Date:||July 2016 (Final data collection date for primary outcome measure)|
Experimental: FOLFOX Plus Regorafenib
Regorafenib 160 mg daily on days 4 to 10 and days 18 to 24 as four 40 mg coprecipitate tablets + mFOLFOX on Day 1 and Day 15 of each cycle. Each cycle consists of 28 days. All patients will receive systemic chemotherapy with the mFOLFOX regimen and regorafenib. The specific version of the FOLFOX regimen used at MSKCC is mFOLFOX6. mFOLFOX6 will be given on Day 1 of each cycle. Patients will receive Oxaliplatin 85 mg/m2 IV (over 120 minutes), leucovorin 400 mg/m2 IV (over 120 minutes), 5-FU 400 mg/m2 IVP, and 5-FU 1200 mg/m2/day CIVI x 2 days, every two weeks. Treatment will be performed on the scheduled day ± 7 days. In case of discontinuation of FOLFOX due to cumulative toxicity and administration as a single agent during the study, regorafenib for patient convenience will be administered 160 mg daily for 3 weeks on/1 week off. The 3 weeks on/1 week off schedule is supported by the single agent regorafenib data in colon cancer and GIST.
Other Name: (Bay 73-4506)Drug: 5-Fluorouracil Drug: Leucovorin Drug: Oxaliplatin
Please refer to this study by its ClinicalTrials.gov identifier: NCT01913639
|United States, New Jersey|
|Memoral Sloan Kettering Cancer Center|
|Basking Ridge, New Jersey, United States|
|United States, New York|
|Memorial Sloan Kettering Cancer Center @ Suffolk|
|Commack, New York, United States, 11725|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Memorial Sloan Kettering at Mercy Medical Center|
|Rockville Centre, New York, United States|
|Memoral Sloan Kettering Cancer Center@Phelps Memorial Hospital|
|Sleepy Hollow, New York, United States|
|Principal Investigator:||Yelena Janjigian, MD||Memorial Sloan Kettering Cancer Center|