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Status: RecruitingPhase: Phase 2Diagnosis: Gastrointestinal Malignancies, Esophageal Cancer, Stomach CancerNCT ID: NCT01747551
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-401
This research study is a Phase II clinical trial to test the safety and effectiveness of the investigational drug Ziv-aflibercept in combination with mFOLFOX6 compared to mFOLFOX6 alone. The drugs used in mFOLFOX6 include Fluorouracil (5-FU), Leucovorin and Oxaliplatin. In patients with esophagogastric cancer, mFOLFOX6 has been used in both clinical trials and standard of care. "Investigational" means that the FDA has not yet approved this combination for the treatment of esophagogastric cancer. Every person has molecules in their bloodstream called vascular endothelial growth factors (VEGFs). These molecules help grow and sustain new blood vessels needed by the human body. Cancer tumors hijack this mechanism because they need new blood vessels and oxygen to grow. Ziv-aflibercept is an antibody, a "targeted therapy" called a "VEGF Trap", that "traps" (binds) these VEGFs and prevents the cancer from using them to grow. Ziv-aflibercept has recently been approved by the FDA for patients with treatment-resistant colorectal cancer. Patients who received standard 5-fluoruracil based chemotherapy pus ziv-aflibercept lived significantly longer than those patients who received standard 5-fluoruracil alone. In this research study, investigators will see if adding ziv-aflibercept to standard chemotherapy (mFOLFOX6) works better than mFOLFOX6 chemotherapy alone in patients with metastatic or unresectable esophagogastric cancer.
Conducting Institutions: Dana-Farber Cancer Institute, Brigham and Women's Hospital, Massachusetts General Hospital, DF/BWCC at South Shore Hospital
Overall PI: Peter Enzinger, MD,
Dana-Farber Cancer Institute
Site-responsible Investigators: Eunice Kwak, MD,
Massachusetts General HospitalReve Shields, MD,
DF/BWCC at South Shore Hospital
Contacts: Dana-Farber Cancer Institute:
Gastrointestinal Research Line, 617-632-5960Massachusetts General Hospital:
Cancer Trials Call Center, 877-789-6100