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Status: RecruitingPhase: Phase 2Diagnosis: Gastrointestinal Malignancies, Liver CancerNCT ID: NCT01775501
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-218
This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational combination of drugs to learn whether the drug combination works in treating a specific cancer. "Investigational" means that the modified FOLFOX and sorafenib combination is still being studied and that research doctors are trying find out more about it-such as the safest dose to use, the side effects it may cause, and if the combination is effective for treating different types of cancer. It also means that the FDA has not yet approved the modified FOLFOX and sorafenib combination that will be used in this study for liver cancer. FOLFOX is a combination of three drugs: folinic acid (leucovorin), fluorouracil (5-FU), and oxaliplatin. The dosage amounts for some of these FDA approved drugs will be modified slightly in this study. The FOLFOX combination is approved by the FDA and is a standard treatment of colorectal cancer. However, it is not approved for the treatment of liver cancer. Sorafenib is a new drug, which is approved under the brand name Nexavar for the treatment of liver cancer. It is also currently being tested in various other cancers. Sorafenib works by slowing down and/or stopping the development of new cancer cells and new blood vessels. By slowing down and/or stopping the growth of new blood vessels around a tumor, it is believed that sorafenib prevents or slows down the growth of tumors. In this research study, sorafenib, the standard treatment, is being combined with modified FOLFOX, which has shown some antitumor activity in liver cancer.
Conducting Institutions: Massachusetts General Hospital, Dana-Farber Cancer Institute, Brigham and Women's Hospital, Beth-Israel Deaconess Medical Center
Overall PI: Andrew Zhu, MD, PhD,
Massachusetts General Hospital
Site-responsible Investigators: Thomas Abrams, MD,
Dana-Farber Cancer InstituteRebecca Miksad, MD,
Beth Israel Deaconess Medical Center
Contacts: Massachusetts General Hospital:
Cancer Trials Call Center, 877-789-6100Dana-Farber Cancer Institute:
Gastrointestinal Research Line, 617-632-5960Beth-Israel Deaconess Medical Center:
Cancer Trials Call Center, 617-667-3060