Clinical Trials

A Phase II Study of mFOLFOX6 with Bevacizumab or Tivozanib in Patients with Metastatic Colorectal Cancer

Protocol
12-066
Full Title
A Phase 2, Open Label, Multicenter, Randomized Trial Comparing Tivozanib in Combination with mFOLFOX6 with Bevacizumab in Combination with mFOLFOX6 in Stage IV Metastatic Colorectal Cancer (mCRC) Subjects
Purpose

A combination of three chemotherapy drugs called mFOLFOX6 is a standard treatment for metastatic colorectal cancer. Bevacizumab is also used to treat this disease; it works by inhibiting the development of the blood vessels that tumors need to grow and spread, by blocking the activity of a protein called VEGF.

Tivozanib is an investigational drug that also blocks tumor blood vessel development by targeting VEGF. In this study, researchers are comparing the safety and effectiveness of tivozanib plus mFOLFOX6 versus bevacizumab plus mFOLFOX6 in patients with metastatic colorectal cancer. Patients will be randomly assigned to receive one dug combination or the other, but not both.

Tivozanib is a pill that is taken orally (by mouth). The other medications are given intravenously (by vein).

Investigator
Andrea Cercek, MD
Andrea Cercek - Physician Profile
Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have metastatic colorectal cancer.
  • Patients may not have previously received chemotherapy for metastatic colorectal cancer.
  • At least 6 months must have passed since completion of prior fluorouracil therapy.
  • If a patient received prior adjuvant chemotherapy for stage II or III disease, then he or she must have remained cancer-free for at least 6 months after completion of that therapy.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • Patients must be age 18 or older.
  • Patients must be willing and able to receive all chemotherapy treatments at Memorial Sloan-Kettering Cancer Center.

For more information about this study and to inquire about eligibility, please contact Dr. Andrea Cercek at 646-888-4189.

Disease(s)
Colorectal Cancer
Colorectal Cancer: Colon Cancer
Locations
ClinicalTrials.gov
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