Phase II Study of Irinotecan and Cetuximab With or Without Vemurafenib in BRAF Mutant Metastatic Colorectal Cancer

April 09, 2015
Colorectal Cancer
Alexander Hantel, MD

Naperville, Plainfield

This randomized phase II trial studies how well irinotecan hydrochloride and cetuximab with or without vemurafenib works in treating patients with colorectal cancer that has spread to nearby tissue or lymph nodes, that has spread to other places in the body, or cannot be removed by surgery. Irinotecan hydrochloride and vemurafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab, may block the ability of tumor cells to grow and spread. It is not yet known whether irinotecan hydrochloride and cetuximab are more effective with or without vemurafenib in treating colorectal cancer.

Sponsor: SWOG (formerly the Southwest Oncology Group)

  • Histologically or cytologically confirmed adenocarcinoma of the colon or rectum that is either metastatic, or locally advanced and unresectable 
  • Must have BRAFV600E mutant status
  • Must have received prior first-line therapy comprising oxaliplatin-based fluoropyrimidine-containing chemotherapy and bevacizumab for metastatic colorectal cancer
  • Must have had one or two prior regimens of systemic chemotherapy for metastatic disease; prior treatment with irinotecan is allowed; a maintenance regimen of 5-fluorouracil or capecitabine should not be counted as a separate line of treatment; prior treatment for metastatic disease is not required for patients who experienced disease recurrence during or within 6 months of completion of adjuvant chemotherapy
  • Brain metastases are allowed if they have been adequately treated and stable for at least 90 days prior to registration
  • Must not have a tumor with a mutation detected in codons 12 or 13 in KRAS; nor with a known mutation detected in codons 61, 117, or 146 of KRAS or NRAS

3-5-6 years

Accepting Participants
Kathy Seymour, BSN