A Phase II Study to Determine the Efficacy and Safety of Panitumumab in Combination With Chemoradiotherapy for Unresectable or Locally Recurrent Adenocarcinoma of the Rectum With or Without Metastatic Disease
Colorectal cancers express EGF and/or EGFR mRNA in 66% of primary tumors, 44% of adjacent
mucosa, and up to 62% of positive lymph nodes. Patients enrolled in NSABP FR-1 will begin
therapy with the anti-EGFR antibody panitumumab--which has shown single-agent activity in
colorectal cancer patients--in combination with CAPOX, an effective treatment for patients
with advanced colorectal cancer, with the convenience of using an oral fluoropyrimidine
(capecitabine.) The intent with this first phase is to expose distant metastases to the
agents early and to shrink the tumor before giving radiation therapy. After chemotherapy,
radiotherapy with capecitabine and panitumumab will be given to destroy the primary tumor.
Panitumumab is added to the radiochemotherapy regimen because data showed positive results
when another anti-EGFR antibody was added to radiotherapy in patients with head and neck
cancer. This approach aims to improve neoadjuvant combined modality therapy for rectal
cancer; it should provide effective therapy for eligible patients and valuable information
about clinical tumor response rates and treatment tolerability, which, if favorable, may be
used to develop future Phase III trials.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Percentage of patients with clinical complete response rate in tumor in the pelvis at 4 to 6 weeks after completion of radiation therapy
Norman Wolmark, MD
National Surgical Adjuvant Breast and Bowel Project Foundation, Inc.
United States: Food and Drug Administration