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
18 Years
N/A
Both
Rectal Cancer, Neoplasm Metastasis
Trial Information
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.
Inclusion Criteria:
- Pathologic diagnosis of rectal cancer (adenocarcinoma)
- Must have rectal cancer that is:
- locally advanced and considered not to be curable by surgery
- recurrent (if it was treated before by surgical removal of the tumor)
- present along with small-volume metastasis
- Evidence of adequate organ function (such as liver, kidneys, etc.)
- Must be able to swallow tablets
- Able to perform an adequate level of physical activity
Exclusion Criteria:
- Diagnosis of rectal cancer other than adenocarcinoma
- Patients who are candidates for surgical removal of metastatic and/or locally
advanced disease
- Patients who have received previous treatments for the current cancer
- Chronic liver disease or recurrent viral hepatitis
- Any previous pelvic radiation therapy and/or any previous chemotherapy with
oxaliplatin or epidermal growth factor receptor inhibitors
- Central nervous system metastases
- Active inflammatory bowel disease
- Current clinically significant abnormal peripheral nerve disease
- Active heart disease, including blocked blood vessels, recent heart attack, history
of congestive heart failure, or abnormal heart beat
- Pregnancy or breast feeding
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Percentage of patients with clinical complete response rate in tumor in the pelvis at 4 to 6 weeks after completion of radiation therapy
Safety Issue:
No
Principal Investigator
Norman Wolmark, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
National Surgical Adjuvant Breast and Bowel Project Foundation, Inc.
Authority:
United States: Food and Drug Administration
Study ID:
NSABP FR-1
NCT ID:
NCT00346099
Start Date:
June 2006
Completion Date:
May 2007
Related Keywords:
- Rectal Cancer
- Neoplasm Metastasis
- NSABP
- panitumumab
- rectal cancer
- colorectal cancer
- oxaliplatin
- capecitabine
- combined modality therapy
- combined pelvic radiation therapy
- Rectal cancer with or without metastasis
- Neoplasms
- Rectal Neoplasms
- Neoplasm Metastasis
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