Cetuximab, 5-FU and Radiation as Neoadjuvant Therapy for Patients With Locally Advanced Rectal Cancer
This study is currently recruiting participants.
Verified April 2013 by Dana-Farber Cancer Institute
Sponsor:
Dana-Farber Cancer Institute
Collaborators:
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Bristol-Myers Squibb
Information provided by (Responsible Party):
Jeffrey A. Meyerhardt, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00611858
First received: January 29, 2008
Last updated: April 30, 2013
Last verified: April 2013
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Purpose
The standard treatment for rectal cancer is to receive the chemotherapeutic drug 5-fluorouracil (5-FU) with radiation therapy before having surgery to remove the rectal cancer. This is known as neoadjuvant chemoradiotherapy. The purpose of this research study is to determine if Cetuximab improves the benefits of neoadjuvant chemoradiotherapy when given with 5-FU and radiation therapy. The epidermal growth factor (EGF) receptor, which is found in rectal cancer, is a specific part of the cancer that is felt to encourage tumor growth. Cetuximab targets and blocks the EGF receptor and has been shown to be safe and effective in treating colorectal cancer and head and neck cancers.
| Condition | Intervention | Phase |
|---|---|---|
|
Rectal Cancer |
Drug: Cetuximab Drug: 5-Fluorouracil Radiation: External Beam Pelvis Radiation Therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of Cetuximab, 5-FU and Radiation as Neoadjuvant Therapy for Patients With Locally Advanced Rectal Cancer |
Resource links provided by NLM:
Further study details as provided by Dana-Farber Cancer Institute:
Primary Outcome Measures:
- Determine the pathological complete response rate of cetuximab with standard 5-FU and radiation as neoadjuvant therapy in patients with stage II/III rectal cancer. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Determine complete resection rate, local recurrence rate, distance recurrence rate, disease free survival and overall survival in this patient population with this treatment. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Characterize toxicity profile of neoadjuvant therapy with cetuximab, 5-FU and radiation in this patient population. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 25 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: Cetuximab
Given once a week for 9 weeks
Drug: 5-Fluorouracil
Given by continuous infusion for weeks 4 through 9
Other Name: 5-FU
Radiation: External Beam Pelvis Radiation Therapy
Monday through Friday beginning after the 2nd sigmoidoscopy and biopsy is completed
- Prior to the first dose of cetuximab, participants will undergo a sigmoidoscopy with biopsy for research purposes as well collection of blood samples. These tests will be repeated between days 16 and 21.
- After treatment begins, participants will undergo the following every week; history and physical exam; vital signs; blood tests.
- On treatment weeks 1, 2 and 3: cetuximab is given once a week. On weeks 4 through 9: cetuximab is given weekly; continuous infusion of 5-FU will begin on day 22; treatment with radiation therapy Monday through Friday.
- It is recommended that the participant undergo surgery 4 to 8 weeks after completion of therapy to attempt to remove the tumor.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically confirmed adenocarcinoma of the rectum that begins within 15cm of the anal verge as determined by sigmoidoscopy and/or colonoscopy, with no evidence of distant metastatic disease. A complete colonoscopy to the cecum is recommended prior to initiating protocol therapy.
- Staging with transrectal ultrasound or endorectal coil MRI to confirm clinical stage of T3 or T4 or lymph node positive rectal adenocarcinoma
- Tumor is K-ras wildtype by method of choice at respective institution (testing codons 12 and 13)
- Performance status: ECOG less than or equal to 2
- 18 years of age or older
- No evidence of metastatic disease by abdominal/pelvic CT and chest imaging
- Adequate bone marrow, renal,and hepatic function as outlined in protocol
- All patients will be evaluated by a surgeon and considered a candidate for definitive surgery
- Coumadin or heparin management for line care of other indications is permitted. The INR will be monitored weekly in patients taking coumadin.
Exclusion Criteria:
- Prior treatment for this malignancy
- Prior history of pelvic radiation therapy
- Prior history of 5-FU based or EGFR receptor inhibitor therapy
- Prior history of an allergic reaction to a monoclonal antibody
- Uncontrolled serious medical or psychiatric illness
- Significant history of uncontrolled cardiac disease
- Sexually active women of childbearing potential must use an effective method of birth control during the course of the study
- Unwilling to agree to pre and post-cetuximab sigmoidoscopy and biopsy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00611858
Locations
| United States, Massachusetts | |
| Dana-Farber Cancer Institute | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Michele Vincitore 617-632-5960 | |
| Principal Investigator: Jeffrey Meyerhardt, MD, MPH | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: David Ryan, MD 617-643-3813 | |
| Principal Investigator: David Ryan, MD | |
| South Shore Hospital | Recruiting |
| Weymouth, Massachusetts, United States | |
| Contact: Rolf Freiter 781-624-4690 patricia_nestor@dfci.harvard.edu | |
| United States, Tennessee | |
| Vanderbilt Medical Center | Recruiting |
| Nashville, Tennessee, United States | |
| Contact: Bapsi Chakravarthy 615-322-6445 bapsi.chak@Vanderbilt.Edu | |
Sponsors and Collaborators
Dana-Farber Cancer Institute
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Bristol-Myers Squibb
Investigators
| Principal Investigator: | Jeffrey Meyerhardt, MD, MPH | Dana-Farber Cancer Institute |
More Information
No publications provided
| Responsible Party: | Jeffrey A. Meyerhardt, MD, Principal Investigator, Dana-Farber Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00611858 History of Changes |
| Other Study ID Numbers: | 07-297, BMS CA225302 |
| Study First Received: | January 29, 2008 |
| Last Updated: | April 30, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Dana-Farber Cancer Institute:
|
5-FU cetuximab radiation adenocarcinoma of the rectum neoadjuvant therapy |
Additional relevant MeSH terms:
|
Rectal Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases |
Fluorouracil Cetuximab Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013