Study of Panitumumab Given First With Capecitabine and Oxaliplatin (CAPOX) and Then With Capecitabine and Radiation of the Pelvis for Treatment of Patients With Rectal Cancers That May or May Not Have Spread Beyond the Rectum

December 21, 2007 updated by: NSABP Foundation Inc

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

Panitumumab is a monoclonal antibody. It works by attaching to a protein called epidermal growth factor receptor found on normal and cancer cells. When panitumumab attaches, it blocks another protein called epidermal growth factor (EGF) from attaching to the cell. This is important because, when EGF is blocked, a cell's growth slows down or stops. Panitumumab may also help radiation therapy work. Also because panitumumab is a fully-human antibody, it may be less toxic than other monoclonal antibodies made to block the EGF receptor. Chemotherapy, such as capecitabine and oxaliplatin, works to kill cancer cells directly. Capecitabine given during radiation helps radiation therapy work better. This study is being done to learn how rectal cancer tumors that are not removed surgically respond to treatment with panitumumab and chemotherapy given before radiation therapy begins followed by treatment with panitumumab and capecitabine given with radiation therapy.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Percentage of patients with pathologic complete response rate of the primary rectal tumor and resected regional lymph nodes(tissue removed at the time of surgery)
Percentage of patients whose surgical evaluation following therapy indicates candidacy for resection
Percentage of patients who have progressive disease in the pelvis from the time of study entry to 2 years
The toxicity of panitumumab in combination with chemotherapy and in combination with chemoradiotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NSABP Foundation Inc

Collaborators

Amgen

Investigators

  • Principal Investigator: Norman Wolmark, MD, National Surgical Adjuvant Breast and Bowel Project Foundation, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Study Completion (Anticipated)

May 1, 2007

Study Registration Dates

First Submitted

June 27, 2006

First Submitted That Met QC Criteria

June 28, 2006

First Posted (Estimate)

June 29, 2006

Study Record Updates

Last Update Posted (Estimate)

January 7, 2008

Last Update Submitted That Met QC Criteria

December 21, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NSABP FR-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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