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

This study has been withdrawn prior to enrollment.
(Protocol closed based on new (and as yet unpublished) information from a phase II clinical trial.)
Sponsor:
Collaborator:
Amgen
Information provided by:
National Surgical Adjuvant Breast and Bowel Project (NSABP)
ClinicalTrials.gov Identifier:
NCT00346099
First received: June 27, 2006
Last updated: December 21, 2007
Last verified: December 2007
  Purpose

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.


Condition Intervention Phase
Rectal Cancer
Neoplasm Metastasis
Drug: Panitumumab with capecitabine and oxaliplatin (CAPOX) followed by
Drug: Panitumumab with capecitabine and radiation
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by National Surgical Adjuvant Breast and Bowel Project (NSABP):

Primary Outcome Measures:
  • Percentage of patients with clinical complete response rate in tumor in the pelvis at 4 to 6 weeks after completion of radiation therapy [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) [ Designated as safety issue: No ]
  • Percentage of patients whose surgical evaluation following therapy indicates candidacy for resection [ Designated as safety issue: No ]
  • Percentage of patients who have progressive disease in the pelvis from the time of study entry to 2 years [ Designated as safety issue: No ]
  • The toxicity of panitumumab in combination with chemotherapy and in combination with chemoradiotherapy [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: June 2006
Estimated Study Completion Date: May 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00346099

Sponsors and Collaborators
National Surgical Adjuvant Breast and Bowel Project (NSABP)
Amgen
Investigators
Principal Investigator: Norman Wolmark, MD National Surgical Adjuvant Breast and Bowel Project Foundation, Inc.
  More Information

No publications provided

Responsible Party: Norman Wolmark, MD, NSABP Foundation, Inc.
ClinicalTrials.gov Identifier: NCT00346099     History of Changes
Other Study ID Numbers: NSABP FR-1
Study First Received: June 27, 2006
Last Updated: December 21, 2007
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by National Surgical Adjuvant Breast and Bowel Project (NSABP):
NSABP
panitumumab
rectal cancer
colorectal cancer
oxaliplatin
capecitabine
combined modality therapy
combined pelvic radiation therapy
Rectal cancer with or without metastasis

Additional relevant MeSH terms:
Neoplasms
Rectal Neoplasms
Neoplasm Metastasis
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Oxaliplatin
Capecitabine
Fluorouracil
Antibodies, Monoclonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 26, 2014