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 - Full Text View

Sponsors and Collaborators:	National Surgical Adjuvant Breast and Bowel Project (NSABP) Amgen
Information provided by:	National Surgical Adjuvant Breast and Bowel Project (NSABP)
ClinicalTrials.gov Identifier:	NCT00346099

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 II

MedlinePlus related topics: Cancer

Drug Information available for: Capecitabine Oxaliplatin Panitumumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
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

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

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

Responsible Party:	NSABP Foundation, Inc. ( Norman Wolmark, MD )
Study ID Numbers:	NSABP FR-1
Study First Received:	June 27, 2006
Last Updated:	December 21, 2007
ClinicalTrials.gov Identifier:	NCT00346099
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

Study placed in the following topic categories:

Capecitabine
Digestive System Neoplasms
Rectal Neoplasms
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Recurrence
Intestinal Neoplasms

Rectal neoplasm
Oxaliplatin
Digestive System Diseases
Neoplasm Metastasis
Gastrointestinal Neoplasms
Adenocarcinoma
Rectal cancer
Colorectal Neoplasms

Additional relevant MeSH terms:

Antimetabolites
Neoplastic Processes
Neoplasms
Antimetabolites, Antineoplastic
Pathologic Processes

Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009