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

NCT00346099 | Withdrawn Phase 2

• 1 other identifier: NSABP FR-1
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Rectal Cancer; Neoplasm Metastasis

Keywords

NSABP; panitumumab; rectal cancer; colorectal cancer; oxaliplatin; capecitabine; combined modality therapy; combined pelvic radiation therapy; Rectal cancer with or without metastasis

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with clinical complete response rate in tumor in the pelvis at 4 to 6 weeks after completion of radiation therapy

Secondary Outcomes (4)

• 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

Interventions

Panitumumab with capecitabine and oxaliplatin (CAPOX) followed by DRUG

Panitumumab with capecitabine and radiation DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NSABP Foundation Inc: lead
• Amgen: collaborator

MeSH Terms

Conditions

Rectal Neoplasms; Neoplasm Metastasis; Colorectal Neoplasms

Interventions

Panitumumab; Capecitabine; Oxaliplatin; Radiation

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Colonic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals; Physical Phenomena

Study Officials

• Norman Wolmark, MD

  National Surgical Adjuvant Breast and Bowel Project Foundation, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: June 27, 2006
• First Posted: June 29, 2006
• Study Start: June 1, 2006
• Study Completion: May 1, 2007
• Last Updated: January 7, 2008

Record last verified: 2007-12