A Phase II Trial of Modified FOLFOX 6 and Cetuximab in First Line Treatment of Metastatic Colorectal Cancer

NCT00251485 | Completed Phase 2

• 1 other identifier: I-03-002
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase II, open label, non-randomized study in patients with histologically or pathologically confirmed diagnosis of stage IIIB/IV, EGFR+ adenocarcinoma of the colon or rectum who have not received prior chemotherapy for their metastatic disease. Primary Study Endpoint: To assess the response rate, progression-free survival, and overall safety profile of a modified FOLFOX 6 plus cetuximab regimen in the first-line treatment of patients with metastatic colorectal cancer. Secondary Study Endpoint(s): To assess overall survival of patients with metastatic colorectal cancer who receive first-line therapy with a modified FOLFOX 6 + cetuximab regimen.

Conditions

Colorectal Cancer

Keywords

Metastatic 1st line colorectal cancer

Outcome Measures

Primary Outcomes (1)

• To assess the response rate, progression-free survival, and overall safety profile of a modified FOLFOX 6 plus cetuximab regimen in the first-line treatment of patients with metastatic colorectal cancer.

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Secondary Outcomes (1)

• To assess overall survival of patients with metastatic colorectal cancer who receive first-line therapy with a modified FOLFOX 6 + cetuximab regimen

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Interventions

Cetuximab DRUG

Cycle 1: 400 mg/m2 (given as a 2-hour infusion) on Day 1, then 250 mg/m2, Day 8 (given as a 1-hour infusion) subsequent cycles:250 mg/m2, Day 1 and Day 8 (given as a 1-hour infusion)

Eligibility Criteria

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

You may qualify if:

• Patients must have signed an IRB approved informed consent.
• Patients with histologically or pathologically documented, stage IIIB or IV adenocarcinoma of the colon or rectum.
• Patients with disease that is not amenable to potentially curative resection (i.e., inoperable metastatic disease).
• Patients with tumors that are EGFR + by IHC staining.
• Patients with ECOG Performance status of 0 or 1.
• Patients, 18 years and older, must either be not of child bearing potential or have a negative serum pregnancy test within 7 days prior to registration. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or they are postmenopausal.
• Bone marrow function: absolute neutrophil count (ANC) \> or = 1,500/uL, equivalent to Common Terminology Criteria for Adverse Events (CTCAE, version 3) Grade 1. Platelets \> or = 100,000/uL (CTCAE Grade 0 - 1).
• Renal function: creatinine \< or = 1.5 x institutional upper limit of normal (ULN), CTCAE Grade 1.
• Hepatic function: bilirubin \< or = 1.5 x ULN, CTCAE Grade 1. AST \< or = 2.5 x ULN, CTCAE Grade 1.

You may not qualify if:

• Patients who received prior chemotherapy for metastatic disease. Prior adjuvant therapy with 5FU/LV and/or irinotecan is allowed provided it was completed at least 6 months prior to enrollment in this study.
• Patents who received prior oxaliplatin.
• Patients who received prior cetuximab or other therapy which specifically and directly targets the EGF pathway.
• Patients with acute hepatitis.
• Patients with active or uncontrolled infection.
• Patients with a significant history of cardiac disease, i.e., uncontrolled hypertension, unstable angina, and congestive heart failure.
• Prior allergic reaction to chimerized or murine monoclonal antibody therapy.
• Any concurrent chemotherapy not indicated in the study protocol or any other investigational agent.
• Patients with peripheral neuropathy \> grade 1

Sponsors & Collaborators

• Veeda Oncology: lead
• Bristol-Myers Squibb: collaborator
• Sanofi: collaborator

Study Sites (1)

Veeda Oncology

Houston, Texas, 77042, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Cetuximab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Ralph Boccia, MD

  Veeda Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 8, 2005
• First Posted: November 10, 2005
• Study Start: March 1, 2004
• Primary Completion: June 1, 2005
• Study Completion: June 1, 2005
• Last Updated: August 21, 2008

Record last verified: 2008-08

Locations

US (1)