Status:
COMPLETED
A Phase II Trial of Modified FOLFOX 6 and Cetuximab in First Line Treatment of Metastatic Colorectal Cancer
Lead Sponsor:
Veeda Oncology
Collaborating Sponsors:
Bristol-Myers Squibb
Sanofi
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 re...
Detailed Description
The current treatment options for metastatic colon cancer are in need of further improvement. The three-drug combination of oxaliplatin with 5-FU/LV for the first-line treatment of metastatic colorect...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2005
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT00251485
Start Date
March 1 2004
End Date
June 1 2005
Last Update
August 21 2008
Active Locations (1)
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1
Veeda Oncology
Houston, Texas, United States, 77042