Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

The purpose of this study is to determine the treatment effect of panitumumab in combination with FOLFOX compared to FOLFOX alone as first line therapy for metastatic colorectal cancer

Eligibility Criteria

Inclusion Criteria:

• Man or woman at least 18 years old

• Diagnosis of metastatic colorectal cancer

• At least 1 uni-dimensionally measurable lesion of at least 20mm per modified RECIST

• ECOG performance status of 0, 1, or 2

• Paraffin-embedded tumor tissue from the primary tumor or metastasis available for central analyse Exclusion Criteria:

• History or known presence of CNS metastases

• History of another primary cancer, except: Curatively treated in situ cervical cancer, or Curatively resected non-melanoma skin cancer, or Other primary solid tumor curatively treated with no known active disease present and no treatment administered for ≥ 5 years before randomization

• Prior chemotherapy or systemic therapy for the treatment of metastatic colorectal carcinoma except: adjuvant fluoropyrimidine-based chemotherapy or prior fluoropyrimidine therapy administered solely for the purpose of radiosensitization

• Prior oxaliplatin therapy

• Prior anti-EGFr antibody therapy (eg, cetuximab) or treatment with small molecule EGFr inhibitors (eg, erlotinib)

• Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) 1 year prior to randomization History of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest CT scan

• Active inflammatory bowel disease or other bowel disease causing chronic diarrhea (defined as > CTC grade 2 [CTCAE version 3.0])

• Peripheral sensory neuropathy with functional impairment

Trial Contact Information

Trial Lead Organizations/Sponsors

Amgen, Incorporated

MD

Study Director

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00364013
Information obtained from ClinicalTrials.gov on November 20, 2012

Back to Top