Status:
COMPLETED
Evaluating Panitumumab (ABX-EGF) Plus Best Supportive Care Versus Best Supportive Care in Patients With Metastatic Colorectal Cancer
Lead Sponsor:
Amgen
Conditions:
Colorectal Cancer
Metastases
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine that panitumumab, using the proposed regimen, will safely increase progression free survival in patients with metastatic colorectal cancer who have failed ava...
Eligibility Criteria
Inclusion
- Pathologic diagnosis of colorectal adenocarcinoma (diagnostic tissue obtained by tissue biopsy)
- Metastatic colorectal carcinoma
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
- Documented evidence of disease progression during, or following treatment, with fluoropyrimidine, irinotecan and oxaliplatin chemotherapy for metastatic colorectal cancer
- Radiographic documentation of disease progression during or within 6 months following the most recent chemotherapy regimen
- Unidimensionally measurable disease
- Tumor expressing epidermal growth factor receptor (EGFr) by immunohistochemistry
- At least 2 but not more than 3 prior chemotherapy regimens for colorectal cancer
- Adequate hematologic, renal and hepatic function
Exclusion
- Symptomatic brain metastases requiring treatment
- History or evidence of interstitial pneumonitis or pulmonary fibrosis
- Use of systemic chemotherapy or radiotherapy within 30 days prior to enrollment
- Prior epidermal growth factor receptor (EGFr) targeting therapies
- Prior anti-tumor therapies including prior experimental agents or approved anti-tumor small molecules and biologics of short (less than a week) serum half life within 30 days before enrollment, or prior experimental or approved proteins within 3 months before enrollment.
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
463 Patients enrolled
Trial Details
Trial ID
NCT00113763
Start Date
January 1 2004
End Date
June 1 2009
Last Update
November 7 2022
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