Status:
COMPLETED
Panitumumab (ABX-EGF) Monotherapy in Patients With Metastatic Colorectal Cancer
Lead Sponsor:
Amgen
Conditions:
Colorectal Cancer
Metastases
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine that panitumumab will have clinically meaningful anti-tumor activity in patients with metastatic colorectal cancer who have developed progressive disease or r...
Eligibility Criteria
Inclusion
- Pathologic diagnosis of colorectal adenocarcinoma (diagnostic tissue obtained by tissue biopsy)
- Metastatic colorectal carcinoma
- Eastern Cooperative Oncology Group 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 is required
- Bidimensionally measurable disease
- Tumor expressing low to negative levels of epidermal growth factor receptor (EGFr) by immunohistochemistry
- At least 2 but no more than 3 prior chemotherapy regimens for metastatic colorectal cancer
- Adequate hematologic, renal and hepatic function
Exclusion
- Symptomatic brain metastases requiring treatment
- Patient with a history of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis
- Use of systemic chemotherapy or radiotherapy within 30 days before enrollment
- Prior anti-EGFr antibody therapy with the exception of the small molecule EGFr tyrosine kinase inhibitors, which are permitted
- Prior anti-tumor therapies including prior experimental agents or approved anti-tumor small molecules and biologics of short (less than 1 week) serum half-life within 30 days before enrollment, or prior experimental or approved proteins within 6 weeks before enrollment
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
203 Patients enrolled
Trial Details
Trial ID
NCT00089635
Start Date
August 1 2004
End Date
August 1 2008
Last Update
November 7 2022
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