Status:
COMPLETED
Dual Epidermal Growth Factor Receptor Inhibition With Erlotinib and Panitumumab With or Without Chemotherapy for Advanced Colorectal Cancer
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
Genentech, Inc.
OSI Pharmaceuticals
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as panitumumab, can block tumor growth in diff...
Detailed Description
OBJECTIVES: Primary * Determine the response rate in patients with metastatic colorectal cancer treated with erlotinib hydrochloride and panitumumab with versus without irinotecan hydrochloride as s...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed colorectal cancer
- Metastatic disease
- Biopsy of either the primary cancer or metastatic site required
- Tumor expressing wild-type Kras mutations
- Progressive disease within 3 months after treatment with first-line fluorouracil (5-FU) and oxaliplatin-based chemotherapy OR evidence of metastatic disease within 6 months of completing adjuvant therapy with 5-FU and oxaliplatin
- Measurable disease defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques OR as ≥ 10 mm with spiral CT scan
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy \> 6 months
- ANC \> 1,500/mm\^3
- Platelet count \> 100,000/mm\^3
- Hemoglobin ≥ 9 g/dL
- Creatinine \< 1.5 times upper limit of normal (ULN)
- Bilirubin \< 1.5 times ULN (or \< 2 mg/dL)
- AST and/or ALT \< 3 times ULN (\< 5 times ULN with liver metastases)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No concurrent malignancy requiring therapy except minor surgery for non-melanoma skin cancer removal
- No interstitial lung disease with symptoms (e.g., dyspnea or cough) including any of the following significant conditions:
- Parenchymal lung disease
- Metastatic disease
- Pulmonary infections
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior EGFR inhibitors, irinotecan hydrochloride, or other second-line chemotherapy regimens
- More than 4 weeks since prior radiotherapy
- No other concurrent investigational agents
- No other concurrent anticancer treatment modalities (e.g., radiotherapy)
Exclusion
Key Trial Info
Start Date :
January 18 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00940316
Start Date
January 18 2010
End Date
January 1 2015
Last Update
May 7 2019
Active Locations (10)
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1
Cancer Care & Hematology Specialists of Chicagoland
Arlington Heights, Illinois, United States, 60005
2
Northwestern University, Northwestern Medical Faculty Foundation
Chicago, Illinois, United States, 60611-3013
3
Hematology/Oncology Associates
Chicago, Illinois, United States, 60611
4
Joliet Oncology-Hematology Associates, Ltd.
Joliet, Illinois, United States, 60435