Dual Epidermal Growth Factor Receptor Inhibition With Erlotinib and Panitumumab With or Without Chemotherapy for Advanced Colorectal Cancer
Colorectal Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring recurrent colon cancer, stage IV colon cancer, recurrent rectal cancer, stage IV rectal cancer
Eligibility Criteria
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)
Sites / Locations
- Cancer Care & Hematology Specialists of Chicagoland
- Northwestern University, Northwestern Medical Faculty Foundation
- Hematology/Oncology Associates
- Joliet Oncology-Hematology Associates, Ltd.
- Hope Cancer Center
- Cancer Center of Kansas
- Nebraska Methodist Hospital
- Virtua Memorial (Regional Cancer Care Associates of Mount Holly)
- Mercy Clinic Oncology and Hematology
- The Jones Clinic
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Arm A: Erlotinib + Panitumumab + Irinotecan
Arm B: Erlotinib + Panitumumab
Arm C: Erlotinib + Panitumumab
Patients receive oral erlotinib hydrochloride once daily on days 1-14, panitumumab IV over 30-90 minutes on day 1, and irinotecan hydrochloride IV over 90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.
Patients receive oral erlotinib hydrochloride once daily on days 1-14 and panitumumab IV over 30-90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients receive irinotecan hydrochloride as in arm A.
Patients receive erlotinib hydrochloride and panitumumab as in arm B.