Multi Center, Open Label, Single Arm Trial Evaluating Panitumumab in Combination With FOLFIRI Therapy Following First Line FOLFOX and Bevacizumab Treatment of Metastatic Colorectal Cancer
Inclusion Criteria:
- Diagnosis of metastatic adenocarcinoma of the colon or rectum
- Available paraffin-embedded tumor tissue
- Failure of first line treatment containing fluoropyrimidine and oxaliplatin based
chemotherapy with bevacizumab for mCRC
- Measurable disease
- Adequate hematologic, renal, hepatic and metabolic function
Exclusion Criteria:
- Radiotherapy ≤ 2 weeks prior to Day 1 of Cycle 1
- Unresolved toxicity(ies) from prior anti cancer therapy that, in the opinion of the
investigator, precludes the subject from study enrollment
- Prior irinotecan therapy. anti EGFr therapy, or vaccine for the treatment of mCRC
- CYP3A4 enzyme inducers, inhibitors, and substrates (eg, phenytoin, phenobarbital,
carbamazepine, ketoconazole, rifampin, rifabutin, and St. John's Wort) ≤ 2 weeks
prior to Day 1 of Cycle 1
- Infection requiring systemic anti infectives completed ≤ 2 weeks prior to Day 1 of
Cycle 1
- Clinically significant cardiovascular disease
- History of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis)
- Pulmonary embolism, deep vein thrombosis, or other significant thromboembolic event ≤
8 weeks prior to Day 1 of Cycle 1
- Any significant bleeding ≤6 weeks prior to Day 1 of Cycle 1, per the investigator's
judgement
- Gastroduodenal ulcer(s) determined by endoscopy to be active or uncontrolled
gastrointestinal ulcer ≤ 4 weeks prior to Day1 of Cycle 1
- Any co morbid disease or condition that could increase the risk of toxicity (eg,
dihydropyrimidine deficiency, significant ascites, or pleural effusion)
- Major surgery (requiring general anesthesia), open biopsy, or significant traumatic
injury ≤4 weeks prior to Day1 of Cycle 1. Subjects must have recovered from surgery
and have no significant complications