Study of REOLYSIN® in Combination With FOLFIRI in Patients With Oxaliplatin Refractory/Intolerant KRAS Mutant Colorectal Cancer

Inclusion Criteria: Each patient MUST:

• Have histologically confirmed cancer of the colon or rectum with radiologically documented and measurable metastases (high CEA alone is insufficient for study entry).
• Have received 3 or fewer regimens in the metastatic setting.
• Have his/her tumor assessed for KRAS status and found to be mutation positive.
• Have NO continuing acute toxic effects (except alopecia) of any prior radiotherapy, chemotherapy, or surgical procedures, i.e., all such effects must have resolved.
• Have an ECOG Performance Score of ≤ 2.
• Have a life expectancy of at least 3 months.

• Have baseline laboratory results as follows:

  • Absolute neutrophil count (ANC) ≥ 1.5 x 10^9 [SI unit 10^9/L]
  • Platelets ≥ 100 x10^9 [SI units 10^9/L] (without platelet transfusion)
  • Hemoglobin ≥ 9.0 g/dL [SI units gm/L] (with or without RBC transfusion)
  • Serum creatinine ≤ 1.5 x upper limit of normal (ULN)
  • Bilirubin ≤ ULN
  • AST/ALT ≤ 2.5 x ULN (≤ 5 x ULN if with liver metastases)
  • Negative pregnancy test for females with childbearing potential.
• Have signed an informed consent indicating that the patient is aware of the neoplastic nature of their disease and have been informed of the procedures of the protocol, the experimental nature of the therapy, alternatives, potential benefits, side effects, risks, and discomforts.
• Be willing and able to comply with scheduled visits, the treatment plan, and laboratory tests.

Exclusion Criteria: No patient may:

• Receive concurrent therapy with any other investigational anticancer agent while on study.
• Have received more than 3 chemotherapy regimens in the metastatic setting.
• Have brain metastases.
• Be on immunosuppressive therapy or have known HIV infection or active hepatitis B or C.
• Have received chemotherapy, radiotherapy, immunotherapy or hormonal therapy or had surgery (except biopsies) within 28 days prior to receiving the study drug.
• Be a pregnant or breast-feeding woman. Female patients of childbearing potential must agree to use effective contraception, be surgically sterile, or be postmenopausal. Male patients must agree to use effective contraception or be surgically sterile. Barrier methods are a recommended form of contraception.
• Have clinically significant cardiac disease (New York Heart Association, Class III or IV) including pre-existing arrhythmia, uncontrolled angina pectoris, myocardial infarction within 1 year prior to study entry, or Grade 2 or higher compromised left ventricular ejection fraction.
• Have dementia or altered mental status that would prohibit informed consent.
• Have any other acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the Principal Investigator, would make the patient inappropriate for this study.