Phase I Trial of Sorafenib + FOLFIRI In Metastatic Colorectal Cancer

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the safety, the maximum tolerated dose and the recommended dose for phase II studies of a chemotherapy-combination of sorafenib, irinotecan, and 5-fluorouracil (5-FU)/folinic acid (FA) (FOLFIRI) as first-line treatment for metastatic colorectal cancer.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ottawa Hospital Research Institute
• Collaborator: Bayer
• Treatments: Niacinamide; Sorafenib

Criteria

Inclusion Criteria:

• Metastatic colorectal cancer

• Histopathological verification of the primary tumor

• Measurable disease according to RESIST criteria

• Response Evaluation Criteria in Solid Tumors (ECOG) performance status ≤ 2

• Age > 18 years.

• Women of childbearing potential must have had a negative pregnancy test within 7 days prior to start of treatment. Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.

• Patients may have had prior adjuvant chemotherapy with fluoropyrimidines WITHOUT pelvic radiotherapy.

• Radiation: Patients may have had prior palliative radiation therapy to NO more than 50% of the areas bearing of bone marrow stores.

• Adequate organ and marrow function : Hemoglobin > 9.0 g/dl; absolute neutrophil count (ANC) >1,500/mm3; absolute granulocyte count(AGC) > 1.5 x 109 /L; Platelets > 100 x 109 /L; Serum creatinine and creatinine clearance within upper normal limit; Bilirubin < 1.0 x upper normal limit, < 2.5 x upper normal limit if documented liver metastases; aspartate aminotransferase (AST) < 2.5 x upper normal limit, < 5 x upper normal limit if documented liver metastases

• Life expectancy > 3 months

• Informed consent

Exclusion Criteria:

• Previous or concurrent malignancies

• Patients with central nervous system (CNS) metastases

• Pregnant or lactating women

• Concurrent treatment with other experimental drugs or anticancer therapy

• Previous chemotherapy for advanced and/or metastatic disease

• Previous adjuvant therapy with irinotecan or targeted agents

• Previous Sorafenib therapy

• Previous full dose curative pelvic radiotherapy

• History of cardiovascular disease, cerebral ischemia infarction or hemorrhage, Gilbert's disease, HIV positivity

• Unable to be compliant with the procedures in the protocol

• Currently use prohibited medications