Status:
COMPLETED
Phase I Trial of Sorafenib + FOLFIRI In Metastatic Colorectal Cancer
Lead Sponsor:
Ottawa Hospital Research Institute
Collaborating Sponsors:
Bayer
Conditions:
Metastatic Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 (...
Detailed Description
A standard phase I dose escalation design with three to six patients per dose level will be used. The first three patients will receive chemotherapy at the dose level 1 for 4 weeks (2 FOLFIRI regimen)...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00780169
Start Date
October 1 2008
End Date
December 1 2012
Last Update
May 13 2013
Active Locations (1)
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1
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada, K1H 8L6