Status:
TERMINATED
A Phase I/II Study of IXO With Bevacizumab in Patients With Metastatic Colorectal Cancer
Lead Sponsor:
Ottawa Hospital Research Institute
Collaborating Sponsors:
Hoffmann-La Roche
Pfizer
Conditions:
Metastatic Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Triplets of irinotecan, oxaliplatin and infusional 5-fluorouracil(FU)/leucovorin (LV) are associated with high response rates and long survival as first-line treatment for metastatic colorectal cancer...
Eligibility Criteria
Inclusion
- Histologically documented adenocarcinoma of the colon or rectum.
- Advanced and/or metastatic disease, incurable with standard therapy.
- Unresectable advanced and/or metastatic unidimensionally measurable disease (RECIST scale).
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
- Age: over 18 years.
- Adequate haematological, renal and hepatic functions
- Patient consent must be obtained according to local REB requirements.
- Patients must be accessible for treatment and follow up.
Exclusion
- Previous or concurrent malignancies
- Pregnant or lactating women. Women of childbearing potential must have had a negative pregnancy test within 7 days prior to registration.
- Concurrent treatment with other experimental drugs or anticancer therapy.
- Previous chemotherapy for advanced and/or metastatic disease.
- Previous adjuvant therapy with irinotecan or oxaliplatin.
- Previous full dose curative pelvic radiation therapy.
- Patients with documented brain metastases.
- Serious illness or medical condition.
- Gilbert's disease
- Use of enzyme inducing anticonvulsants such as phenytoin, phenobarbital and carbamazepine
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00819754
Start Date
November 1 2003
End Date
May 1 2012
Last Update
January 14 2014
Active Locations (1)
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1
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada, K1H 8L6