A Phase I/II Study of IXO With Bevacizumab in Patients With Metastatic Colorectal Cancer

• Status: Terminated
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

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 (mCRC). The oral fluoropyrimidine, capecitabine, is better tolerated and shows better response rates than 5-FU/LV in metastatic colorectal cancer. A phase I dose-escalation study established dose limiting toxicity (DLT), maximum tolerated dose (MTD) and recommended phase II doses (RPIID) of irinotecan, oxaliplatin and capecitabine. This phase I /II study is to determine dose-limiting toxicities (DLTs), maximum tolerated dose (MTD), phase II recommended dose (RD) of IXO and bevacizumab combination and safety at the RD in an expanded cohort.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ottawa Hospital Research Institute
• Collaborators: Hoffmann-La Roche; Ottawa Regional Cancer Foundation; Pfizer; Sanofi
• Treatments: Bevacizumab; Capecitabine; Irinotecan; Oxaliplatin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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