Overview

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