Trial | NCT00819754  Report issue

Title

A Phase I/II Study of IXO With Bevacizumab in Patients With Metastatic Colorectal Cancer
A Phase I/II Clinical Trial of Combination of Irinotecan, Xeloda and Oxaliplatin (IXO) Regimen With Avastin (Bevacizumab) in Patients With Metastatic Colorectal Cancer

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    23
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.
Study Started
Nov 30
2003
Primary Completion
Feb 29
2012
Study Completion
May 31
2012
Last Update
Jan 14
2014
Estimate

Drug IXO regimen + bevacizumab

Phase I study - identifies the safety of IXO with bevacizumab and recommended phase II dose Phase II study - assesses efficacy and safety of IXO with bevacizumab

  • Other names: irinotecan - Camptosar, capecitabine - Xeloda, Oxaliplatin - Eloxatin, bevacizumab - Avastin

IXO regimen + bevacizumab Experimental

This is phase I/II safety and efficacy study. There is only one arm of Irinotecan, Xeloda and Oxaliplatin (IXO) regimen with Avastin (bevacizumab)

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
No Results Posted