Clinical trial NCT00819754: A Phase I/II Study of IXO With Bevacizumab in Patients With Metastatic Colorectal Cancer
Official title: A Phase I/II Clinical Trial of Combination of Irinotecan, Xeloda and Oxaliplatin (IXO) Regimen With Avastin (Bevacizumab) in Patients With Metastatic Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Metastatic Colorectal Cancer
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Hoffmann-La Roche
name: Pfizer
name: Sanofi
name: Ottawa Regional Cancer Foundation
First posted: 2009-01-09
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 (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.


Eligibility 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

Primary outcomes:
measure: Phase I: Assess the MTD and RD for phase II of IXO and bevacizumab combination given every 3 weeks in 1st line patients with mCRC
timeFrame: 3-week cycle, continuous monitoring of AE
measure: Phase II: Using the RD established in phase I, assess efficacy of the IXO with bevacizumab combination as measured by progression-free survival
timeFrame: 3-week cycle, continuous monitoring of AE
Secondary outcomes:
measure: Response rates and duration of response
timeFrame: every 2 cycles - 6 weeks
measure: Overall survival
timeFrame: continuous
measure: Qualitative and quantitative toxicity
timeFrame: continuous
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital Cancer Centre
state: Ontario
Study officials:
affiliation: The Ottawa Hospital Cancer Centre
name: Jean Maroun, MD
role: PRINCIPAL_INVESTIGATOR
References: