NCT00819754

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2003

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

January 8, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 9, 2009

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

January 14, 2014

Status Verified

January 1, 2014

Enrollment Period

8.3 years

First QC Date

January 8, 2009

Last Update Submit

January 10, 2014

Conditions

Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (2)

  • 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

    3-week cycle, continuous monitoring of AE

  • Phase II: Using the RD established in phase I, assess efficacy of the IXO with bevacizumab combination as measured by progression-free survival

    3-week cycle, continuous monitoring of AE

Secondary Outcomes (3)

  • Response rates and duration of response

    every 2 cycles - 6 weeks

  • Overall survival

    continuous

  • Qualitative and quantitative toxicity

    continuous

Study Arms (1)

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)

Drug: IXO regimen + bevacizumab

Interventions

IXO regimen + bevacizumabDRUG

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

Also known as: irinotecan - Camptosar, capecitabine - Xeloda, Oxaliplatin - Eloxatin, bevacizumab - Avastin
IXO regimen + bevacizumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, K1H 8L6, Canada

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

BevacizumabCapecitabineOxaliplatin

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesCoordination ComplexesOrganic Chemicals

Study Officials

  • Jean Maroun, MD

    The Ottawa Hospital Cancer Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2009

First Posted

January 9, 2009

Study Start

November 1, 2003

Primary Completion

February 1, 2012

Study Completion

May 1, 2012

Last Updated

January 14, 2014

Record last verified: 2014-01

Locations

CA(1)