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

NCT00819754

Last updated date
Study Location
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, K1H 8L6, Canada
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

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[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Metastatic Colorectal Cancer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

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[email protected]

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Phase I/II Study of IXO With Bevacizumab in Patients With Metastatic Colorectal Cancer
Official Title  ICMJE A Phase I/II Clinical Trial of Combination of Irinotecan, Xeloda and Oxaliplatin (IXO) Regimen With Avastin (Bevacizumab) in Patients With Metastatic Colorectal Cancer
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Colorectal Cancer
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: IXO regimen + bevacizumab
This is phase I/II safety and efficacy study. There is only one arm of Irinotecan, Xeloda and Oxaliplatin (IXO) regimen with Avastin (bevacizumab)
Intervention: Drug: IXO regimen + bevacizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 10, 2014)
23
Original Estimated Enrollment  ICMJE
 (submitted: January 8, 2009)
54
Actual Study Completion Date  ICMJE May 2012
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00819754
Other Study ID Numbers  ICMJE 0TT 03-03
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ottawa Hospital Research Institute
Study Sponsor  ICMJE Ottawa Hospital Research Institute
Collaborators  ICMJE
  • Hoffmann-La Roche
  • Pfizer
  • Sanofi
  • Ottawa Regional Cancer Foundation
Investigators  ICMJE
Principal Investigator:Jean Maroun, MDThe Ottawa Hospital Cancer Centre
PRS Account Ottawa Hospital Research Institute
Verification Date January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP