A Phase I/II Study of IXO With Bevacizumab in Patients With Metastatic Colorectal Cancer
NCT00819754
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
Adult Trials: 18+ Years
- 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.
- 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
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
Clinical Trials
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Los Angeles, California
- New York, New York
- Leuven,
- Toronto, Ontario
- Toulouse Cedex 9,
- Milano, MI
- Amsterdam,
- Barcelona, Catalunya
- Ottawa, Ontario
- Besançon,
- Grenoble,
- Grenoble,
- Pierre Benite,
- Pierre Benite,
- Saint-Priest-en-Jarez,
- Toulouse,
| 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:
| |||
| 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 | 23 | |||
| Original Estimated Enrollment ICMJE | 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:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| 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 |
| |||
| Investigators ICMJE |
| |||
| 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 | ||||