A Phase I/II Study of IXO With Bevacizumab in Patients With Metastatic Colorectal Cancer
NCT00819754
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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
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| 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:
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| Sex/Gender ICMJE |
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| 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 |
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| Investigators ICMJE |
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| 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 | ||||