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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborators: |
Cephalon National Comprehensive Cancer Network |
| Information provided by (Responsible Party): | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01152203 |
Purpose
The goal of this clinical research study is to find the highest tolerable combination dose of bendamustine and bevacizumab that can be given to patients with advanced cancer. The safety of the drug combination will also be studied.
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Cancer |
Drug: Bendamustine Drug: Bevacizumab |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Study of Bendamustine and Bevacizumab for Patients With Advanced Cancers |
| Estimated Enrollment: | 55 |
| Study Start Date: | June 2010 |
| Estimated Primary Completion Date: | June 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Bendamustine + Bevacizumab |
Drug: Bendamustine
Starting dose of 70 mg/m^2 by vein on Days 1 and 2 of a 28 day cycle
Other Names:
Drug: Bevacizumab
10 mg/kg by vein on Days 1 & 15 of every 28 day cycle
Other Names:
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Show Detailed Description
Eligibility| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Apostolia M. M. Tsimberidou, MD, PhD | 713-792-4259 |
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Apostolia M. Tsimberidou, MD, PhD | |
| Study Chair: | Apostolia M. Tsimberidou, MD, PhD | UT MD Anderson Cancer Center |
More Information
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01152203 History of Changes |
| Other Study ID Numbers: | 2009-0979 |
| Study First Received: | June 25, 2010 |
| Last Updated: | March 15, 2012 |
| Health Authority: | United States: Institutional Review Board |
|
Bendamustine Bevacizumab |
|
Neoplasms Antibodies, Monoclonal Bendamustine Bevacizumab Nitrogen Mustard Compounds Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents |
Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |