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Sponsored by: |
M.D. Anderson Cancer Center |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00761644 |
Primary objective:
To determine the maximum tolerated doses (MTDs) and dose-limiting toxicities (DLTs) of combination treatment with doxil, bevacizumab and temsirolimus.
Secondary objectives:
Condition | Intervention | Phase |
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Advanced Cancer |
Drug: Doxil Drug: Bevacizumab Drug: Temsirolimus Procedure: CT or MRI Scan |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Efficacy Study |
Official Title: | A Phase I Trial of Doxil, Bevacizumab and Temsirolimus |
Estimated Enrollment: | 46 |
Study Start Date: | August 2008 |
Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Doxil, Bevacizumab and Temsirolimus
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Drug: Doxil
Day 1 of each 21 day cycle, beginning dose level 10 mg/m^2 by IV over 3 hours
Drug: Bevacizumab
Day 1 of each 21 day cycle, beginning dose level 5 mg/kg by IV over 90 minutes
Drug: Temsirolimus
Days 1, 8 & 15 of 21 Day Cycle, beginning dose level 12.5 mg by IV over 30 to 60 minutes
Procedure: CT or MRI Scan
Starting after Cycle 2, disease status checked by CT or MRI scan after every 2 cycles
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Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion:
Exclusion:
Contact: Razelle Kurzrock, MD, BS | 713-563-1930 |
United States, Texas | |
UT MD Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: Razelle Kurzrock, MD, BS |
Principal Investigator: | Razelle Kurzrock, MD, BS | UT MD Anderson Cancer Center |
Responsible Party: | UT MD Anderson Cancer Center ( Razelle Kurzrock MD, BS/Professor ) |
Study ID Numbers: | 2008-0384 |
Study First Received: | September 25, 2008 |
Last Updated: | September 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00761644 |
Health Authority: | United States: Institutional Review Board |
metastatic cancer |
Antibodies, Monoclonal Antibodies Neoplasm Metastasis |
Bevacizumab Doxorubicin Immunoglobulins |
Antineoplastic Agents Growth Substances Therapeutic Uses Physiological Effects of Drugs Growth Inhibitors |
Angiogenesis Modulating Agents Antibiotics, Antineoplastic Angiogenesis Inhibitors Pharmacologic Actions |