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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: | NCT00543504 |
Primary Objective:
-To determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLT) of bevacizumab when used in combinations with:
Secondary Objective:
Condition | Intervention | Phase |
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Advanced Cancer |
Drug: Bevacizumab Drug: Sorafenib Drug: Erlotinib Drug: Trastuzumab Drug: Lapatinib Drug: Sunitinib Drug: Cetuximab |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 1 Study of Bevacizumab in Combination With 1) Sunitinib, 2) Sorafenib, 3) Erlotinib and Cetuximab, 4) Trastuzumab and Lapatinib |
Estimated Enrollment: | 290 |
Study Start Date: | October 2007 |
Estimated Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Bevacizumab + Sunitinib
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Drug: Bevacizumab
2.5 mg/kg IV Over 90 Minutes.
Drug: Sunitinib
12.5 mg PO daily for 4 weeks, then 2 weeks off.
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2: Experimental
Bevacizumab + Sorafenib
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Drug: Bevacizumab
2.5 mg/kg IV Over 90 Minutes.
Drug: Sorafenib
200 mg PO Daily x 28 Days
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3: Experimental
Bevacizumab + Erlotinib + Cetuximab
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Drug: Bevacizumab
2.5 mg/kg IV Over 90 Minutes.
Drug: Erlotinib
50 mg PO Daily x 28 Days.
Drug: Cetuximab
100 mg/m^2 IV Weekly Over 2 Hours
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4: Experimental
Bevacizumab + Trastuzumab + Lapatinib
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Drug: Bevacizumab
2.5 mg/kg IV Over 90 Minutes.
Drug: Trastuzumab
2 mg/kg IV Once Every 3 Weeks
Drug: Lapatinib
250 mg PO Daily x 21 Days.
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Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Gerald Falchook, MD | 713-563-1930 |
United States, Texas | |
U.T.M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: Gerald Falchook, MD |
Principal Investigator: | Gerald Falchook, MD | U.T.M.D. Anderson Cancer Center |
Responsible Party: | U.T.M.D. Anderson Cancer Center ( Gerald Falchook, MD/Professor ) |
Study ID Numbers: | 2006-0638 |
Study First Received: | October 11, 2007 |
Last Updated: | November 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00543504 |
Health Authority: | United States: Institutional Review Board |
Advanced Cancer Bevacizumab Avastin Sorafenib BAY 43-9006 Erlotinib OSI-774 Tarceva Trastuzumab Herceptin |
Sunitinib SU011248 Sutent Cetuximab Lapatinib Anti-VEGF monoclonal antibody rhuMAb-VEGF Erlotinib hydrochloride GW572016 Sunitinib Malate |
Erlotinib Antibodies, Monoclonal Antibodies Sunitinib Cetuximab |
Trastuzumab Lapatinib Bevacizumab Sorafenib Immunoglobulins |
Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Growth Substances Therapeutic Uses Physiological Effects of Drugs |
Enzyme Inhibitors Growth Inhibitors Angiogenesis Modulating Agents Protein Kinase Inhibitors Angiogenesis Inhibitors Pharmacologic Actions |