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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: | NCT00903734 |
The goal of this screening portion of this clinical research study is to learn if you are eligible to take part in a clinical research study using Tarceva (erlotinib hydrochloride) and either Erbitux (cetuximab), Velcade (bortezomib), or Sprycel (dasatinib).
If the results of the screening portion of this clinical research study show that you are eligible to take part in one of the studies described above, the study drug that you will be assigned to take will depend on the results of biomarker analysis performed as a part of the screening tests described below. Biomarkers are chemical "markers" in the blood/tissue that may be related to how your body might react to the study drug.
Primary Objectives:
I. Determine reasonable dose of combination treatments, including Maximum Tolerated Dose (MTD) and toxicity profiles, via a brief initial "run-in"/dose escalation.
II. Evaluate response in patients with tumors that demonstrate EGFR-sensitive mutations, to treatment with single-agent erlotinib
III. Evaluate response in patients with tumors that demonstrate EGFR-resistant mutations, or patients who have previously demonstrated a response to EGFR inhibitors with subsequent resistance, to treatment with erlotinib combinations.
Condition | Intervention | Phase |
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Advanced Cancers |
Drug: Erlotinib Hydrochloride (Tarceva) |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Umbrella Protocol for Histology-Independent, Phase I Modular Study Based on Epidermal Growth Factor Receptor (EGFR) Mutation Status: Using Erlotinib Alone or in Combination With Cetuximab, Bortezomib, or Dasatinib to Overcome Resistance |
Estimated Enrollment: | 102 |
Study Start Date: | May 2009 |
Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Erlotinib Hydrochloride: Experimental
If found to be eligible for umbrella of studies and have not received Erlotinib hydrochloride in the past, will first receive Erlotinib hydrochloride alone.
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Drug: Erlotinib Hydrochloride (Tarceva)
Dose of 150 mg daily by mouth.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jennifer Wheler, MD | 713-563-1930 |
United States, Texas | |
UT MD Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: Jennifer Wheler, MD |
Study Chair: | Jennifer Wheler, MD | UT MD Anderson Cancer Center |
Responsible Party: | UT MD Anderson Cancer Center ( Jennifer J. Wheler, MD / Assistant Professor ) |
Study ID Numbers: | 2007-0638 |
Study First Received: | May 14, 2009 |
Last Updated: | May 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00903734 History of Changes |
Health Authority: | United States: Institutional Review Board |
Metastatic Cancer Histology-independent EGFR Mutation EGFR inhibitor-sensitive mutation Erlotinib Hydrochloride |
Tarceva OSI-774 Cetuximab Bortezomib Dasatinib |
Erlotinib Dasatinib Bortezomib Cetuximab |
Neoplasm Metastasis Mitogens Protein Kinase Inhibitors |
Erlotinib Molecular Mechanisms of Pharmacological Action Mitosis Modulators Mitogens |
Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |