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Sponsors and Collaborators: |
M.D. Anderson Cancer Center Genentech Vanderbilt-Ingram Cancer Center |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00043823 |
Patients will be treated with oral Tarceva daily for 21 days each cycle. Patients will receive Avastin by IV on day 1 of each 21-day cycle. If a patient has no grade 3 or 4 toxicities after the 1st cycle, then the patient may continue the same doses of Tarceva and Avastin for another cycle. If the patient has response or stable disease after 6 weeks (2 cycles), the patient may continue on the same doses of Tarceva and Avastin. A patient may receive treatment on this study for up to one year, unless his or her disease progresses or side effects become too severe.
The starting dose is 100 mg daily of Tarceva and 7.5 mg/kg every 21 days of Avastin.
Condition | Intervention | Phase |
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Lung Cancer |
Drug: Avastin Drug: Tarceva |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Safety and Efficacy of Recombinant Humanized Monoclonal Anti-VEGF Antibody rhuMAb VEGF and EGFR Tyrosine Kinase Inhibitor OSI-774 for Locally Advanced or Metastatic Non-Squamous Cell NSCLC in Patients Who Have Been Previously Treated |
Enrollment: | 41 |
Study Start Date: | August 2002 |
Study Completion Date: | May 2006 |
Primary Completion Date: | May 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Avastin + Tarceva
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Drug: Avastin
7.5 mg/kg IV on Day 1 of Every 21 Day Cycle
Drug: Tarceva
100 mg PO Daily for 3 Weeks
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Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion:
Exclusion:
United States, Tennessee | |
Vanderbilt-Ingram Cancer Center | |
Nashville, Tennessee, United States, 37232 | |
United States, Texas | |
University of Texas M.D. Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Roy S. Herbst, MD, PhD | U.T.M.D. Anderson Cancer Center |
Responsible Party: | University of Texas M.D. Anderson Cancer Center ( Roy S. Herbst, M.D., PhD/Professor ) |
Study ID Numbers: | ID01-604, VICC THO 0206 |
Study First Received: | August 14, 2002 |
Last Updated: | January 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00043823 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Non-Small Cell Lung Cancer Lung Cancer Avastin Tarceva |
NSCLC OSI-774 rhuMAb VEGF |
Thoracic Neoplasms Erlotinib Tyrosine Bevacizumab Protein Kinase Inhibitors Angiogenesis Inhibitors Carcinoma Antibodies |
Respiratory Tract Diseases Lung Neoplasms Lung Diseases Non-small Cell Lung Cancer Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Immunoglobulins |
Thoracic Neoplasms Erlotinib Respiratory Tract Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Enzyme Inhibitors Bevacizumab Protein Kinase Inhibitors Angiogenesis Inhibitors |
Pharmacologic Actions Carcinoma Neoplasms Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Lung Diseases Growth Inhibitors Angiogenesis Modulating Agents Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |