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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborators: |
Genentech Vanderbilt-Ingram Cancer Center |
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00043823 |
Purpose
Primary Objectives:
Secondary Objectives:
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: Avastin Drug: Tarceva |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
|---|---|
|
Experimental: Avastin + Tarceva
Combination Therapy (Avastin + Tarceva) = Avastin IV Day 1 of each 21-day cycle + oral Tarceva daily.
|
Drug: Avastin
7.5 mg/kg By Vein on Day 1 of Every 21 Day Cycle
Other Names:
Drug: Tarceva
100 mg By Mouth Daily for 3 Weeks
Other Names:
|
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | Roy S. Herbst, M.D., PhD/Professor, University of Texas M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00043823 History of Changes |
| Other Study ID Numbers: | ID01-604, VICC THO 0206 |
| Study First Received: | August 14, 2002 |
| Last Updated: | April 7, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Non-Small Cell Lung Cancer NSCLC Lung Cancer Avastin Bevacizumab |
rhuMAb VEGF Anti-VEGF monoclonal antibody Tarceva OSI-774 Erlotinib Hydrocholoride |
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Antibodies Immunoglobulins Antibodies, Monoclonal Bevacizumab |
Erlotinib Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents Therapeutic Uses Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |