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
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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose (MTD) of Tarceva in combination with Avastin
After each 21 day cycle
Yes
Roy S. Herbst, MD, PhD
Principal Investigator
M.D. Anderson Cancer Center
United States: Food and Drug Administration
ID01-604
NCT00043823
August 2002
May 2006
Name | Location |
---|---|
Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
University of Texas M.D. Anderson Cancer Center | Houston, Texas 77030 |