Avastin and Tarceva for Locally Advanced or Metastatic Non-Squamous Non-Small-Cell Lung Cancer
- (Phase I) To establish the maximum tolerated dose and dose-limiting toxicities of the combination of OSI-774 (Tarceva™) and rhuMAb VEGF (Avastin™) in patients with advanced Non-small-cell lung carcinoma (NSCLC).
- (Phase II) To assess response rate and tolerability of the regimen at the dose level established in the phase I portion of this study.
- (Phase I and II) To evaluate the pharmacokinetic interaction between the combination.
- (Phase I) To establish a phase II regimen of the OSI-774/ rhuMAb VEGF combination, for further study alone or in combination with cytotoxic chemotherapy.
|Study Design:||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|
- Maximum Tolerated Dose (MTD) of Tarceva in combination with Avastin [ Time Frame: After each 21 day cycle ] [ Designated as safety issue: Yes ]
- Response in Patients With NSCLC Receiving Combination Avastin and Tarceva [ Time Frame: 6 weeks (2 cycles) ] [ Designated as safety issue: No ]
|Study Start Date:||August 2002|
|Study Completion Date:||May 2006|
|Primary Completion Date:||May 2006 (Final data collection date for primary outcome measure)|
Experimental: Avastin + Tarceva
Combination Therapy (Avastin + Tarceva) = Avastin IV Day 1 of each 21-day cycle + oral Tarceva daily.
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
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.
|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|