Study of Erlotinib With Docetaxel in Selected Non Small Cell Lung Cancer Patients in First Line Treatment
There is increasing evidence that erlotinib improves overall survival in selected patients with stage IIIB-IV NSCLC. Furthermore, pre-clinical and phase II studies have shown a potential for synergism between erlotinib and docetaxel. This study will further evaluate the effects of combination treatment on overall survival in selected NSCLC patient population.
Based on recent published data, the treatment cycle in this study will be 22 days with two infusions (Day 1 and Day 8 of each cycle). This is different from the standard therapy care of 28-day cycle (three infusions on Days 1, 8 and 15). The shorter 22-day cycle was shown to be just as effective as the 28-day cycle and is expected to increase subject compliance and decrease chemotherapy-induced toxicity.
The primary objective is to demonstrate superiority in progression-free-survival, when erlotinib is added to docetaxel.
The secondary objectives are to determine:
- Overall survival (defined as the time period from the start of first-line therapy to death)
- Time to treatment failure or disease progression (defined as the time period from the start of first-line therapy to investigator assessed disease progression)
- Tumor response rate and duration
- Safety profile
- Quality of Life improvement
- microRNA profile (assessed from human lung biopsy and/or cytology samples) at screening for prognostic purposes
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Open-Label Study Designed to Evaluate the Efficacy and Safety, of Erlotinib in Combination With Docetaxel in Selected Non Small Cell Lung Cancer Patients Eligible for First Line Treatment|
- all cause mortality [ Time Frame: 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||February 2009|
|Study Completion Date:||August 2011|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
docetaxel + erlotinib
150mg tablet daily
Other Name: tarcevaDrug: docetaxel
30 mg/m2 days 1,8 of 22 days cycles, up to 6 cycles
Other Name: taxotere
This will be a Phase II, open-label, single-center, repeat dose, study. After a two-week screening phase, eligible subjects will receive combined docetaxel and erlotinib treatment over six cycles. Each 22-day treatment cycle will consist of two infusion of docetaxel, one-week apart followed by one week rest, and daily administration of erlotinib. Subjects, who complete six cycles of combination therapy, will continue receiving erlotinib monotherapy for as long as they are benefiting from this therapy in the opinion of the investigator (i.e. until continued toxicity or disease progression or withdrawal from the study). Subjects will be evaluated for safety and radiologic tumor assessment throughout the study until death. The study will be terminated after every living patient has had a follow up of at least 6 months after stopping TarcevaTM, or when all patients have died.