Selumetinib and Erlotinib Hydrochloride in Patients With Advanced Non-Small Cell Lung Cancer
| Status: | Archived |
|---|---|
| Conditions: | Lung Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | October 2010 |
Randomized Phase II Study of AZD6244 (Mitogen-activated Protein Kinase Inhibitor) MEK-Inhibitor With Erlotinib in KRAS Wild Type Advanced Non-Small Cell Lung Cancer (NSCLC) and a Randomized Phase II Study of AZD6244 With Erlotinib in Mutant KRAS Advanced NSCLC
RATIONALE: Selumetinib and erlotinib hydrochloride may stop the growth of tumor cells by
blocking some of the enzymes needed for cell growth. It is not yet known whether giving
selumetinib together with erlotinib hydrochloride is more effective than giving selumetinib
alone or erlotinib hydrochloride alone for non-small cell lung cancer.
PURPOSE: This randomized phase II trial is studying how well giving selumetinib together
with or without erlotinib hydrochloride works in treating patients with advanced non-small
cell lung cancer.
OBJECTIVES:
Primary
- To determine the progression-free survival (PFS) of patients with wild-type K-RAS
advanced non-small cell lung cancer (NSCLC) treated with a combination of selumetinib
and erlotinib hydrochloride.
- To determine the clinical response rate in patients with K-RAS mutant advanced NSCLC
using selumetinib monotherapy or the combination of selumetinib and erlotinib
hydrochloride.
Secondary
- To evaluate for clinical response rate and disease control rate in patients with
wild-type K-ras advanced NSCLC.
- To evaluate the PFS and disease control rate in patients with mutated K-RAS advanced
NSCLC.
- To determine the safety profile of selumetinib in combination with erlotinib
hydrochloride in patients with advanced NSCLC.
- To measure changes in a tumor's MIB-1 (Ki-67) rate and pERK levels in response to
selumetinib as monotherapy or in combination with erlotinib hydrochloride.
- To evaluate and correlate a patient's response to treatment with histological and
molecular testing of the patient's tumor.
- To measure serological markers and evaluate if these markers are correlated with tumor
response.
- To evaluate overall survival (OS) of patients being treated on this trial.
OUTLINE: This is a multicenter study. Patients are stratified according to K-RAS mutation
status (wild-type vs mutant). Patients are randomized to 1 of 4 treatment arms.
- Arm I (K-ras wild-type): Patients receive oral selumetinib once daily and oral
erlotinib hydrochloride once a day on days 1-28.
- Arm II (K-ras wild-type): Patients receive oral erlotinib hydrochloride once a day on
days 1-28.
- Arm III (mutated K-ras): Patients receive selumetinib and erlotinib hydrochloride as in
arm I.
- Arm IV (mutated K-ras): Patients receive oral selumetinib twice daily on days 1-28.
In all arms, courses repeat every 28 days in the absence of disease progression or
unacceptable toxicity.
Archived tumor tissue and blood samples collected at baseline and at weeks 1 and 2 are
analyzed for MIB-1 (Ki-67) rate and pERK levels by IHC. Patients may also undergo tumor
tissue collection by surgery or needle biopsies for MIB-1 (Ki-67) and pERK analyzes.
After completion of study treatment, patients are followed up at 30 days and then every 3
months thereafter.
We found this trial at
1
site
National Cancer Institute (NCI) The National Cancer Institute (NCI) is part of the National Institutes...
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