AZD0530 in Treating Patients With Extensive Stage Small Cell Lung Cancer
AZD0530 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This phase II study is studying how well giving AZD0530 works in treating patients with extensive-stage small cell lung cancer.
Extensive Stage Small Cell Lung Cancer
Malignant Pleural Effusion
Recurrent Small Cell Lung Cancer
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of the c-SRC Inhibitor AZD0530 After Four Cycles of Cytoreductive Chemotherapy for Patients With Extensive Stage Small Cell Lung Carcinoma|
- Progression-free Survival Rate at 12 Weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]The progression-free survival (PFS) rate at 12 weeks will be estimated by calculating the number of patients that are alive and progression-free at 12 weeks post-registration divided by the total number of evaluable patients. All patients meeting the eligibility criteria who have signed a consent form, begun AZD0530 treatment, and are not lost to follow-up before 12 weeks, will be considered evaluable for the 12-week progression-free survival (PFS) rate.
- Survival Time [ Time Frame: From registration to death due to any cause, assessed up to 2 years ] [ Designated as safety issue: No ]Will be estimated using the method of Kaplan-Meier.
- Confirmed Tumor Response (Defined as Complete or Partial Response on 2 Consecutive Evaluations at Least 4 Weeks Apart) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Confirmed tumor response (complete and partial) as measured by RECIST(Response Evaluation Criteria In Solid Tumors) criteria on 2 consecutive evaluations at least 4 weeks apart.
Confirmed tumor response is at least a 30% decrease in the sum of the longest diameter of target lesions and no new lesions.
- Time to Disease Progression [ Time Frame: From registration to documentation of disease progression, assessed up to 2 years ] [ Designated as safety issue: No ]Will be estimated using the method of Kaplan-Meier.
|Study Start Date:||November 2007|
|Primary Completion Date:||November 2008 (Final data collection date for primary outcome measure)|
Experimental: Treatment (saracatinib)
Patients receive oral AZD0530 once daily for up to 2 years in the absence of disease progression or unacceptable toxicity. Blood samples are obtained at baseline and periodically during study to determine levels of circulating tumor cells for defined translational studies.
saracatinib 175mg given orally daily with re-treatment every 3 weeks
I. To determine the 12-week progression-free survival rate of patients with extensive stage small cell lung cancer treated with AZD0530.
I. To determine the response rate in patients treated with this drug. II. To determine the overall survival and time-to-progression in patients treated with this drug.
III. To determine the adverse events of AZD0530 in these patients
OUTLINE: Patients receive oral AZD0530 once daily for up to 2 years in the absence of disease progression or unacceptable toxicity
After completion of study therapy, patients are followed periodically for up to 2 years.
|United States, Minnesota|
|North Central Cancer Treatment Group|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Julian Molina||North Central Cancer Treatment Group|