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.
PRIMARY OBJECTIVES: I. To determine the 12-week progression-free survival rate of patients with extensive stage small cell lung cancer treated with AZD0530. SECONDARY OBJECTIVES: 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 IV. To determine the effect of AZD0530 treatment on levels of circulating tumor cells in these patients. V. To determine potential predictive markers of response in circulating tumor cells after treatment with this drug. VI. To evaluate the rate of tumor marker (i.e., circulating tumor cells) stabilization in patients treated with this drug. TERTIARY OBJECTIVES: I. To determine the effect of AZD0530 treatment on levels of circulating tumor cells. II. To determine potential predictive markers of response in circulating tumor cells after treatment with this drug. III. To evaluate the rate of tumor marker (i.e., circulating tumor cells) stabilization in patients treated with this drug. OUTLINE: 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. After completion of study therapy, patients are followed periodically for up to 2 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
23
Given orally
North Central Cancer Treatment Group
Rochester, Minnesota, United States
Progression-free Survival Rate at 12 Weeks
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 and multiplied by 100. 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. Progression is defined using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Progression is defined as having a new lesion or having at least a 20% increase in the sum of the longest diameter of target lesions from baseline.
Time frame: 12 weeks
Overall Survival
Overall Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.
Time frame: From registration to death due to any cause, assessed up to 2 years
Confirmed Tumor Response (Defined as Complete or Partial Response on 2 Consecutive Evaluations at Least 4 Weeks Apart)
Response was assessed using the RECIST v1.1 criteria. Patients were evaluated after every other cycle (after cycle 2, 4, 6, etc...) and when progression is suspected. A Complete Response (CR) is defined as the disappearance of all target lesions. A Partial Response (PR) is defined as at least a 20% decrease in the sum of the longest diameter of target lesions from baseline. A confirmed response is defined as a CR or PR as the objective status on 2 consecutive evaluations at least 4 weeks apart..
Time frame: After every other 21-day cycle, up to 2 years.
Progression Free Survival
Progression Free Survival (PFS) is defined as the time from registration to documentation of disease progression or death, whichever occurs first. The distribution of time to progression will be estimated using the method of Kaplan-Meier.
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Time frame: From registration to documentation of disease progression or death, assessed up to 2 years