This phase I/II trial studies the side effects and best dose of 6,8-bis(benzylthio)octanoic acid (CPI-613) when given together with docetaxel and to see how well they work in treating patients with stage IIIB or IV non-small cell lung cancer. Drugs used in chemotherapy, such as CPI-613 and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
PRIMARY OBJECTIVES: I. To determine the maximum tolerate dose (MTD) of CPI-613 when used in combination with docetaxel therapy in advanced stage non-small cell lung cancer (NSCLC). (Phase1) II. To evaluate the response rate in patients receiving CPI-613 in combination with docetaxel therapy. (Phase 2) SECONDARY OBJECTIVES: I. To determine the safety of CPI-613 addition to docetaxel therapy. II. To determine the progression-free survival with CPI-613 in combination with docetaxel therapy at 27 weeks. III. To determine the median progression-free survival with CPI-613 in combination with docetaxel therapy. OUTLINE: This is a phase I, dose-escalation study of CPI-613 followed by a phase II study. Patients receive CPI-613 intravenously (IV) over 2 hours on days 1 and 3, and docetaxel IV on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients that achieve stable disease after 6 courses then receive CPI-613 alone on days 1and 3. Courses repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days and then periodically for 2 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, United States
Phase II dose of 6,8-bis(benzylthio)octanoic acid (CPI-613) when administered in combination with a standard dose of docetaxel (Phase 1)
Time frame: Up to 18 weeks
Response rate defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (Phase 2)
Will estimate the proportion of patients with a response (complete response + partial response) and calculate a 95% confidence interval for this measure.
Time frame: Up to 2 years
Median progression-free survival (PFS)
Will estimate the median PFS using standard survival methods (Kaplan Meier).
Time frame: From the start of treatment to the time of progression or death, assessed up to 2 years
Number and degree of adverse events under the experimental therapy regimens graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03
Will be estimated along with 95% confidence intervals for each adverse event. These estimates will be compared (not using specific statistical tests, but descriptively) to those reported in patients treated with docetaxel.
Time frame: Up to 30 days after the last study drug is administered
Overall survival (OS)
Time frame: From the start of treatment to date of death, assessed up to 2 years
Progression-free survival (PFS)
Time frame: From the start of treatment to the time of progression or death, assessed at 27 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.