This phase I trial studies the side effects and the best dose of Hsp90 inhibitor AUY922 when given together with pemetrexed disodium in treating patients with previously treated stage IV non-small cell lung cancer. Hsp90 inhibitor AUY922 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as pemetrexed disodium, work in different ways to stop the growth of tumor cell, either by killing the cells or stopping them from dividing. Giving Hsp90 inhibitor AUY922 together with pemetrexed disodium may kill more tumor cells
PRIMARY OBJECTIVES: I. Evaluate the safety and tolerability of escalating doses of AUY922 (Hsp90 inhibitor AUY922) when given with pemetrexed (pemetrexed disodium) 500 mg/m\^2 in participants with previously-treated stage IV non-squamous, non-small cell lung cancer (NSCLC). SECONDARY OBJECTIVES: I. Determine the objective tumor response rate as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria in participants with previously treated non-squamous NSCLC treated with pemetrexed and AUY922. II. Evaluate the pharmacokinetic profile of pemetrexed and AUY922. III. Evaluate toxicity, including visual toxicity, in participants treated with AUY922 and pemetrexed. IV. Analyze tumor-tissue biomarkers for potential correlation with response. OUTLINE: This is a dose-escalation study of Hsp90 inhibitor AUY922. Patients receive Hsp90 inhibitor AUY922 intravenously (IV) over 60 minutes weekly and pemetrexed disodium IV over 15 minutes every 3 weeks. Courses repeat every 21 days for 6 months in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
13
Given IV
Given IV
Correlative studies
Correlative studies
Jonsson Comprehensive Cancer Center
Los Angeles, California, United States
Incidence of adverse events (AEs) as assessed by National Cancer Institute (NCI) CTCAE version 4.0
Safety will be assessed through tabulation, grading and attribution of serious adverse events (SAEs) and AEs.
Time frame: Up to 30 days after completion of study treatment
Tumor response rate according to RECIST version 1.1
The proportion of ever achieving a clinical response will be estimated and constructed with an exact one-sided 90% confidence interval to identify the likely range for the underlying tumor response rate. Clinical response will be correlated with biomarkers using a variety of analytic techniques.
Time frame: Up to 30 days after completion of study treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.