CPI-613 and Docetaxel in Treating Patients With Stage IIIB or IV Non-small Cell Lung Cancer

• Status: Withdrawn
• Trial end date: 2020-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wake Forest University Health Sciences
• Collaborator: National Cancer Institute (NCI)
• Treatments: Docetaxel; Thioctic Acid

Criteria

Inclusion Criteria:

• Patients must have histologically or cytologically confirmed stage IIIB or IV NSCLC with radiographic proof of measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 criteria

• Eastern Cooperative Oncology Group (ECOG) status of 0 or 1

• Life expectancy of >= 3 months

• Patients must have received previous systemic therapy to include: a regimen of chemotherapy, immunotherapy including anti-PDL or anti-PD-L1 therapies, combined chemotherapy and immunotherapy, provided treatment was discontinued >= 2 weeks prior to initiation of treatment on the present protocol

• Absolute neutrophil count >= 1,500/uL

• Platelets >= 100,000/uL

• Total bilirubin within normal institutional limits

• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) within institutional upper limit of normal

• International normalized ratio (INR) =< 1.5 x upper limit of normal (ULN)

• Prothrombin time (PT) =< 1.5 x ULN

• Activated partial thromboplastin time (aPTT) =< 1.5 x ULN or within therapeutic range if receiving anticoagulant therapy OR

• Creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal

• Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study through 30 days after the last dose of study medication; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately

• Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document (either directly or via a legally authorized representative)

Exclusion Criteria:

• Patients who have had immunotherapy or tyrosine kinase inhibitor (TKI) therapy within two weeks prior to entering the study

• Radiotherapy or prior systemic chemotherapy within 2 weeks

• Patients who have been treated with more than one chemotherapy regimen, immunotherapy regimen or chemotherapy/immunotherapy regimen for metastatic non-small cell lung cancer

• Adverse events resulting from previous therapies have not recovered to grade 1 or less

• Patients may not be receiving any other investigational agents

• Patients with untreated, symptomatic brain metastases should be excluded from this clinical trial (patients with asymptomatic brain metastases amenable to treatment with Gamma Knife radiosurgery ["GKRS"] are eligible and may receive GKRS while on protocol)

• Lactating females

• Patients with EGFR, ALK or ROS-1 mutations who are eligible for treatment with a TKI and who have not received such treatment

• History of allergic reactions attributed to compounds of similar chemical or biologic composition to CPI-613 or docetaxel

• Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

• Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with CPI-613

• Any condition that may, in the opinion of the investigator, compromise the safety of the patient