Overview

This trial is active, not recruiting.

Condition carcinoma, non small cell lung
Treatments docetaxel, suramin
Phase phase 2
Sponsor University of Wisconsin, Madison
Collaborator Medical College of Wisconsin
Start date June 2012
End date June 2015
Trial size 80 participants
Trial identifier NCT01671332, CO11508

Summary

The overall purpose of the study is to determine whether or not the inclusion of suramin to standard treatment with docetaxel improves progression-free survival for patients with advanced non-small cell lung cancer in the second and third line settings.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
docetaxel Taxotere
IV over 60 minutes, 75 mg/m2
(Experimental)
suramin
IV over 30 minutes
docetaxel Taxotere
IV over 60 minutes. 56 mg/m2

Primary Outcomes

Measure
Progression-free survival in months
time frame: From the time of randomization to the time of progression of disease, evaluated every 6 weeks, for up to 52 weeks.

Secondary Outcomes

Measure
Response rate per RECIST 1.1 criteria
time frame: From baseline to the time of response, evaluated every 6 weeks, for up to 52 weeks.
Overall survival
time frame: From the time of registration to the time of death, assessed once each month for up to 50 months
Toxicity/Adverse Events from treatment
time frame: Day 1 of each cycle of treatment, and 30 days post end of treatment
Evaluation of peripheral blood lymphocytes for DNA damage-induced checkpoint control.
time frame: Baseline

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Pathologically proven diagnosis of non-small cell lung cancer - Documented disease progression after first-line chemotherapy for non-small cell lung cancer - Stable and treated CNS metastasis is allowed - Radiation must be completed at least 2 weeks prior to starting protocol treatment - Major surgery must be completed at least 4 weeks prior to starting protocol treatment - ECOG performance status 0-2 - Sexually active patients must use adequate contraception - Adequate bone marrow function - Adequate renal function - Adequate liver function Exclusion Criteria: - Severe hypersensitivity reaction to docetaxel - Pre-existing grade 3 or 4 neuropathy - Women who are pregnant or breastfeeding - Uncontrolled intercurrent illness - Receipt of 3 or more prior chemotherapy regimens

Additional Information

Official title Randomized Phase II Study of Suramin and Docetaxel Versus Docetaxel in Non-Small Cell Lung Cancer After Failure of First-Line Chemotherapy
Principal investigator Anne M Traynor, MD
Description The overall purpose of the study is to determine whether or not the inclusion of suramin to standard treatment with docetaxel improves progression-free survival for patients with advanced non-small cell lung cancer in the second and third line settings. Secondary objectives include: - To compare response rate of patients in both treatment arms - To compare overall survival of patients in both treatment arms - To compare toxicity in both treatment arms - To determine whether the survival benefit from suramin is associated with reduced M-phase entry in peripheral blood lymphocytes
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of Wisconsin, Madison.