Docetaxel +/- Suramin in 2nd Line Advanced Non-Small Cell Lung Cancer
This trial is active, not recruiting.
|Condition||carcinoma, non small cell lung|
|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|
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|
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
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.
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.
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
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
|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|
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