Docetaxel +/- Suramin in 2nd Line Advanced Non-Small Cell Lung Cancer
Status: | Active, not recruiting |
---|---|
Conditions: | Lung Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 10/14/2017 |
Start Date: | June 2012 |
End Date: | December 2016 |
Randomized Phase II Study of Suramin and Docetaxel Versus Docetaxel in Non-Small Cell Lung Cancer After Failure of First-Line Chemotherapy
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.
standard treatment with docetaxel improves progression-free survival for patients with
advanced non-small cell lung cancer in the second and third line settings.
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
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
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
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Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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