Randomized Phase II Study of Suramin and Docetaxel Versus Docetaxel in Non-Small Cell Lung Cancer After Failure of First-Line Chemotherapy
18 Years
N/A
Both
Carcinoma, Non Small Cell Lung
Trial Information
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression-free survival in months
Outcome Time Frame:
From the time of randomization to the time of progression of disease, evaluated every 6 weeks, for up to 52 weeks.
Safety Issue:
No
Principal Investigator
Anne M Traynor, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Wisconsin, Madison
Authority:
United States: Food and Drug Administration
Study ID:
CO11508
NCT ID:
NCT01671332
Start Date:
June 2012
Completion Date:
December 2015
Related Keywords:
- Carcinoma, Non Small Cell Lung
- Carcinoma, non small cell lung
- Second line
- Third line
- Carcinoma
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
| University of Wisconsin Carbone Comprehensive Cancer Center | Madison, Wisconsin 53792 |
