Clinical trial NCT01671332: Docetaxel +/- Suramin in 2nd Line Advanced Non-Small Cell Lung Cancer
Official title: Randomized Phase II Study of Suramin and Docetaxel Versus Docetaxel in Non-Small Cell Lung Cancer After Failure of First-Line Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Non Small Cell Lung
Keywords: Carcinoma, non small cell lung
Second line
Third line
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Medical College of Wisconsin
name: Optimum Therapeutics, LLC
name: Ohio State University
First posted: 2012-08-23
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Progression-free Survival in Months
timeFrame: Up to 1 year
Secondary outcomes:
measure: Response Rate Per RECIST 1.1 Criteria
timeFrame: Up to 1 year
measure: Overall Survival
timeFrame: Up to 50 months
measure: Number of Participants With Toxicity/Adverse Events From Treatment
timeFrame: Up to 2 years
measure: Evaluation of Peripheral Blood Lymphocytes for DNA Damage-induced Checkpoint Control.
timeFrame: Baseline
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Carbone Comprehensive Cancer Center
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Anne M Traynor, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical College of Wisconsin
name: Rafael Santana-Davila, MD
role: STUDY_CHAIR
References: