Docetaxel +/- Suramin in 2nd Line Advanced Non-Small Cell Lung Cancer

University of Wisconsin, Madison80 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Carcinoma, Non Small Cell Lung

Interventions

DocetaxelDRUG

IV over 60 minutes, 75 mg/m2

SuraminDRUG

IV over 30 minutes

DocetaxelDRUG

IV over 60 minutes. 56 mg/m2

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

University of Wisconsin Carbone Comprehensive Cancer Center

Madison, Wisconsin, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Outcomes

Primary Outcomes

Progression-free Survival in Months

Compare progression-free survival (PFS) in participants with advanced NSCLC treated with docetaxel with or without suramin after failure of first-line chemotherapy. PFS is defined as the duration of time from the time of randomization to time of disease progression or death, whichever occurs first.

Time frame: Up to 1 year

Secondary Outcomes

Response Rate Per RECIST 1.1 Criteria

Response rate per RECIST 1.1, as follows: Complete response (CR): Disappearance of all extranodal target lesions. All pathological lymph nodes must have decreased to \<10 mm in short axis Partial response (PR): At least 30% decrease in the sum of longest diameters (SLD) of target lesions, taking as reference the baseline sum diameters Progressive disease (PD): SLD increased by at least 20% from the smallest value on study (including baseline, if that is smallest). The SLD must also demonstrate an absolute increase of at least 5 mm. (Two lesions increasing from 2mm to 3mm, for example, does not qualify). Stable disease (SD): Neither sufficient shrinkage to qualify for PR not sufficient increase to qualify for PD

Time frame: Up to 1 year

Overall Survival

Compare overall survival of participants in both treatment arms.

Time frame: Up to 50 months

Number of Participants With Toxicity/Adverse Events From Treatment

The investigators will compare the toxicity profiles of the two arms of therapy to determine if the docetaxel + suramin has a more favorable toxicity profile than docetaxel alone. This count includes only adverse events considered definitely, probably, or possibly due to treatment.

Time frame: Up to 2 years

Evaluation of Peripheral Blood Lymphocytes for DNA Damage-induced Checkpoint Control.

The investigators hypothesize that suramin in combination with docetaxel improves response rates and survival by increasing the cancer cell population in the M phase of the cell cycle. The G2-M checkpoint control score, defined as (%M-phase arrested cells after cisplatin+suramin)/(%M-phase arrested cells after cisplatin), is an indicator of the effect of suramin on cell accumulation in the M-phase. G2-M checkpoint control was evaluated as a predictor of PFS and OS in participant receiving suramin by linear correlation.

Data from ClinicalTrials.gov

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