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

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.

Full Title of Study: “Randomized Phase II Study of Suramin and Docetaxel Versus Docetaxel in Non-Small Cell Lung Cancer After Failure of First-Line Chemotherapy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 11, 2015

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

Interventions

  • Drug: Docetaxel
    • IV over 60 minutes, 75 mg/m2
  • Drug: Suramin
    • IV over 30 minutes
  • Drug: Docetaxel
    • IV over 60 minutes. 56 mg/m2

Arms, Groups and Cohorts

  • Active Comparator: Docetaxel
  • Experimental: Docetaxel plus Suramin

Clinical Trial Outcome Measures

Primary Measures

  • Progression-free Survival in Months
    • Time Frame: Up to 1 year
    • 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.

Secondary Measures

  • Response Rate Per RECIST 1.1 Criteria
    • Time Frame: Up to 1 year
    • 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
  • Overall Survival
    • Time Frame: Up to 50 months
    • Compare overall survival of participants in both treatment arms.
  • Number of Participants With Toxicity/Adverse Events From Treatment
    • Time Frame: Up to 2 years
    • 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.
  • Evaluation of Peripheral Blood Lymphocytes for DNA Damage-induced Checkpoint Control.
    • Time Frame: Baseline
    • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Wisconsin, Madison
  • Collaborator
    • Medical College of Wisconsin
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Anne M Traynor, MD, Principal Investigator, University of Wisconsin, Madison
    • Rafael Santana-Davila, MD, Study Chair, Medical College of Wisconsin

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