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Completed

NCT Number: NCT01671332

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

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.

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Key information

Conditions

Carcinoma, Non Small Cell Lung Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Wisconsin Carbone Comprehensive Cancer Center, Madison, Wisconsin, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

docetaxel

Drug

IV over 60 minutes, 75 mg/m2

Other names: Taxotere

suramin

Drug

IV over 30 minutes

Primary outcomes

  1. 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 outcomes

  1. 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

  2. Overall Survival

    Time frame: Up to 50 months

    Compare overall survival of participants in both treatment arms.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • Medical College of Wisconsin
  • Ohio State University
  • Optimum Therapeutics, LLC

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Aug 23, 2012
Registry last updated
May 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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