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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Medical College of Wisconsin
Optimum Therapeutics, LLC
Ohio State University
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01671332
First received: June 25, 2012
Last updated: April 17, 2014
Last verified: April 2014

June 25, 2012
April 17, 2014
June 2012
January 2015   (final data collection date for primary outcome measure)
Progression-free survival in months [ Time Frame: From the time of randomization to the time of progression of disease, evaluated every 6 weeks, for up to 52 weeks. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01671332 on ClinicalTrials.gov Archive Site
  • Response rate per RECIST 1.1 criteria [ Time Frame: From baseline to the time of response, evaluated every 6 weeks, for up to 52 weeks. ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: From the time of registration to the time of death, assessed once each month for up to 50 months ] [ Designated as safety issue: No ]
  • Toxicity/Adverse Events from treatment [ Time Frame: Day 1 of each cycle of treatment, and 30 days post end of treatment ] [ Designated as safety issue: Yes ]
    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.
  • Evaluation of peripheral blood lymphocytes for DNA damage-induced checkpoint control. [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    The investigators hypothesize that suramin in combination with docetaxel improves response rates and survival by preventing the cancer cells to enter M phase of the cell cycle.
Same as current
Not Provided
Not Provided
 
Docetaxel +/- Suramin in 2nd Line Advanced Non-Small Cell Lung Cancer
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.

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
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Carcinoma, Non Small Cell Lung
  • Drug: Docetaxel
    IV over 60 minutes, 75 mg/m2
    Other Name: Taxotere
  • Drug: Suramin
    IV over 30 minutes
  • Drug: Docetaxel
    IV over 60 minutes. 56 mg/m2
    Other Name: Taxotere
  • Active Comparator: Docetaxel
    Intervention: Drug: Docetaxel
  • Experimental: Docetaxel plus Suramin
    Interventions:
    • Drug: Suramin
    • Drug: Docetaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
80
December 2015
January 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01671332
CO11508
Yes
University of Wisconsin, Madison
University of Wisconsin, Madison
  • Medical College of Wisconsin
  • Optimum Therapeutics, LLC
  • Ohio State University
Principal Investigator: Anne M Traynor, MD University of Wisconsin, Madison
Study Chair: Rafael Santana-Davila, MD Medical College of Wisconsin
University of Wisconsin, Madison
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP