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
  Purpose

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.


Condition Intervention Phase
Carcinoma, Non Small Cell Lung
Drug: Docetaxel
Drug: Suramin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Phase II Study of Suramin and Docetaxel Versus Docetaxel in Non-Small Cell Lung Cancer After Failure of First-Line Chemotherapy

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 80
Study Start Date: June 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Docetaxel Drug: Docetaxel
IV over 60 minutes, 75 mg/m2
Other Name: Taxotere
Experimental: Docetaxel plus Suramin Drug: Suramin
IV over 30 minutes
Drug: Docetaxel
IV over 60 minutes. 56 mg/m2
Other Name: Taxotere

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01671332

Locations
United States, Wisconsin
University of Wisconsin Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Sponsors and Collaborators
University of Wisconsin, Madison
Medical College of Wisconsin
Optimum Therapeutics, LLC
Ohio State University
Investigators
Principal Investigator: Anne M Traynor, MD University of Wisconsin, Madison
Study Chair: Rafael Santana-Davila, MD Medical College of Wisconsin
  More Information

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01671332     History of Changes
Other Study ID Numbers: CO11508
Study First Received: June 25, 2012
Last Updated: April 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Wisconsin, Madison:
Carcinoma, non small cell lung
Second line
Third line

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Suramin
Docetaxel
Antinematodal Agents
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents
Trypanocidal Agents
Antiprotozoal Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014