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

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:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Docetaxel

U.S. FDA Resources

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:	December 2013 (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

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

Locations

United States, Wisconsin
University of Wisconsin Carbone Comprehensive Cancer Center	Recruiting
Madison, Wisconsin, United States, 53792
Contact: Hilary Hernan, MPH 608-262-8158 hrhernan@medicine.wisc.edu
Principal Investigator: Anne Traynor, MD
Sub-Investigator: Toby Campbell, MD
Sub-Investigator: Tien Hoang, MD

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:	February 13, 2013
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

ClinicalTrials.gov processed this record on May 16, 2013