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

This study is currently recruiting participants.

Verified May 2013 by University of Wisconsin, Madison

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: May 22, 2013

Last verified: May 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

June 25, 2012

Last Updated Date

May 22, 2013

Start Date ^ICMJE

June 2012

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01671332 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Carcinoma, Non Small Cell Lung

Intervention ^ICMJE

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

Study Arm (s)

Active Comparator: Docetaxel
Intervention: Drug: Docetaxel
Experimental: Docetaxel plus Suramin
Interventions:
- Drug: Suramin
- Drug: Docetaxel

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2015

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01671332

Other Study ID Numbers ^ICMJE

CO11508

Has Data Monitoring Committee

Yes

Responsible Party

University of Wisconsin, Madison

Study Sponsor ^ICMJE

University of Wisconsin, Madison

Collaborators ^ICMJE

Medical College of Wisconsin
Optimum Therapeutics, LLC
Ohio State University

Investigators ^ICMJE

Principal Investigator:	Anne M Traynor, MD	University of Wisconsin, Madison
Study Chair:	Rafael Santana-Davila, MD	Medical College of Wisconsin

Information Provided By

University of Wisconsin, Madison

Verification Date

May 2013

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

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