Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Docetaxel

+ Suramin

+ Docetaxel

Drug
Who is being recruted

Bronchial Neoplasms+7

+ Carcinoma, Bronchogenic

+ Lung Diseases

Over 18 Years
+15 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: June 2012
See protocol details

Summary

Principal SponsorUniversity of Wisconsin, Madison
Last updated: May 12, 2020
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2012

Actual date on which the first participant was enrolled.

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

NCT01671332
Principal SponsorUniversity of Wisconsin, Madison
Last updated: May 12, 2020
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

80 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bronchial NeoplasmsCarcinoma, BronchogenicLung DiseasesLung NeoplasmsNeoplasmsNeoplasms by SiteRespiratory Tract DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsCarcinoma, Non-Small-Cell Lung

Criteria

10 inclusion criteria required to participate
Adequate bone marrow function
Adequate liver function
Adequate renal function
Documented disease progression after first-line chemotherapy for non-small cell lung cancer
Show More Criteria
5 exclusion criteria prevent from participating
Pre-existing grade 3 or 4 neuropathy
Receipt of 3 or more prior chemotherapy regimens
Severe hypersensitivity reaction to docetaxel
Uncontrolled intercurrent illness
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator

Group II

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

University of Wisconsin Carbone Comprehensive Cancer Center

Madison, United StatesOpen University of Wisconsin Carbone Comprehensive Cancer Center in Google Maps

Medical College of Wisconsin

Milwaukee, United States
Completed2 Study Centers