NCT01671332

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2012

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

June 25, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 23, 2012

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 11, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2016

Completed
3.9 years until next milestone

Results Posted

Study results publicly available

May 12, 2020

Completed
Last Updated

May 12, 2020

Status Verified

May 1, 2020

Enrollment Period

3 years

First QC Date

June 25, 2012

Results QC Date

October 22, 2019

Last Update Submit

May 7, 2020

Conditions

Carcinoma, Non Small Cell Lung

Keywords

Carcinoma, non small cell lungSecond lineThird line

Outcome Measures

Primary Outcomes (1)

  • Progression-free Survival in Months

    Compare progression-free survival (PFS) in participants with advanced NSCLC treated with docetaxel with or without suramin after failure of first-line chemotherapy. PFS is defined as the duration of time from the time of randomization to time of disease progression or death, whichever occurs first.

    Up to 1 year

Secondary Outcomes (4)

  • Response Rate Per RECIST 1.1 Criteria

    Up to 1 year

  • Overall Survival

    Up to 50 months

  • Number of Participants With Toxicity/Adverse Events From Treatment

    Up to 2 years

  • Evaluation of Peripheral Blood Lymphocytes for DNA Damage-induced Checkpoint Control.

    Baseline

Study Arms (2)

Docetaxel

ACTIVE COMPARATOR
Drug: Docetaxel

Docetaxel plus Suramin

EXPERIMENTAL
Drug: SuraminDrug: Docetaxel

Interventions

DocetaxelDRUG

IV over 60 minutes, 75 mg/m2

Also known as: Taxotere
Docetaxel
SuraminDRUG

IV over 30 minutes

Docetaxel plus Suramin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Wisconsin Carbone Comprehensive Cancer Center

Madison, Wisconsin, 53792, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Location

Related Links

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

DocetaxelSuramin

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesNaphthalenesulfonatesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticArylsulfonatesArylsulfonic AcidsSulfonic AcidsSulfur AcidsSulfur CompoundsPolycyclic Compounds

Results Point of Contact

Title
Anne Traynor
Organization
University of Wisconsin
amt@medicine.wisc.edu
608-262-5092

Study Officials

  • Anne M Traynor, MD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

  • Rafael Santana-Davila, MD

    Medical College of Wisconsin

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2012

First Posted

August 23, 2012

Study Start

June 1, 2012

Primary Completion

June 11, 2015

Study Completion

June 16, 2016

Last Updated

May 12, 2020

Results First Posted

May 12, 2020

Record last verified: 2020-05

Locations

US(2)