NCT00072618

Brief Summary

The purpose of this study is to determine if the combination of Taxotere and exisulind is an effective and safe treatment for patients with advanced NSCLC who have failed a prior platinum-containing regimen.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2001

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

October 1, 2001

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2003

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 5, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 7, 2003

Completed
Last Updated

October 20, 2011

Status Verified

October 1, 2011

First QC Date

November 5, 2003

Last Update Submit

October 18, 2011

Conditions

NSCLC

Interventions

ExisulindDRUG

Eligibility Criteria

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

You may qualify if:

  • Histologically documented advanced cancer or advanced platinum-refractory non-small cell lung cancer. Platinum refractory defined as progressive disease during a platinum regimen or within 6 months following treatment.
  • Negative serum pregnancy test, if fertile female. Have not taken sulindac (Clinoril®) on regular basis for any indication for one week prior to enrollment and willing to remain off of sulindac for the duration of the study.
  • \> 18 years or of legal age. Male patients, or non-pregnant and non-lactating female patients either using adequate birth control (oral contraceptives or Provera), surgically sterile or post-menopausal.
  • Willingness to remain off chronic NSAIDs (with the exception of ibuprofen, naproxen, or aspirin) for duration of the study. Low dose aspirin for cardiovascular prevention is acceptable.
  • No treatment with any other chemotherapy or radiotherapy within 2 weeks prior to entering the study.

You may not qualify if:

  • Any condition or any medication which may interfere with the conduct of the study.
  • Known hypersensitivity to sulindac (Clinoril®) or taxanes. Use of an investigational medication or device within one month of initiating study therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Colorado Health Sciences Center

Aurora, Colorado, 80045, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Interventions

sulindac sulfone

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2003

First Posted

November 7, 2003

Study Start

October 1, 2001

Study Completion

August 1, 2003

Last Updated

October 20, 2011

Record last verified: 2011-10

Locations

US(2)