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A Phase I/II Multi-Center Study of Weekly Taxotere (Docetaxel) in Combination With Aptosyn (Exisulind) in Non-Small Cell Lung Cancer (NSCLC) Patients Who Have Failed a Prior Platinum-Containing Regimen


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
NSCLC

Thank you

Trial Information

A Phase I/II Multi-Center Study of Weekly Taxotere (Docetaxel) in Combination With Aptosyn (Exisulind) in Non-Small Cell Lung Cancer (NSCLC) Patients Who Have Failed a Prior Platinum-Containing Regimen


Inclusion Criteria:



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.

Exclusion Criteria:

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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

026B

NCT ID:

NCT00072618

Start Date:

October 2001

Completion Date:

August 2003

Related Keywords:

  • NSCLC
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

University of Colorado Health Sciences CenterDenver, Colorado  80262
University of Chicago Medical CenterChicago, Illinois  60637