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NCT00072618 Clinical Trial

Phase II Study of Taxotere in Combination With Exisulind in Non-Small Cell Lung Cancer (NSCLC) Patients

NSCLC Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00072618
Other study ID # 026B
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received November 5, 2003
Last updated October 18, 2011
Start date October 2001
Est. completion date August 2003

Study information
Verified date October 2011
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Other known NCT identifiers
  • NCT00036010

Recruitment information / eligibility
Status Completed
Enrollment 52
Est. completion date August 2003
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• Exisulind

Locations
Country Name City State
United States University of Colorado Health Sciences Center Aurora Colorado
United States University of Chicago Medical Center Chicago Illinois

Sponsors (2)
Lead Sponsor Collaborator
Astellas Pharma Inc OSI Pharmaceuticals

Country where clinical trial is conducted

United States, 

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