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A Randomized, Double-Blind, Placebo-Controlled, Phase III Study of the Matrix Metalloprotease Inhibitor Prinomastat (AG3340) in Combination With Gemcitabine and Cisplatin in Patients Having Advanced Non-Small Cell Lung Cancer


Phase 3
18 Years
N/A
Not Enrolling
Both
Lung Cancer

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Trial Information

A Randomized, Double-Blind, Placebo-Controlled, Phase III Study of the Matrix Metalloprotease Inhibitor Prinomastat (AG3340) in Combination With Gemcitabine and Cisplatin in Patients Having Advanced Non-Small Cell Lung Cancer


OBJECTIVES: I. Compare the overall survival, progression free survival, symptomatic
progression free survival, and one year survival of patients with metastatic or recurrent
non-small cell lung cancer treated with prinomastat (AG3340) or placebo in combination with
gemcitabine and cisplatin. II. Compare the disease response and duration of response in
these patients on these regimens. III. Compare the quality of life of these patients on
these regimens. IV. Evaluate the safety of these regimens in these patients.

OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients
receive oral prinomastat or placebo twice daily beginning on day 1, followed by gemcitabine
IV on days 1 and 8 and cisplatin IV on day 1. Courses repeat every 3 weeks.

PROJECTED ACCRUAL: Approximately 420 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Stage IV or recurrent or T4 lesion non-small cell lung cancer
Measurable or evaluable disease No brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-1 Life expectancy: Not
specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy for non-small cell lung cancer Endocrine therapy: Not specified Radiotherapy:
Not specified Surgery: Not specified

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Mary Collier

Investigator Role:

Study Chair

Investigator Affiliation:

Agouron Pharmaceuticals

Authority:

United States: Federal Government

Study ID:

AG-3340-017

NCT ID:

NCT00004199

Start Date:

March 1999

Completion Date:

Related Keywords:

  • Lung Cancer
  • recurrent non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Agouron Pharmaceuticals, Inc.La Jolla, California  92037