Prinomastat and Combination Chemotherapy in Treating Patients With Metastatic or Recurrent Non-small Cell Lung Cancer

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00004199

Enrollment

Unknown

Registered

2004-07-19

Start date

1999-03-31

Completion date

Unknown

Last updated

2012-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

recurrent non-small cell lung cancer, stage IV non-small cell lung cancer

Brief summary

RATIONALE: Prinomastat may stop the growth of non-small cell lung cancer by stopping blood flow to the tumor. Drugs used in chemotherapy stop tumor cells from dividing so they stop growing or die. PURPOSE: Randomized phase III trial to determine the effectiveness of prinomastat plus cisplatin and gemcitabine in treating patients who have metastatic or recurrent non-small cell lung cancer.

Detailed description

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.

Interventions

DRUGcisplatin

DRUGgemcitabine hydrochloride

DRUGprinomastat

Study design

Allocation

RANDOMIZED

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026