Lung Cancer Clinical Trial
Official title:
A Phase III Study of Marimastat in Patients With Small Cell Lung Cancer Following a Response to First Line Chemotherapy
RATIONALE: Marimastat may stop the growth of lung cancer by stopping blood flow to the tumor.
It is not yet known if marimastat is an effective treatment for small cell lung cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of marimastat with a placebo
following chemotherapy in treating patients who have small cell lung cancer.
OBJECTIVES: I. Determine whether treatment with the oral matrix metalloproteinase inhibitor
(MMPI) marimastat prolongs overall survival and time to progression in patients with small
cell lung cancer who have achieved complete or partial remission after first line
chemotherapy, with or without radiotherapy. II. Determine the tolerability and toxicity of
prolonged administration of marimastat in patients with small cell lung cancer. III.
Determine the effect of prolonged administration of marimastat on the quality of life of
patients with small cell lung cancer.
OUTLINE: This is a randomized, double blind, multicenter, placebo controlled study. Patients
are stratified by stage of disease at diagnosis, response to prior chemotherapy/radiotherapy,
type of thoracic radiotherapy, and cooperative group. Patients are randomized into two
groups. Half of the patients take marimastat orally twice a day (breakfast and evening meal);
the other half take placebo orally twice a day (breakfast and evening meal). Treatment
continues for 2 years or until documented disease recurrence or progression and institution
of further anticancer treatment, occurrence of unacceptable toxicity, initiation of
anticoagulant treatment, or development of intercurrent illness. All patients are followed
every 6 months until death.
PROJECTED ACCRUAL: The planned sample size is 360, with an equal number of patients in both
arms, accrued at a rate of 240 responders per year (resulting in an accrual period of
approximately 1.5 years). The total duration of the study is estimated as 2.3 years.
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