Marimastat Following Chemotherapy in Treating Patients With Small Cell Lung Cancer

Phase 3

Completed

• Conditions: Lung Cancer
• Interventions: Drug: marimastat; Drug: Placebo

• Registration Number: NCT00003011
• Lead Sponsor: NCIC Clinical Trials Group

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 1997-01-31
• Study First Submitted: 1999-11-01
• Primary Completion: 2001-02-13
• Study First Submitted QC: 2004-02-13
• Study First Posted: 2004-02-16
• Study Completion: 2008-12-15
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-01
• Last Update Posted: 2020-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 555

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Marmistat	marimastat	10 mg PO BID
Placebo	Placebo	10 mg PO BID

Primary Outcome Measures

Name	Time	Method
Overall Survival	4 years	To determine whether treatment with the oral metalloproteinase inhibitor 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 (+I- radiotherapy).

Trial Locations

Locations (38)

Cross Cancer Institute; 🇨🇦 Edmonton, Alberta, Canada

Penticton Regional Hospital; 🇨🇦 Penticton, British Columbia, Canada

British Columbia Cancer Agency; 🇨🇦 Vancouver, British Columbia, Canada

British Columbia Cancer Agency - Vancouver Island Cancer Centre; 🇨🇦 Victoria, British Columbia, Canada

CancerCare Manitoba; 🇨🇦 Winnipeg, Manitoba, Canada

Moncton Hospital; 🇨🇦 Moncton, New Brunswick, Canada

Doctor Leon Richard Oncology Centre; 🇨🇦 Moncton, New Brunswick, Canada

Saint John Regional Hospital; 🇨🇦 Saint John, New Brunswick, Canada

Newfoundland Cancer Treatment and Research Foundation; 🇨🇦 St. Johns, Newfoundland and Labrador, Canada

Nova Scotia Cancer Centre; 🇨🇦 Halifax, Nova Scotia, Canada

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