Spots Global Cancer Trial Database for Marimastat Following Chemotherapy in Treating Patients With Small Cell Lung Cancer
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Trial Identification
Brief Title: Marimastat Following Chemotherapy in Treating Patients With Small Cell Lung Cancer
Official Title: A Phase III Study of Marimastat in Patients With Small Cell Lung Cancer Following a Response to First Line Chemotherapy
Study ID: NCT00003011
Conditions
Study Description
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.
Keywords
Eligibility
Minimum Age: 16 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
William Osler Health Centre, Brampton, Ontario, Canada
Hamilton Regional Cancer Centre, Hamilton, Ontario, Canada
Trillium Health Centre, Mississauga, Ontario, Canada
Credit Valley Hospital, Mississauga, Ontario, Canada
York County Hospital, Newmarket, Ontario, Canada
North York General Hospital, Ontario, North York, Ontario, Canada
Lakeridge Health Oshawa, Oshawa, Ontario, Canada
Ottawa Regional Cancer Centre - General Campus, Ottawa, Ontario, Canada
Peterborough Oncology Clinic, Peterborough, Ontario, Canada
Hotel Dieu Health Sciences Hospital - Niagara, St. Catharines, Ontario, Canada
Northeastern Ontario Regional Cancer Centre, Sudbury, Sudbury, Ontario, Canada
Northwestern Ontario Regional Cancer Centre, Thunder Bay, Thunder Bay, Ontario, Canada
Toronto East General Hospital, Toronto, Ontario, Canada
Toronto Sunnybrook Regional Cancer Centre, Toronto, Ontario, Canada
St. Michael's Hospital - Toronto, Toronto, Ontario, Canada
Mount Sinai Hospital - Toronto, Toronto, Ontario, Canada
Toronto General Hospital, Toronto, Ontario, Canada
Saint Joseph's Health Centre - Toronto, Toronto, Ontario, Canada
Humber River Regional Hospital, Weston, Ontario, Canada
Cancer Care Ontario - Windsor Regional Cancer Centre, Windsor, Ontario, Canada
CHUS-Hopital Fleurimont, Fleurimont, Quebec, Canada
Centre Hospitalier de l'Universite de Montreal, Montreal, Quebec, Canada
McGill University, Montreal, Quebec, Canada
Hopital Du Sacre-Coeur de Montreal, Montreal, Quebec, Canada
Hopital du Saint-Sacrament, Quebec, Quebec City, Quebec, Canada
L'Hopital Laval, Ste-Foy, Quebec, Canada
Allan Blair Cancer Centre, Regina, Saskatchewan, Canada
Saskatoon Cancer Centre, Saskatoon, Saskatchewan, Canada
Contact Details
Name: Giuseppe Giaccone, MD, PhD
Affiliation: Free University Medical Center
Role: STUDY_CHAIR
Name: Frances A. Shepherd, MD
Affiliation: Princess Margaret Hospital, Canada
Role: STUDY_CHAIR
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