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Marimastat Following Chemotherapy in Treating Patients With Small Cell Lung Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Marimastat Following Chemotherapy in Treating Patients With Small Cell Lung Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Marimastat Following Chemotherapy in Treating Patients With Small Cell Lung Cancer Clinical research trials and Marimastat Following Chemotherapy in Treating Patients With Small Cell Lung Cancer healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Marimastat Following Chemotherapy in Treating Patients With Small Cell Lung Cancer. Marimastat Following Chemotherapy in Treating Patients With Small Cell Lung Cancer Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Marimastat Following Chemotherapy in Treating Patients With Small Cell Lung Cancer clinical trial. Human subjects often receive the most effective healthcare possible for their Marimastat Following Chemotherapy in Treating Patients With Small Cell Lung Cancer condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "M" Clinical Trials Conditions > Marimastat Following Chemotherapy in Treating Patients With Small Cell Lung Cancer  Marimastat Following Chemotherapy in Treating Patients With Small Cell Lung Cancer
Marimastat Following Chemotherapy in Treating Patients With Small Cell Lung Cancer
For Condition: Recurrent Small Cell Lung Cancer
Status: Completed
Sponsor(s): EORTC Lung Cancer Cooperative Group , National Cancer Institute of Canada
Synopsis: 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.
Details: 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. PROTOCOL 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 16 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically or cytologically proven small cell lung cancer - Complete response (CR) or partial response (PR) following first line chemotherapy required; Chest x-ray showing CR or PR required. - No documented prior brain metastases --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: One prior induction combination chemotherapy regimen required; Must be completed prior to randomization; Hematologically recovered before randomization; Minimum of 4 cycles required; No change in regimen due to progression; No chemotherapy within 28 days prior to randomization if thoracic radiation is given prior to or concurrent with chemotherapy; No prior marimastat - Endocrine therapy: Not specified - Radiotherapy: Prior radiotherapy allowed; Must be completed prior to randomization; Last dose of radiation treatment must be within 7-14 days prior to randomization if thoracic radiation and/or prophylactic cranial irradiation is given after completion of chemotherapy; If severe esophagitis precludes administration of oral medication, randomization may be within 21 days after radiation therapy - Surgery: No surgery within 2 weeks prior to randomization; Prior complete resection of tumor allowed - Other: No other investigational agents within 4 weeks prior to study, and none planned; No concurrent coumarin anticoagulants and no coumarin anticoagulants within 4 weeks prior to randomization; No concurrent antitumor treatment --Patient Characteristics-- - Age: 16 and over - Performance status: ECOG 0-2 - Life expectancy: At least 12 weeks - Hematopoietic: Not specified - Hepatic: Not specified - Renal: Not specified - Other: Not pregnant or nursing; Effective contraception use by men or women of reproductive potential; No prior malignancies within 5 years except: Adequately treated nonmelanomatous skin cancer; Adequately treated carcinoma in situ of the cervix; No other concurrent malignancies; No prior diagnosis of breast cancer, melanoma, or hypernephroma; No major medical illness that would preclude prolonged administration of marimastat or required follow up; No active peptic ulceration or symptoms suggestive of this diagnosis; No grade 3 or 4 musculoskeletal disorders
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ChristianManegold, Study Chair, EORTC Lung Cancer Cooperative Group
Doctor Leon Richard Oncology Centre
Moncton, New Brunswick, E1C 8X3
Canada
Northwestern Ontario Regional Cancer Centre, Thunder Bay
Thunder Bay, Ontario, P7A 7T1
Canada
Mount Sinai Hospital - Toronto
Toronto, Ontario, M5G 1X5
Canada
Hamilton Regional Cancer Centre
Hamilton, Ontario, L8V 5C2
Canada
Ottawa Regional Cancer Centre - General Campus
Ottawa, Ontario, K1H 1C4
Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4
Canada
Cancer Care Ontario - Windsor Regional Cancer Centre
Windsor, Ontario, N8W 2X3
Canada
Humber River Regional Hospital
Weston, Ontario, M9N 1N8
Canada
William Osler Health Centre
Brampton, Ontario, L6W 2Z8
Canada
Credit Valley Hospital
Mississauga, Ontario, L5M 2N1
Canada
Lakeridge Health Oshawa
Oshawa, Ontario, L1G 2B9
Canada
Hopital Du Sacre-Coeur de Montreal
Montreal, Quebec, H4J 1C5
Canada
Peterborough Oncology Clinic
Peterborough, Ontario, K9H 7B6
Canada
Toronto East General Hospital
Toronto, Ontario, M4C 3E7
Canada
Toronto General Hospital
Toronto, Ontario, M5G 2C4
Canada
Northeastern Ontario Regional Cancer Centre, Sudbury
Sudbury, Ontario, P3E 5J1
Canada
Trillium Health Centre
Mississauga, Ontario, L5B 1B8
Canada
Moncton Hospital
Moncton, New Brunswick, E1C 6ZB
Canada
British Columbia Cancer Agency - Vancouver Island Cancer Centre
Victoria, British Columbia, V8R 6V5
Canada
Hotel Dieu Health Sciences Hospital - Niagara
St. Catharines, Ontario, L2R 5K3
Canada
CHUS-Hopital Fleurimont
Fleurimont, Quebec, J1H 5N4
Canada
Saint Joseph's Health Centre - Toronto
Toronto, Ontario, M6R 1B5
Canada
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9
Canada
Nova Scotia Cancer Centre
Halifax, Nova Scotia, B3H 1V7
Canada
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, M4N 3M5
Canada
Saint John Regional Hospital
Saint John, New Brunswick, E2L 4L2
Canada
Newfoundland Cancer Treatment and Research Foundation
St. Johns, Newfoundland and Labrador, A1B 3V6
Canada
Hopital du Saint-Sacrament, Quebec
Quebec City, Quebec, G1S 4L8
Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1
Canada
British Columbia Cancer Agency
Vancouver, British Columbia, V5Z 4E6
Canada
St. Michael's Hospital - Toronto
Toronto, Ontario, M5B 1W8
Canada
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2L-4M1
Canada
North York General Hospital, Ontario
North York, Ontario, M2E 1K1
Canada
L'Hopital Laval
Ste Foy, Quebec, G1V 4G5
Canada
McGill University
Montreal, Quebec, H2W 1S6
Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Canada
Penticton Regional Hospital
Penticton, British Columbia, V2A 3G6
Canada
York County Hospital
Newmarket, Ontario, L3Y 2P9
Canada
Additional Information:
Study ID Numbers: CDR0000065589; EORTC-08962,EORTC-08962B
Study Start Date: March 1997
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003011
Other Recurrent Small Cell Lung Cancer Studies:
1. Chloroquinoxaline Sulfonamide in Treating Patients With Small Cell Lung Cancer
2. Fenretinide in Treating Patients With Recurrent Small Cell Lung Cancer
3. Combination Chemotherapy and Imatinib Mesylate in Treating Patients With Extensive-Stage Small Cell Lung Cancer
4. Interleukin-2 Combined With Monoclonal Antibody Therapy in Treating Patients With Kidney, Bladder, or Lung Cancer That Has Not Responded to Previous Treatment
5. Topotecan and Paclitaxel in Treating Patients With Recurrent or Refractory Small Cell Lung Cancer
Related Studies:
Other Recurrent Small Cell Lung Cancer Clinical Trials
Other Ontario Clinical Trials
Other Toronto Clinical Trials
Marimastat Following Chemotherapy in Treating Patients With Small Cell Lung Cancer
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