Marimastat Following Chemotherapy in Treating Patients With Small Cell Lung Cancer
Lung Cancer
About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring recurrent small cell lung cancer
Eligibility 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 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 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
Sites / Locations
- Cross Cancer Institute
- Penticton Regional Hospital
- British Columbia Cancer Agency
- British Columbia Cancer Agency - Vancouver Island Cancer Centre
- CancerCare Manitoba
- Moncton Hospital
- Doctor Leon Richard Oncology Centre
- Saint John Regional Hospital
- Newfoundland Cancer Treatment and Research Foundation
- Nova Scotia Cancer Centre
- William Osler Health Centre
- Hamilton Regional Cancer Centre
- Trillium Health Centre
- Credit Valley Hospital
- York County Hospital
- North York General Hospital, Ontario
- Lakeridge Health Oshawa
- Ottawa Regional Cancer Centre - General Campus
- Peterborough Oncology Clinic
- Hotel Dieu Health Sciences Hospital - Niagara
- Northeastern Ontario Regional Cancer Centre, Sudbury
- Northwestern Ontario Regional Cancer Centre, Thunder Bay
- Toronto East General Hospital
- Toronto Sunnybrook Regional Cancer Centre
- St. Michael's Hospital - Toronto
- Mount Sinai Hospital - Toronto
- Toronto General Hospital
- Saint Joseph's Health Centre - Toronto
- Humber River Regional Hospital
- Cancer Care Ontario - Windsor Regional Cancer Centre
- CHUS-Hopital Fleurimont
- Centre Hospitalier de l'Universite de Montreal
- McGill University
- Hopital Du Sacre-Coeur de Montreal
- Hopital du Saint-Sacrament, Quebec
- L'Hopital Laval
- Allan Blair Cancer Centre
- Saskatoon Cancer Centre
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Marmistat
Placebo
10 mg PO BID
10 mg PO BID