Marimastat Following Chemotherapy in Treating Patients With Small Cell Lung Cancer

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003011
• Other study ID #: BR12
• Secondary ID: EORTC-08962CAN-N
• Status: Completed
• Phase: Phase 3
• Start date: January 31, 1997
• Est. completion date: December 15, 2008

Study information

• Verified date: April 2020
• Source: Canadian Cancer Trials Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 555
• Est. completion date: December 15, 2008
• Est. primary completion date: February 13, 2001
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Small Cell Lung Carcinoma

Intervention

Drug:
• marimastat
10 mg PO BID
• Placebo
10 mg PO BID

Locations

Country	Name	City	State
Canada	William Osler Health Centre	Brampton	Ontario
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	CHUS-Hopital Fleurimont	Fleurimont	Quebec
Canada	Nova Scotia Cancer Centre	Halifax	Nova Scotia
Canada	Hamilton Regional Cancer Centre	Hamilton	Ontario
Canada	Credit Valley Hospital	Mississauga	Ontario
Canada	Trillium Health Centre	Mississauga	Ontario
Canada	Doctor Leon Richard Oncology Centre	Moncton	New Brunswick
Canada	Moncton Hospital	Moncton	New Brunswick
Canada	Centre Hospitalier de l'Universite de Montreal	Montreal	Quebec
Canada	Hopital Du Sacre-Coeur de Montreal	Montreal	Quebec
Canada	McGill University	Montreal	Quebec
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	Penticton Regional Hospital	Penticton	British Columbia
Canada	Peterborough Oncology Clinic	Peterborough	Ontario
Canada	Hopital du Saint-Sacrament, Quebec	Quebec City	Quebec
Canada	Allan Blair Cancer Centre	Regina	Saskatchewan
Canada	Saint John Regional Hospital	Saint John	New Brunswick
Canada	Saskatoon Cancer Centre	Saskatoon	Saskatchewan
Canada	Hotel Dieu Health Sciences Hospital - Niagara	St. Catharines	Ontario
Canada	Newfoundland Cancer Treatment and Research Foundation	St. Johns	Newfoundland and Labrador
Canada	L'Hopital Laval	Ste-Foy	Quebec
Canada	Northeastern Ontario Regional Cancer Centre, Sudbury	Sudbury	Ontario
Canada	Northwestern Ontario Regional Cancer Centre, Thunder Bay	Thunder Bay	Ontario
Canada	Mount Sinai Hospital - Toronto	Toronto	Ontario
Canada	Saint Joseph's Health Centre - Toronto	Toronto	Ontario
Canada	St. Michael's Hospital - Toronto	Toronto	Ontario
Canada	Toronto East General Hospital	Toronto	Ontario
Canada	Toronto General Hospital	Toronto	Ontario
Canada	Toronto Sunnybrook Regional Cancer Centre	Toronto	Ontario
Canada	British Columbia Cancer Agency	Vancouver	British Columbia
Canada	British Columbia Cancer Agency - Vancouver Island Cancer Centre	Victoria	British Columbia
Canada	Humber River Regional Hospital	Weston	Ontario
Canada	Cancer Care Ontario - Windsor Regional Cancer Centre	Windsor	Ontario
Canada	CancerCare Manitoba	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
NCIC Clinical Trials Group

Country where clinical trial is conducted

Canada, 

References & Publications (3)

Huisman C, Postmus PE, Giaccone G, Smit EF. Second-line chemotherapy and its evaluation in small cell lung cancer. Cancer Treat Rev. 1999 Aug;25(4):199-206. Review. — View Citation

Shepherd FA, Giaccone G, Debruyne C, et al.: Randomizd double-blind placebo-controlled trial of marimastat in patients with small cell lung cancer (SCLC) following response to first-line chemotherapy: an NCIC-CTG and EORTC study. [Abstract] Proceedings of

Shepherd FA, Giaccone G, Seymour L, Debruyne C, Bezjak A, Hirsh V, Smylie M, Rubin S, Martins H, Lamont A, Krzakowski M, Sadura A, Zee B. Prospective, randomized, double-blind, placebo-controlled trial of marimastat after response to first-line chemothera — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival	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).	4 years