Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Related Publications
Trial Contact Information
Registry Information

Alternate Title

Marimastat Following Chemotherapy in Treating Patients With Small Cell Lung Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Completed	16 and over		EORTC-08962 CAN-NCIC-BR12, EORTC-08962B, NCT00003011, BR12

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. 

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

Expected Enrollment

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.

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.

Shepherd FA, Giaccone G, Seymour L, et al.: Prospective, randomized, double-blind, placebo-controlled trial of marimastat after response to first-line chemotherapy in patients with small-cell lung cancer: a trial of the National Cancer Institute of Canada-Clinical Trials Group and the European Organization for Research and Treatment of Cancer. J Clin Oncol 20 (22): 4434-9, 2002.[PUBMED Abstract]

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 the American Society of Clinical Oncology 20: A-11, 4a, 2001.

Huisman C, Postmus PE, Giaccone G, et al.: Second-line chemotherapy and its evaluation in small cell lung cancer. Cancer Treat Rev 25 (4): 199-206, 1999.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Giuseppe Giaccone, MD, PhD, Protocol chair(Contact information may not be current)		Ph: 31-20-444-4321 Email: g.giaccone@vumc.nl

NCIC-Clinical Trials Group

Frances A. Shepherd, MD, Protocol chair		Ph: 416-946-4522

Registry Information
Official Title		A Phase III Study of Marimastat in Patients with Small Cell Lung Cancer Following a Response to First Line Chemotherapy
Trial Start Date		1997-03-01
Registered in ClinicalTrials.gov		NCT00003011
Date Submitted to PDQ		1997-03-01
Information Last Verified		2007-05-14

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