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A Phase III Study of Marimastat in Patients With Small Cell Lung Cancer Following a Response to First Line Chemotherapy


Phase 3
16 Years
N/A
Not Enrolling
Both
Lung Cancer

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Trial Information

A Phase III Study of Marimastat in Patients With Small Cell Lung Cancer Following a Response to First Line Chemotherapy


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Overall Survival

Outcome Description:

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).

Outcome Time Frame:

4 years

Safety Issue:

No

Principal Investigator

Giuseppe Giaccone, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Free University Medical Center

Authority:

Canada: Health Canada

Study ID:

BR12

NCT ID:

NCT00003011

Start Date:

March 1997

Completion Date:

December 2008

Related Keywords:

  • Lung Cancer
  • recurrent small cell lung cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

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