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A PHASE III, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF MARIMASTAT IN PATIENTS WITH MINIMAL DISEASE STAGE III NON-SMALL CELL LUNG CANCER


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

Thank you

Trial Information

A PHASE III, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF MARIMASTAT IN PATIENTS WITH MINIMAL DISEASE STAGE III NON-SMALL CELL LUNG CANCER


OBJECTIVES: I. Compare the effect of marimastat (a matrix metalloproteinase inhibitor) vs.
placebo on overall survival in patients with Stage III non-small cell lung cancer who have
minimal residual disease following chemotherapy, radiotherapy, and/or surgery. II. Assess
the effect of marimastat on time to disease progression in these patients. III. Assess the
safety and tolerability of marimastat in these patients.

OUTLINE: This is a randomized, double-blind study. Patients are randomized no less than 2
and no more than 8 weeks after the last prior treatment modality received. Patients are
stratified by participating institution. Patients are randomly assigned to receive either
oral marimastat or oral placebo twice daily. Treatment begins within 5 days of minimization
and continues for up to 18 months after the last patient is enrolled, unless disease
progression or unacceptable toxicity intervenes. Patients deriving benefit at end of study
may continue treatment if desired. Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 504 patients will be entered over 30 months from approximately
60 centers.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung
cancer Stage IIIA/B disease No malignant pleural effusions Minimal residual disease after
one or a combination of the following: Incomplete surgical resection i.e., macroscopic
residual disease at completion of surgery Radical radiotherapy with no evidence of disease
progression at entry Documented complete or partial tumor response following at least 2
courses of cytotoxic chemotherapy No evidence of disease progression during or following
prior therapy

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Hematopoietic:
Absolute neutrophil count greater than 500/mm3 Platelet count greater than 50,000/mm3
Hepatic: Bilirubin less than 2.0 times upper limit of normal (ULN) AST/ALT no greater than
3.0 times ULN Renal: Creatinine no greater than 1.5 times ULN Other: No acute illness
within 1 week of start of study No other illness that would significantly interfere with
study outcome No major medical illness that precludes prolonged marimastat administration
No second malignancy within 5 years except: Adequately treated basal cell carcinoma of the
skin In situ carcinoma of the cervix Not pregnant or nursing Medically approved method of
contraception required of fertile women Willing and able to tolerate and comply with study
requirements

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease
Characteristics No prior marimastat, batimastat, bleomycin, or busulphan No more than 1
cytotoxic chemotherapy regimen for non-small cell lung cancer Endocrine therapy: Not
specified Radiotherapy: See Disease Characteristics Surgery: See Disease Characteristics
Other: At least 4 weeks since any investigational drug therapies

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Kathleen Heck, MEd, MBA

Investigator Role:

Study Chair

Investigator Affiliation:

ILEX Oncology Services, Incorporated

Authority:

United States: Federal Government

Study ID:

CDR0000065284

NCT ID:

NCT00002911

Start Date:

December 1996

Completion Date:

Related Keywords:

  • Lung Cancer
  • stage IIIA non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009
Kaplan Cancer Center New York, New York  10016
USC/Norris Comprehensive Cancer Center Los Angeles, California  90033-0800
University of Colorado Cancer Center Denver, Colorado  80262
Vincent T. Lombardi Cancer Research Center, Georgetown University Washington, District of Columbia  20007
Rush-Presbyterian-St. Luke's Medical Center Chicago, Illinois  60612
University of Chicago Cancer Research Center Chicago, Illinois  60637
Barrett Cancer Center, The University Hospital Cincinnati, Ohio  45219
Ireland Cancer Center Cleveland, Ohio  44106-5065
Abington Memorial Hospital Abington, Pennsylvania  19001
Milton S. Hershey Medical Center Hershey, Pennsylvania  17033
University of Pennsylvania Cancer Center Philadelphia, Pennsylvania  19104
University of Pittsburgh Cancer Institute Pittsburgh, Pennsylvania  15213
Baptist Regional Cancer Center - Knoxville Knoxville, Tennessee  37901
Radiation Therapy Associates - Fort Myers Fort Myers, Florida  33901
Community Hospitals of Indianapolis - Regional Cancer Center Indianapolis, Indiana  46219
Memorial Hospital of South Bend South Bend, Indiana  46601
Veterans Affairs Medical Center - Lexington Lexington, Kentucky  40511-1093
St. Louis University Health Sciences Center Saint Louis, Missouri  63110-0250
Beth Israel Medical Center New York, New York  10003
Roger Williams Medical Center/BUSM Providence, Rhode Island  02908-4735
University of Texas Medical Branch Galveston, Texas  77555-1329
Joe Arrington Cancer Research and Treatment Center Lubbock, Texas  79410-1894
John Wayne Cancer Institute Santa Monica, California  90404
Scripps Clinic La Jolla, California  92037
Kaiser Permanente Medical Center - Vallejo Vallejo, California  94589
Comprehensive Cancer Institute of Huntsville Huntsville, Alabama  35801
St. Joseph Hospital - Orange Orange, California  92868
University of Connecticut Health Center Farmington, Connecticut  06360-7106
Natalie Warren Bryant Cancer Center Tulsa, Oklahoma  74136
Comprehensive Cancer Center at JFK Medical Center Atlantis, Florida  33462
Cancer Institute of New Jersey at Hamilton Hamilton, New Jersey  08690
Hematology Associates, Ltd. Phoenix, Arizona  85013
Marin Cancer Institute Greenbrae, California  94904
Scripps Memorial Hospital Stevens Cancer Center La Jolla, California  92037
Rocky Mountain Cancer Center Denver, Colorado  80218
Oncology-Hematology Group of South Florida Miami, Florida  33176
Bay Area Oncology, MD'S, PA Tampa, Florida  33607-6381
Louisiana State University School of Medicine New Orleans, Louisiana  70112-2822
Hubert H. Humphrey Cancer Center Coon Rapids, Minnesota  55433
Southwest Cancer Clinic Henderson, Nevada  89014
Strong Memorial Hospital of the University of Rochester Rochester, New York  14642
Hematology-Oncology Mawr Medical North Bryn Mawr, Pennsylvania  19010
Care Group Philadelphia, Pennsylvania  19145
Allegheny University Hospitals - Graduate MCP Philadelphia, Pennsylvania  19146
Pittsburgh Pediatric Research, Inc. Pittsburgh, Pennsylvania  15216
Jackson Clinic Professional Association Jackson, Tennessee  38301
Texas Oncology PA (TOPA) at Baylor-Sammons Dallas, Texas  75246