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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 CenterHouston, Texas  77030-4009
Kaplan Cancer CenterNew York, New York  10016
USC/Norris Comprehensive Cancer CenterLos Angeles, California  90033-0800
University of Colorado Cancer CenterDenver, Colorado  80262
Vincent T. Lombardi Cancer Research Center, Georgetown UniversityWashington, District of Columbia  20007
Rush-Presbyterian-St. Luke's Medical CenterChicago, Illinois  60612
University of Chicago Cancer Research CenterChicago, Illinois  60637
Barrett Cancer Center, The University HospitalCincinnati, Ohio  45219
Ireland Cancer CenterCleveland, Ohio  44106-5065
Abington Memorial HospitalAbington, Pennsylvania  19001
Milton S. Hershey Medical CenterHershey, Pennsylvania  17033
University of Pennsylvania Cancer CenterPhiladelphia, Pennsylvania  19104
University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15213
Baptist Regional Cancer Center - KnoxvilleKnoxville, Tennessee  37901
Radiation Therapy Associates - Fort MyersFort Myers, Florida  33901
Community Hospitals of Indianapolis - Regional Cancer CenterIndianapolis, Indiana  46219
Memorial Hospital of South BendSouth Bend, Indiana  46601
Veterans Affairs Medical Center - LexingtonLexington, Kentucky  40511-1093
St. Louis University Health Sciences CenterSaint Louis, Missouri  63110-0250
Beth Israel Medical CenterNew York, New York  10003
Roger Williams Medical Center/BUSMProvidence, Rhode Island  02908-4735
University of Texas Medical BranchGalveston, Texas  77555-1329
Joe Arrington Cancer Research and Treatment CenterLubbock, Texas  79410-1894
John Wayne Cancer InstituteSanta Monica, California  90404
Scripps ClinicLa Jolla, California  92037
Kaiser Permanente Medical Center - VallejoVallejo, California  94589
Comprehensive Cancer Institute of HuntsvilleHuntsville, Alabama  35801
St. Joseph Hospital - OrangeOrange, California  92868
University of Connecticut Health CenterFarmington, Connecticut  06360-7106
Natalie Warren Bryant Cancer CenterTulsa, Oklahoma  74136
Comprehensive Cancer Center at JFK Medical CenterAtlantis, Florida  33462
Cancer Institute of New Jersey at HamiltonHamilton, New Jersey  08690
Hematology Associates, Ltd.Phoenix, Arizona  85013
Marin Cancer InstituteGreenbrae, California  94904
Scripps Memorial Hospital Stevens Cancer CenterLa Jolla, California  92037
Rocky Mountain Cancer CenterDenver, Colorado  80218
Oncology-Hematology Group of South FloridaMiami, Florida  33176
Bay Area Oncology, MD'S, PATampa, Florida  33607-6381
Louisiana State University School of MedicineNew Orleans, Louisiana  70112-2822
Hubert H. Humphrey Cancer CenterCoon Rapids, Minnesota  55433
Southwest Cancer ClinicHenderson, Nevada  89014
Strong Memorial Hospital of the University of RochesterRochester, New York  14642
Hematology-Oncology Mawr Medical NorthBryn Mawr, Pennsylvania  19010
Care GroupPhiladelphia, Pennsylvania  19145
Allegheny University Hospitals - Graduate MCPPhiladelphia, Pennsylvania  19146
Pittsburgh Pediatric Research, Inc.Pittsburgh, Pennsylvania  15216
Jackson Clinic Professional AssociationJackson, Tennessee  38301
Texas Oncology PA (TOPA) at Baylor-SammonsDallas, Texas  75246