Marimastat in Treating Patients With Stage III Non-small Cell Lung Cancer

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002911
• Other study ID #: CDR0000065284
• Secondary ID: ILEX-C03-IVB/173
• Status: Completed
• Phase: Phase 3
• First received: November 1, 1999
• Last updated: December 17, 2013
• Start date: December 1996
• Est. completion date: May 2004

Study information

• Verified date: May 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Marimastat may stop the growth of non-small cell lung cancer by stopping blood flow to the tumor.

PURPOSE: Randomized double-blinded phase III trial to determine the effectiveness of marimastat in treating patients who have residual stage III non-small cell lung cancer.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: May 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• marimastat

Locations

Country	Name	City	State
Canada	Ottawa Regional Cancer Center - General Division	Ottawa	Ontario
Canada	Toronto General Hospital	Toronto	Ontario
United States	Abington Memorial Hospital	Abington	Pennsylvania
United States	Comprehensive Cancer Center at JFK Medical Center	Atlantis	Florida
United States	Hematology-Oncology Mawr Medical North	Bryn Mawr	Pennsylvania
United States	Rush-Presbyterian-St. Luke's Medical Center	Chicago	Illinois
United States	University of Chicago Cancer Research Center	Chicago	Illinois
United States	Barrett Cancer Center, The University Hospital	Cincinnati	Ohio
United States	Ireland Cancer Center	Cleveland	Ohio
United States	Hubert H. Humphrey Cancer Center	Coon Rapids	Minnesota
United States	Texas Oncology PA (TOPA) at Baylor-Sammons	Dallas	Texas
United States	Rocky Mountain Cancer Center	Denver	Colorado
United States	University of Colorado Cancer Center	Denver	Colorado
United States	University of Connecticut Health Center	Farmington	Connecticut
United States	Radiation Therapy Associates - Fort Myers	Fort Myers	Florida
United States	University of Texas Medical Branch	Galveston	Texas
United States	Marin Cancer Institute	Greenbrae	California
United States	Cancer Institute of New Jersey at Hamilton	Hamilton	New Jersey
United States	Southwest Cancer Clinic	Henderson	Nevada
United States	Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	University of Texas - MD Anderson Cancer Center	Houston	Texas
United States	Comprehensive Cancer Institute of Huntsville	Huntsville	Alabama
United States	Community Hospitals of Indianapolis - Regional Cancer Center	Indianapolis	Indiana
United States	Jackson Clinic Professional Association	Jackson	Tennessee
United States	Baptist Regional Cancer Center - Knoxville	Knoxville	Tennessee
United States	Scripps Clinic	La Jolla	California
United States	Scripps Memorial Hospital Stevens Cancer Center	La Jolla	California
United States	Veterans Affairs Medical Center - Lexington	Lexington	Kentucky
United States	USC/Norris Comprehensive Cancer Center	Los Angeles	California
United States	Joe Arrington Cancer Research and Treatment Center	Lubbock	Texas
United States	Oncology-Hematology Group of South Florida	Miami	Florida
United States	Louisiana State University School of Medicine	New Orleans	Louisiana
United States	Beth Israel Medical Center	New York	New York
United States	Kaplan Cancer Center	New York	New York
United States	St. Joseph Hospital - Orange	Orange	California
United States	Allegheny University Hospitals - Graduate MCP	Philadelphia	Pennsylvania
United States	Care Group	Philadelphia	Pennsylvania
United States	University of Pennsylvania Cancer Center	Philadelphia	Pennsylvania
United States	Hematology Associates, Ltd.	Phoenix	Arizona
United States	Pittsburgh Pediatric Research, Inc.	Pittsburgh	Pennsylvania
United States	University of Pittsburgh Cancer Institute	Pittsburgh	Pennsylvania
United States	Roger Williams Medical Center/BUSM	Providence	Rhode Island
United States	Strong Memorial Hospital of the University of Rochester	Rochester	New York
United States	St. Louis University Health Sciences Center	Saint Louis	Missouri
United States	John Wayne Cancer Institute	Santa Monica	California
United States	Memorial Hospital of South Bend	South Bend	Indiana
United States	Bay Area Oncology, MD'S, PA	Tampa	Florida
United States	Natalie Warren Bryant Cancer Center	Tulsa	Oklahoma
United States	Kaiser Permanente Medical Center - Vallejo	Vallejo	California
United States	Vincent T. Lombardi Cancer Research Center, Georgetown University	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
ILEX Oncology Services, Incorporated

Countries where clinical trial is conducted

United States,  Canada,