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

NCT00002911 | Completed Phase 3

• 4 other identifiers: CDR0000065284ILEX-C03-IVB/173BB-C03-IVB/173NCI-V96-1113
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 50

Brief 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.

Conditions

Lung Cancer

Keywords

stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer

Interventions

marimastat DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• ILEX Oncology Services, Incorporated: lead

Study Sites (50)

Comprehensive Cancer Institute of Huntsville

Huntsville, Alabama, 35801, United States

Location

Hematology Associates, Ltd.

Phoenix, Arizona, 85013, United States

Location

Marin Cancer Institute

Greenbrae, California, 94904, United States

Location

Scripps Clinic

La Jolla, California, 92037, United States

Location

Scripps Memorial Hospital Stevens Cancer Center

La Jolla, California, 92037, United States

Location

USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90033-0800, United States

Location

St. Joseph Hospital - Orange

Orange, California, 92613-5600, United States

Location

John Wayne Cancer Institute

Santa Monica, California, 90404, United States

Location

Kaiser Permanente Medical Center - Vallejo

Vallejo, California, 94589, United States

Location

Rocky Mountain Cancer Center

Denver, Colorado, 80218, United States

Location

University of Colorado Cancer Center

Denver, Colorado, 80262, United States

Location

University of Connecticut Health Center

Farmington, Connecticut, 06360-7106, United States

Location

Vincent T. Lombardi Cancer Research Center, Georgetown University

Washington D.C., District of Columbia, 20007, United States

Location

Comprehensive Cancer Center at JFK Medical Center

Atlantis, Florida, 33462, United States

Location

Radiation Therapy Associates - Fort Myers

Fort Myers, Florida, 33901, United States

Location

Oncology-Hematology Group of South Florida

Miami, Florida, 33176, United States

Location

Bay Area Oncology, MD'S, PA

Tampa, Florida, 33607-6381, United States

Location

Rush-Presbyterian-St. Luke's Medical Center

Chicago, Illinois, 60612, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637, United States

Location

Community Hospitals of Indianapolis - Regional Cancer Center

Indianapolis, Indiana, 46219, United States

Location

Memorial Hospital of South Bend

South Bend, Indiana, 46601, United States

Location

Veterans Affairs Medical Center - Lexington

Lexington, Kentucky, 40511-1093, United States

Location

Louisiana State University School of Medicine

New Orleans, Louisiana, 70112-2822, United States

Location

Hubert H. Humphrey Cancer Center

Coon Rapids, Minnesota, 55433, United States

Location

St. Louis University Health Sciences Center

St Louis, Missouri, 63110-0250, United States

Location

Southwest Cancer Clinic

Henderson, Nevada, 89014, United States

Location

Cancer Institute of New Jersey at Hamilton

Hamilton, New Jersey, 08690, United States

Location

Beth Israel Medical Center

New York, New York, 10003, United States

Location

Kaplan Cancer Center

New York, New York, 10016, United States

Location

Strong Memorial Hospital of the University of Rochester

Rochester, New York, 14642, United States

Location

Barrett Cancer Center, The University Hospital

Cincinnati, Ohio, 45219, United States

Location

Ireland Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

Natalie Warren Bryant Cancer Center

Tulsa, Oklahoma, 74136, United States

Location

Abington Memorial Hospital

Abington, Pennsylvania, 19001, United States

Location

Hematology-Oncology Mawr Medical North

Bryn Mawr, Pennsylvania, 19010, United States

Location

Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

University of Pennsylvania Cancer Center

Philadelphia, Pennsylvania, 19104, United States

Location

Care Group

Philadelphia, Pennsylvania, 19145, United States

Location

Allegheny University Hospitals - Graduate MCP

Philadelphia, Pennsylvania, 19146, United States

Location

University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15213, United States

Location

Pittsburgh Pediatric Research, Inc.

Pittsburgh, Pennsylvania, 15216, United States

Location

Roger Williams Medical Center/BUSM

Providence, Rhode Island, 02908-4735, United States

Location

Jackson Clinic Professional Association

Jackson, Tennessee, 38301, United States

Location

Baptist Regional Cancer Center - Knoxville

Knoxville, Tennessee, 37901, United States

Location

Texas Oncology PA (TOPA) at Baylor-Sammons

Dallas, Texas, 75246, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555-1329, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Joe Arrington Cancer Research and Treatment Center

Lubbock, Texas, 79410-1894, United States

Location

Ottawa Regional Cancer Center - General Division

Ottawa, Ontario, K1H 8L6, Canada

Location

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

marimastat

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Study Officials

• Kathleen Heck, MEd, MBA

  ILEX Oncology Services, Incorporated

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: May 26, 2004
• Study Start: December 1, 1996
• Study Completion: May 1, 2004
• Last Updated: December 18, 2013

Record last verified: 2007-05

Locations

CA (2); US (48)