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

December 17, 2013 updated by: ILEX Oncology Services, Incorporated

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Ottawa Regional Cancer Center - General Division
      • Toronto, Ontario, Canada, M5G 2C4
        • Toronto General Hospital
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Comprehensive Cancer Institute of Huntsville
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Hematology Associates, Ltd.
    • California
      • Greenbrae, California, United States, 94904
        • Marin Cancer Institute
      • La Jolla, California, United States, 92037
        • Scripps Clinic
      • La Jolla, California, United States, 92037
        • Scripps Memorial Hospital Stevens Cancer Center
      • Los Angeles, California, United States, 90033-0800
        • USC/Norris Comprehensive Cancer Center
      • Orange, California, United States, 92613-5600
        • St. Joseph Hospital - Orange
      • Santa Monica, California, United States, 90404
        • John Wayne Cancer Institute
      • Vallejo, California, United States, 94589
        • Kaiser Permanente Medical Center - Vallejo
    • Colorado
      • Denver, Colorado, United States, 80218
        • Rocky Mountain Cancer Center
      • Denver, Colorado, United States, 80262
        • University of Colorado Cancer Center
    • Connecticut
      • Farmington, Connecticut, United States, 06360-7106
        • University of Connecticut Health Center
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Vincent T. Lombardi Cancer Research Center, Georgetown University
    • Florida
      • Atlantis, Florida, United States, 33462
        • Comprehensive Cancer Center at JFK Medical Center
      • Fort Myers, Florida, United States, 33901
        • Radiation Therapy Associates - Fort Myers
      • Miami, Florida, United States, 33176
        • Oncology-Hematology Group of South Florida
      • Tampa, Florida, United States, 33607-6381
        • Bay Area Oncology, MD'S, PA
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush-Presbyterian-St. Luke's Medical Center
      • Chicago, Illinois, United States, 60637
        • University of Chicago Cancer Research Center
    • Indiana
      • Indianapolis, Indiana, United States, 46219
        • Community Hospitals of Indianapolis - Regional Cancer Center
      • South Bend, Indiana, United States, 46601
        • Memorial Hospital of South Bend
    • Kentucky
      • Lexington, Kentucky, United States, 40511-1093
        • Veterans Affairs Medical Center - Lexington
    • Louisiana
      • New Orleans, Louisiana, United States, 70112-2822
        • Louisiana State University School of Medicine
    • Minnesota
      • Coon Rapids, Minnesota, United States, 55433
        • Hubert H. Humphrey Cancer Center
    • Missouri
      • Saint Louis, Missouri, United States, 63110-0250
        • St. Louis University Health Sciences Center
    • Nevada
      • Henderson, Nevada, United States, 89014
        • Southwest Cancer Clinic
    • New Jersey
      • Hamilton, New Jersey, United States, 08690
        • Cancer Institute of New Jersey at Hamilton
    • New York
      • New York, New York, United States, 10003
        • Beth Israel Medical Center
      • New York, New York, United States, 10016
        • Kaplan Cancer Center
      • Rochester, New York, United States, 14642
        • Strong Memorial Hospital of the University of Rochester
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Barrett Cancer Center, The University Hospital
      • Cleveland, Ohio, United States, 44106-5065
        • Ireland Cancer Center
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74136
        • Natalie Warren Bryant Cancer Center
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19001
        • Abington Memorial Hospital
      • Bryn Mawr, Pennsylvania, United States, 19010
        • Hematology-Oncology Mawr Medical North
      • Hershey, Pennsylvania, United States, 17033
        • Milton S. Hershey Medical Center
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Cancer Center
      • Philadelphia, Pennsylvania, United States, 19145
        • Care Group
      • Philadelphia, Pennsylvania, United States, 19146
        • Allegheny University Hospitals - Graduate MCP
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Cancer Institute
      • Pittsburgh, Pennsylvania, United States, 15216
        • Pittsburgh Pediatric Research, Inc.
    • Rhode Island
      • Providence, Rhode Island, United States, 02908-4735
        • Roger Williams Medical Center/BUSM
    • Tennessee
      • Jackson, Tennessee, United States, 38301
        • Jackson Clinic Professional Association
      • Knoxville, Tennessee, United States, 37901
        • Baptist Regional Cancer Center - Knoxville
    • Texas
      • Dallas, Texas, United States, 75246
        • Texas Oncology PA (TOPA) at Baylor-Sammons
      • Galveston, Texas, United States, 77555-1329
        • University of Texas Medical Branch
      • Houston, Texas, United States, 77030
        • University of Texas - MD Anderson Cancer Center
      • Lubbock, Texas, United States, 79410-1894
        • Joe Arrington Cancer Research and Treatment Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ILEX Oncology Services, Incorporated

Investigators

  • Study Chair: Kathleen Heck, MEd, MBA, ILEX Oncology Services, Incorporated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 1996

Study Completion (Actual)

May 1, 2004

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

May 25, 2004

First Posted (Estimate)

May 26, 2004

Study Record Updates

Last Update Posted (Estimate)

December 18, 2013

Last Update Submitted That Met QC Criteria

December 17, 2013

Last Verified

May 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000065284
  • ILEX-C03-IVB/173
  • BB-C03-IVB/173
  • NCI-V96-1113

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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