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

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
marimastat
Sponsored by
ILEX Oncology Services, Incorporated
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Comprehensive Cancer Institute of Huntsville
  • Hematology Associates, Ltd.
  • Marin Cancer Institute
  • Scripps Clinic
  • Scripps Memorial Hospital Stevens Cancer Center
  • USC/Norris Comprehensive Cancer Center
  • St. Joseph Hospital - Orange
  • John Wayne Cancer Institute
  • Kaiser Permanente Medical Center - Vallejo
  • Rocky Mountain Cancer Center
  • University of Colorado Cancer Center
  • University of Connecticut Health Center
  • Vincent T. Lombardi Cancer Research Center, Georgetown University
  • Comprehensive Cancer Center at JFK Medical Center
  • Radiation Therapy Associates - Fort Myers
  • Oncology-Hematology Group of South Florida
  • Bay Area Oncology, MD'S, PA
  • Rush-Presbyterian-St. Luke's Medical Center
  • University of Chicago Cancer Research Center
  • Community Hospitals of Indianapolis - Regional Cancer Center
  • Memorial Hospital of South Bend
  • Veterans Affairs Medical Center - Lexington
  • Louisiana State University School of Medicine
  • Hubert H. Humphrey Cancer Center
  • St. Louis University Health Sciences Center
  • Southwest Cancer Clinic
  • Cancer Institute of New Jersey at Hamilton
  • Beth Israel Medical Center
  • Kaplan Cancer Center
  • Strong Memorial Hospital of the University of Rochester
  • Barrett Cancer Center, The University Hospital
  • Ireland Cancer Center
  • Natalie Warren Bryant Cancer Center
  • Abington Memorial Hospital
  • Hematology-Oncology Mawr Medical North
  • Milton S. Hershey Medical Center
  • University of Pennsylvania Cancer Center
  • Care Group
  • Allegheny University Hospitals - Graduate MCP
  • University of Pittsburgh Cancer Institute
  • Pittsburgh Pediatric Research, Inc.
  • Roger Williams Medical Center/BUSM
  • Jackson Clinic Professional Association
  • Baptist Regional Cancer Center - Knoxville
  • Texas Oncology PA (TOPA) at Baylor-Sammons
  • University of Texas Medical Branch
  • University of Texas - MD Anderson Cancer Center
  • Joe Arrington Cancer Research and Treatment Center
  • Ottawa Regional Cancer Center - General Division
  • Toronto General Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
December 17, 2013
Sponsor
ILEX Oncology Services, Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT00002911
Brief Title
Marimastat in Treating Patients With Stage III Non-small Cell Lung Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2007
Overall Recruitment Status
Completed
Study Start Date
December 1996 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
ILEX Oncology Services, Incorporated

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
marimastat

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen Heck, MEd, MBA
Organizational Affiliation
ILEX Oncology Services, Incorporated
Official's Role
Study Chair
Facility Information:
Facility Name
Comprehensive Cancer Institute of Huntsville
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Hematology Associates, Ltd.
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Marin Cancer Institute
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
Scripps Clinic
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Scripps Memorial Hospital Stevens Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
USC/Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033-0800
Country
United States
Facility Name
St. Joseph Hospital - Orange
City
Orange
State/Province
California
ZIP/Postal Code
92613-5600
Country
United States
Facility Name
John Wayne Cancer Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Kaiser Permanente Medical Center - Vallejo
City
Vallejo
State/Province
California
ZIP/Postal Code
94589
Country
United States
Facility Name
Rocky Mountain Cancer Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
University of Colorado Cancer Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
University of Connecticut Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06360-7106
Country
United States
Facility Name
Vincent T. Lombardi Cancer Research Center, Georgetown University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Comprehensive Cancer Center at JFK Medical Center
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Facility Name
Radiation Therapy Associates - Fort Myers
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Oncology-Hematology Group of South Florida
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Bay Area Oncology, MD'S, PA
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607-6381
Country
United States
Facility Name
Rush-Presbyterian-St. Luke's Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Chicago Cancer Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Community Hospitals of Indianapolis - Regional Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46219
Country
United States
Facility Name
Memorial Hospital of South Bend
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Veterans Affairs Medical Center - Lexington
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40511-1093
Country
United States
Facility Name
Louisiana State University School of Medicine
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112-2822
Country
United States
Facility Name
Hubert H. Humphrey Cancer Center
City
Coon Rapids
State/Province
Minnesota
ZIP/Postal Code
55433
Country
United States
Facility Name
St. Louis University Health Sciences Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110-0250
Country
United States
Facility Name
Southwest Cancer Clinic
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89014
Country
United States
Facility Name
Cancer Institute of New Jersey at Hamilton
City
Hamilton
State/Province
New Jersey
ZIP/Postal Code
08690
Country
United States
Facility Name
Beth Israel Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Kaplan Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Strong Memorial Hospital of the University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Barrett Cancer Center, The University Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Ireland Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5065
Country
United States
Facility Name
Natalie Warren Bryant Cancer Center
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Abington Memorial Hospital
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Facility Name
Hematology-Oncology Mawr Medical North
City
Bryn Mawr
State/Province
Pennsylvania
ZIP/Postal Code
19010
Country
United States
Facility Name
Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
University of Pennsylvania Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Care Group
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19145
Country
United States
Facility Name
Allegheny University Hospitals - Graduate MCP
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19146
Country
United States
Facility Name
University of Pittsburgh Cancer Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Pittsburgh Pediatric Research, Inc.
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15216
Country
United States
Facility Name
Roger Williams Medical Center/BUSM
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02908-4735
Country
United States
Facility Name
Jackson Clinic Professional Association
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38301
Country
United States
Facility Name
Baptist Regional Cancer Center - Knoxville
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37901
Country
United States
Facility Name
Texas Oncology PA (TOPA) at Baylor-Sammons
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555-1329
Country
United States
Facility Name
University of Texas - MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Joe Arrington Cancer Research and Treatment Center
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410-1894
Country
United States
Facility Name
Ottawa Regional Cancer Center - General Division
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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