Lung CancerPhase 3NCT00002911
Marimastat in Treating Patients With Stage III Non-small Cell Lung Cancer
A Phase 3 study testing marimastat in people with Lung Cancer, run by ILEX Oncology Services, Incorporated at 50 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- marimastat
- How many people
- Not given
- Where
- 50 sitesin 2 countries
- Study dates
- Dec 1996to May 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
50 sites in 2 countries.
50 sites in 2 countries
United States48 sites
Abington Memorial Hospital
Abington, Pennsylvania, 19001
Comprehensive Cancer Center at JFK Medical Center
Atlantis, Florida, 33462
Hematology-Oncology Mawr Medical North
Bryn Mawr, Pennsylvania, 19010
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, 60612
University of Chicago Cancer Research Center
Chicago, Illinois, 60637
Barrett Cancer Center, The University Hospital
Cincinnati, Ohio, 45219
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
Hubert H. Humphrey Cancer Center
Coon Rapids, Minnesota, 55433
Texas Oncology PA (TOPA) at Baylor-Sammons
Dallas, Texas, 75246
Rocky Mountain Cancer Center
Denver, Colorado, 80218
University of Colorado Cancer Center
Denver, Colorado, 80262
University of Connecticut Health Center
Farmington, Connecticut, 06360-7106
Radiation Therapy Associates - Fort Myers
Fort Myers, Florida, 33901
University of Texas Medical Branch
Galveston, Texas, 77555-1329
Marin Cancer Institute
Greenbrae, California, 94904
Cancer Institute of New Jersey at Hamilton
Hamilton, New Jersey, 08690
Southwest Cancer Clinic
Henderson, Nevada, 89014
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030
Comprehensive Cancer Institute of Huntsville
Huntsville, Alabama, 35801
Community Hospitals of Indianapolis - Regional Cancer Center
Indianapolis, Indiana, 46219
Jackson Clinic Professional Association
Jackson, Tennessee, 38301
Baptist Regional Cancer Center - Knoxville
Knoxville, Tennessee, 37901
Scripps Clinic
La Jolla, California, 92037
Scripps Memorial Hospital Stevens Cancer Center
La Jolla, California, 92037
Veterans Affairs Medical Center - Lexington
Lexington, Kentucky, 40511-1093
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033-0800
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, 79410-1894
Oncology-Hematology Group of South Florida
Miami, Florida, 33176
Louisiana State University School of Medicine
New Orleans, Louisiana, 70112-2822
Beth Israel Medical Center
New York, New York, 10003
Kaplan Cancer Center
New York, New York, 10016
St. Joseph Hospital - Orange
Orange, California, 92613-5600
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104
Care Group
Philadelphia, Pennsylvania, 19145
Allegheny University Hospitals - Graduate MCP
Philadelphia, Pennsylvania, 19146
Hematology Associates, Ltd.
Phoenix, Arizona, 85013
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15213
Pittsburgh Pediatric Research, Inc.
Pittsburgh, Pennsylvania, 15216
Roger Williams Medical Center/BUSM
Providence, Rhode Island, 02908-4735
Strong Memorial Hospital of the University of Rochester
Rochester, New York, 14642
John Wayne Cancer Institute
Santa Monica, California, 90404
Memorial Hospital of South Bend
South Bend, Indiana, 46601
St. Louis University Health Sciences Center
St Louis, Missouri, 63110-0250
Bay Area Oncology, MD'S, PA
Tampa, Florida, 33607-6381
Natalie Warren Bryant Cancer Center
Tulsa, Oklahoma, 74136
Kaiser Permanente Medical Center - Vallejo
Vallejo, California, 94589
Vincent T. Lombardi Cancer Research Center, Georgetown University
Washington D.C., District of Columbia, 20007
Canada2 sites
Ottawa Regional Cancer Center - General Division
Ottawa, Ontario, K1H 8L6
Toronto General Hospital
Toronto, Ontario, M5G 2C4
About this study
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
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.
Read the 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.
- Conditions
- Lung Cancer
- Being tested
- marimastat
- Keywords
- stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
marimastatDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2004 (estimated)
- Study startDec 1996
- Study completionMay 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
Sponsor and investigators
- Lead sponsor
- ILEX Oncology Services, Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Kathleen Heck, MEd, MBA, Study chair, ILEX Oncology Services, Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002911
- Sponsor's protocol ID
- CDR0000065284
- Other IDs
- ILEX-C03-IVB/173, BB-C03-IVB/173, NCI-V96-1113
- Status last verified
- May 2007
- First submitted
- 1 Nov 1999
- Last updated
- 18 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00002911
- Acronym / sponsor ID
- CDR0000065284
- Conditions
- Lung Cancer
- Keywords
- stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- ILEX Oncology Services, IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Dec 1996
- Study completion
- May 2004 (actual)
- First posted
- 26 May 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| marimastat | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen Heck, MEd, MBA study chair
ILEX Oncology Services, Incorporated
50 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing marimastat in people with Lung Cancer, run by ILEX Oncology Services, Incorporated at 50 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2013.