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Marimastat in Treating Patients With Stage III Non-small Cell Lung Cancer Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Marimastat in Treating Patients With Stage III Non-small Cell Lung Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Marimastat in Treating Patients With Stage III Non-small Cell Lung Cancer Clinical research trials and Marimastat in Treating Patients With Stage III Non-small Cell Lung Cancer healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Marimastat in Treating Patients With Stage III Non-small Cell Lung Cancer. Marimastat in Treating Patients With Stage III Non-small Cell Lung Cancer Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Marimastat in Treating Patients With Stage III Non-small Cell Lung Cancer clinical trial. Participants typically obtain the most effective healthcare available for their Marimastat in Treating Patients With Stage III Non-small Cell Lung Cancer condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "M" Clinical Trials Conditions > Marimastat in Treating Patients With Stage III Non-small Cell Lung Cancer  Marimastat in Treating Patients With Stage III Non-small Cell Lung Cancer
Marimastat in Treating Patients With Stage III Non-small Cell Lung Cancer
For Condition: stage 3A non-small cell lung cancer,stage 3B non-small cell lung cancer
Status: Completed
Sponsor(s): ILEX Oncology ,
Synopsis: 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.
Details: 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. PROTOCOL 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
KathleenHeck, Study Chair, ILEX Oncology
University of Chicago Cancer Research Center
Chicago, Illinois, 60637
United States
Texas Oncology PA (TOPA) at Baylor-Sammons
Dallas, Texas, 75246
United States
Hematology Associates, Ltd.
Phoenix, Arizona, 85013
United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15213
United States
University of Texas Medical Branch
Galveston, Texas, 77555-1329
United States
Barrett Cancer Center, The University Hospital
Cincinnati, Ohio, 45219
United States
Hubert H. Humphrey Cancer Center
Coon Rapids, Minnesota, 55433
United States
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
United States
Jackson Clinic Professional Association
Jackson, Tennessee, 38301
United States
Roger Williams Medical Center/BUSM
Providence, Rhode Island, 02908-4735
United States
Oncology-Hematology Group of South Florida
Miami, Florida, 33176
United States
Scripps Clinic
La Jolla, California, 92037
United States
Pittsburgh Pediatric Research, Inc.
Pittsburgh, Pennsylvania, 15216
United States
Hematology-Oncology Mawr Medical North
Bryn Mawr, Pennsylvania, 19010
United States
Community Hospitals of Indianapolis - Regional Cancer Center
Indianapolis, Indiana, 46219
United States
Comprehensive Cancer Center at JFK Medical Center
Atlantis, Florida, 33462
United States
Ottawa Regional Cancer Center - General Division
Ottawa, Ontario, K1H 8L6
Canada
Cancer Institute of New Jersey at Hamilton
Hamilton, New Jersey, 08690
United States
Comprehensive Cancer Institute of Huntsville
Huntsville, Alabama, 35801
United States
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
United States
Kaplan Cancer Center
New York City, New York, 10016
United States
Radiation Therapy Associates - Fort Myers
Ft. Myers, Florida, 33901
United States
Beth Israel Medical Center
New York City, New York, 10003
United States
Memorial Hospital of South Bend
South Bend, Indiana, 46601
United States
Vincent T. Lombardi Cancer Research Center, Georgetown University
Washington D.C., District of Columbia, 20007
United States
Scripps Memorial Hospital Stevens Cancer Center
La Jolla, California, 92037
United States
Toronto General Hospital
Toronto, Ontario, M5G 2C4
Canada
Veterans Affairs Medical Center - Lexington
Lexington, Kentucky, 40511-1093
United States
Marin Cancer Institute
Greenbrae, California, 94904
United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104
United States
Allegheny University Hospitals - Graduate MCP
Philadelphia, Pennsylvania, 19146
United States
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, 60612
United States
Rocky Mountain Cancer Center
Denver, Colorado, 80218
United States
Kaiser Permanente Medical Center - Vallejo
Vallejo, California, 94589
United States
Natalie Warren Bryant Cancer Center
Tulsa, Oklahoma, 74136
United States
Louisiana State University School of Medicine
New Orleans, Louisiana, 70112-2822
United States
St. Louis University Health Sciences Center
St. Louis, Missouri, 63110-0250
United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001
United States
Care Group
Philadelphia, Pennsylvania, 19145
United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033-0800
United States
Bay Area Oncology, MD'S, PA
Tampa, Florida, 33607-6381
United States
Southwest Cancer Clinic
Henderson, Nevada, 89014
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030
United States
University of Connecticut Health Center
Farmington, Connecticut, 06360-7106
United States
University of Colorado Cancer Center
Denver, Colorado, 80262
United States
John Wayne Cancer Institute
Santa Monica, California, 90404
United States
Strong Memorial Hospital of the University of Rochester
Rochester, New York, 14642
United States
St. Joseph Hospital - Orange
Orange, California, 92613-5600
United States
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, 79410-1894
United States
Baptist Regional Cancer Center - Knoxville
Knoxville, Tennessee, 37901
United States
Additional Information:
Study ID Numbers: CDR0000065284; ILEX-C03-IVB/173,NCI-V96-1113,BB-C03-IVB/173
Study Start Date: December 1996
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002911
Other Stage 3a Non-Small Cell Lung Cancer Studies:
1. Vaccine Therapy, Interleukin-2, and Sargramostim in Treating Patients With Advanced Tumors
2. Positron Emission Tomography for Detecting Non-small Cell Lung Cancer
3. Surgery With or Without Preoperative Chemotherapy in Treating Patients With Resectable Non-small Cell Lung Cancer
4. High-Dose 3-Dimensional Conformal Radiation Therapy in Treating Patients With Inoperable Stage I, Stage II, or Stage IIIA Non-Small Cell Lung Cancer
5. Prognostic Study of Metastases in Patients With Stage I, Stage II, or Stage III Non-small Cell Lung Cancer That Can Be Removed by Surgery
Related Studies:
Other stage 3A non-small cell lung cancer Clinical Trials
Other New Jersey Clinical Trials
Other Hamilton Clinical Trials
Marimastat in Treating Patients With Stage III Non-small Cell Lung Cancer
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