Study of Talabostat and Pemetrexed vs. Pemetrexed in Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC) After Failure of Platinum-Based Chemotherapy
NCT ID: NCT00290017
Last Updated: 2007-06-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
400 participants
INTERVENTIONAL
2006-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Interventions
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talabostat
pemetrexed
Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically confirmed NSCLC (Recurrent, locally advanced or metastatic, inoperable NSCLC \[Stage IIIB/IV\]. Patients with Stage IIIB NSCLC must have a cytologically documented pleural effusion.)
* Failed or relapsed after receiving a platinum-containing chemotherapy regimen as first-line therapy for advanced NSCLC
* Measurable disease on computerized tomography (CT) scan
* ECOG Performance Status of 0 or 1
* Expected survival ≥12 weeks
* Provide written informed consent
Exclusion Criteria
* Progression of disease on prior pemetrexed treatment
* Brain metastases (exception: patients who had a resection and/or completed a course of cranial irradiation, have no worsening CNS symptoms, and have discontinued all corticosteroids for that indication for at least 1 month)
* Serum creatinine ≥2.0mg/dL or creatinine clearance \<45mL/min
* Absolute neutrophil count \<1500/μL or platelets \<100,000/μL
* Any malignancy within 5 years immediately prior to the first dose of study medication (exception: basal cell or non-metastatic squamous cell carcinoma of the skin, and carcinoma in-situ of the cervix)
* Any comorbidity or condition which, in the opinion of the investigator, may interfere with the assessments and procedures of this protocol
* Patients who are within 28 days of chemotherapy, radiation therapy, immunotherapy, or investigational medication for NSCLC. Patients must have recovered from all of the side effects of treatment.
* Pregnancy or lactation. Women of childbearing potential and non-vasectomized men must agree to use a barrier method of contraception during treatment.
18 Years
ALL
No
Sponsors
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Point Therapeutics
INDUSTRY
Locations
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Marshall Schreeder, MD
Huntsville, Alabama, United States
Hematology Oncology Associates
Phoenix, Arizona, United States
Heritage Physician Group-Oncology
Hot Springs, Arkansas, United States
Raul R. Mena, MD
Burbank, California, United States
Pacific Coast Hematology / Oncology Medical Group, Inc.
Fountain Valley, California, United States
Robert A. Moss, MD, FACP, Inc.
Fountain Valley, California, United States
Antelope Valley Cancer Center
Lancaster, California, United States
Warren Paroly, MD
Oceanside, California, United States
Southwest Cancer Care Medical Group
Poway, California, United States
Mile High Oncology
Denver, Colorado, United States
Medical Specialists of Fairfield
Fairfield, Connecticut, United States
Northwestern Connecticut Oncology Hematology Associates, LLP
Torrington, Connecticut, United States
Lucio Gordan, MD
Gainesville, Florida, United States
Cancer and Blood Disease Center
Lecanto, Florida, United States
Ocala Oncology Center
Ocala, Florida, United States
Cancer Center of Florida
Ocoee, Florida, United States
Northeast Georgia Cancer Care, LLC
Athens, Georgia, United States
North Idaho Cancer Center
Coeur d'Alene, Idaho, United States
Hematology Oncology Associates of Illinois
Chicago, Illinois, United States
Joliet Oncology-Hematology Associates
Joliet, Illinois, United States
American Health Network of Indiana--Hematology/Oncology
Indianapolis, Indiana, United States
Arnett Cancer Center
Lafayette, Indiana, United States
Northern Indiana Oncology Associates
South Bend, Indiana, United States
Associated Physicians and Surgeons, LLC
Terre Haute, Indiana, United States
HUX Cancer Center/Union Hospital
Terre Haute, Indiana, United States
Kansas City Cancer Center, LLC
Overland Park, Kansas, United States
Kentucky Cancer Clinic
Hazard, Kentucky, United States
Mercy Medical Center
Baltimore, Maryland, United States
Chesapeake Oncology Hematology Associates (Tate Center)
Glen Burnie, Maryland, United States
Carroll County Cancer Center
Westminster, Maryland, United States
Fallon Clinic, Inc. at Worcester Medical Center
Worcester, Massachusetts, United States
Michael McKenzie, DO
Clinton Township, Michigan, United States
Youssef Hanna, MD
Port Huron, Michigan, United States
Cancer and Transplant Consultants, PLC
Rochester Hills, Michigan, United States
Cancer Care Associates
Rochester Hills, Michigan, United States
Cancer Care Associates, PC
Royal Oak, Michigan, United States
Hematology Oncology Consultants
Royal Oak, Michigan, United States
Jeffrey H. Margolis, MD
Royal Oak, Michigan, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
Dr. Folbe, MD/PC
Troy, Michigan, United States
William Beaumont Hospital
Troy, Michigan, United States
Minnesota Oncology Hematology, PA
Burnsville, Minnesota, United States
Minnesota Oncology Hematology, PA
Minneapolis, Minnesota, United States
St. Joseph Oncology, Inc.
Saint Joseph, Missouri, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
VA Sierra Nevada Health Care System
Reno, Nevada, United States
Hunterdon Regional Cancer Center
Flemington, New Jersey, United States
Monmouth Medical Center
Long Branch, New Jersey, United States
Hematology Oncology Associates, SJ, PA
Mount Holly, New Jersey, United States
Capital Health System
Trenton, New Jersey, United States
Mercer Bucks Oncology/Hematology
Trenton, New Jersey, United States
New York Oncology Hematology, PC
Albany, New York, United States
Northwestern Carolina Oncology & Hematology, PA
Hickory, North Carolina, United States
Eugene Paschold, MD
Winston-Salem, North Carolina, United States
Piedmont Hematology Oncology / Winston-Salem
Winston-Salem, North Carolina, United States
Oncology/Hematology Care, Inc.
Cincinnati, Ohio, United States
Dayton Oncology & Hematology, PA
Kettering, Ohio, United States
Cancer Care Associates
Oklahoma City, Oklahoma, United States
Cancer Care Associates
Tulsa, Oklahoma, United States
Satish A. Shah, MD
Gettysburg, Pennsylvania, United States
Medical Oncology Associates of Wyoming Valley, PC
Kingston, Pennsylvania, United States
Hematology-Oncology Group, PC
Langhorne, Pennsylvania, United States
St. Mary Medical Center--Research Center
Langhorne, Pennsylvania, United States
Paoli Hospital
Paoli, Pennsylvania, United States
Rittenhouse Hematology Oncology Associates
Philadelphia, Pennsylvania, United States
Pottstown Memorial Medical Center
Pottstown, Pennsylvania, United States
Bux-Mont Oncology-Hematology
Sellersville, Pennsylvania, United States
Grandview Hospital
Sellersville, Pennsylvania, United States
Cancer Care Institute of Carolina
Aiken, South Carolina, United States
Charleston Hematology Oncology, PA
Charleston, South Carolina, United States
Palmetto Hematology Oncology PC
Spartanburg, South Carolina, United States
Associates in Oncology and Hematology
Chattanooga, Tennessee, United States
McLeod Cancer and Blood Center
Johnson City, Tennessee, United States
University of Tennessee
Knoxville, Tennessee, United States
Texas Cancer Center
Arlington, Texas, United States
Texas Oncology Cancer Center
Austin, Texas, United States
Texas Cancer Center (Dallas Southwest)
Dallas, Texas, United States
Mary Crowley Medical Research Center
Dallas, Texas, United States
Texas Cancer Center / Denton
Denton, Texas, United States
El Paso Cancer Treatment Center--East
El Paso, Texas, United States
Texas Oncology, PA
El Paso, Texas, United States
Texas Oncology, PA
Fort Worth, Texas, United States
US Oncology Research and Clinical Pharmacy
Fort Worth, Texas, United States
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, United States
Texas Oncology, PA
Mesquite, Texas, United States
Texas Oncology, PA / Allison Cancer Center
Midland, Texas, United States
West Texas Cancer Center
Odessa, Texas, United States
Paris Regional Cancer Center
Paris, Texas, United States
Texas Oncology Cancer Center--Sugar Land
Sugar Land, Texas, United States
Tyler Cancer Center
Tyler, Texas, United States
Cancer Outreach Associates, PC / Outreach Clinical Trial Consortium LLC
Abingdon, Virginia, United States
Fairfax Northern Virginia Hematology / Oncology, PC
Fairfax, Virginia, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
Virginia Physicians, Inc.
Richmond, Virginia, United States
Oncology & Hematology Associates of Southwest Virginia
Salem, Virginia, United States
Luke Walker, MD
Everett, Washington, United States
Cascade Cancer Center
Kirkland, Washington, United States
Puget Sound Cancer Centers
Seattle, Washington, United States
Cancer Care Northwest
Spokane, Washington, United States
Northwest Cancer Specialists, PC
Vancouver, Washington, United States
Medical Consultants, Ltd.
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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PTH-305
Identifier Type: -
Identifier Source: org_study_id