Lung Cancer Clinical Trial
Official title:
A Phase 3, Randomized, Double-Blind, Multicenter Study of Talabostat and Pemetrexed vs. Pemetrexed and Placebo in Patients With Advanced (Stage IIIB/IV) Non-Small Cell Lung Cancer (NSCLC) After Failure of Platinum-Based Chemotherapy
NCT number | NCT00290017 |
Other study ID # | PTH-305 |
Secondary ID | |
Status | Terminated |
Phase | Phase 3 |
First received | February 9, 2006 |
Last updated | June 7, 2007 |
Start date | February 2006 |
Verified date | June 2007 |
Source | Point Therapeutics |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
This Phase 3 study will compare the efficacy of talabostat plus pemetrexed to pemetrexed plus placebo in patients with Stage IIIB/IV NSCLC who have failed a platinum-based chemotherapy regimen.
Status | Terminated |
Enrollment | 400 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Men or women age =18 years - 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: - More than 2 prior chemotherapy regimens - 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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Cancer Outreach Associates, PC / Outreach Clinical Trial Consortium LLC | Abingdon | Virginia |
United States | Cancer Care Institute of Carolina | Aiken | South Carolina |
United States | New York Oncology Hematology, PC | Albany | New York |
United States | Texas Cancer Center | Arlington | Texas |
United States | Northeast Georgia Cancer Care, LLC | Athens | Georgia |
United States | Texas Oncology Cancer Center | Austin | Texas |
United States | Mercy Medical Center | Baltimore | Maryland |
United States | Raul R. Mena, MD | Burbank | California |
United States | Minnesota Oncology Hematology, PA | Burnsville | Minnesota |
United States | Charleston Hematology Oncology, PA | Charleston | South Carolina |
United States | Associates in Oncology and Hematology | Chattanooga | Tennessee |
United States | Hematology Oncology Associates of Illinois | Chicago | Illinois |
United States | Oncology/Hematology Care, Inc. | Cincinnati | Ohio |
United States | Michael McKenzie, DO | Clinton Township | Michigan |
United States | North Idaho Cancer Center | Coeur d'Alene | Idaho |
United States | Mary Crowley Medical Research Center | Dallas | Texas |
United States | Texas Cancer Center (Dallas Southwest) | Dallas | Texas |
United States | Texas Cancer Center / Denton | Denton | Texas |
United States | Mile High Oncology | Denver | Colorado |
United States | El Paso Cancer Treatment Center--East | El Paso | Texas |
United States | Texas Oncology, PA | El Paso | Texas |
United States | Luke Walker, MD | Everett | Washington |
United States | Fairfax Northern Virginia Hematology / Oncology, PC | Fairfax | Virginia |
United States | Medical Specialists of Fairfield | Fairfield | Connecticut |
United States | Hunterdon Regional Cancer Center | Flemington | New Jersey |
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 | Texas Oncology, PA | Ft. Worth | Texas |
United States | US Oncology Research and Clinical Pharmacy | Ft. Worth | Texas |
United States | Lucio Gordan, MD | Gainesville | Florida |
United States | Satish A. Shah, MD | Gettysburg | Pennsylvania |
United States | Chesapeake Oncology Hematology Associates (Tate Center) | Glen Burnie | Maryland |
United States | Kentucky Cancer Clinic | Hazard | Kentucky |
United States | Northwestern Carolina Oncology & Hematology, PA | Hickory | North Carolina |
United States | Heritage Physician Group—Oncology | Hot Springs | Arkansas |
United States | Marshall Schreeder, MD | Huntsville | Alabama |
United States | American Health Network of Indiana--Hematology/Oncology | Indianapolis | Indiana |
United States | McLeod Cancer and Blood Center | Johnson City | Tennessee |
United States | Joliet Oncology-Hematology Associates | Joliet | Illinois |
United States | Dayton Oncology & Hematology, PA | Kettering | Ohio |
United States | Medical Oncology Associates of Wyoming Valley, PC | Kingston | Pennsylvania |
United States | Cascade Cancer Center | Kirkland | Washington |
United States | University of Tennessee | Knoxville | Tennessee |
United States | Arnett Cancer Center | Lafayette | Indiana |
United States | Antelope Valley Cancer Center | Lancaster | California |
United States | Hematology-Oncology Group, PC | Langhorne | Pennsylvania |
United States | St. Mary Medical Center--Research Center | Langhorne | Pennsylvania |
United States | Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada |
United States | Cancer and Blood Disease Center | Lecanto | Florida |
United States | Monmouth Medical Center | Long Branch | New Jersey |
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 | Medical Consultants, Ltd. | Milwaukee | Wisconsin |
United States | Minnesota Oncology Hematology, PA | Minneapolis | Minnesota |
United States | Hematology Oncology Associates, SJ, PA | Mount Holly | New Jersey |
United States | Virginia Oncology Associates | Norfolk | Virginia |
United States | Ocala Oncology Center | Ocala | Florida |
United States | Warren Paroly, MD | Oceanside | California |
United States | Cancer Center of Florida | Ocoee | Florida |
United States | West Texas Cancer Center | Odessa | Texas |
United States | Cancer Care Associates | Oklahoma City | Oklahoma |
United States | Kansas City Cancer Center, LLC | Overland Park | Kansas |
United States | Paoli Hospital | Paoli | Pennsylvania |
United States | Paris Regional Cancer Center | Paris | Texas |
United States | Rittenhouse Hematology Oncology Associates | Philadelphia | Pennsylvania |
United States | Hematology Oncology Associates | Phoenix | Arizona |
United States | Youssef Hanna, MD | Port Huron | Michigan |
United States | Pottstown Memorial Medical Center | Pottstown | Pennsylvania |
United States | Southwest Cancer Care Medical Group | Poway | California |
United States | VA Sierra Nevada Health Care System | Reno | Nevada |
United States | Virginia Physicians, Inc. | Richmond | Virginia |
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 | Oncology & Hematology Associates of Southwest Virginia | Salem | Virginia |
United States | Puget Sound Cancer Centers | Seattle | Washington |
United States | Bux-Mont Oncology-Hematology | Sellersville | Pennsylvania |
United States | Grandview Hospital | Sellersville | Pennsylvania |
United States | Northern Indiana Oncology Associates | South Bend | Indiana |
United States | Palmetto Hematology Oncology PC | Spartanburg | South Carolina |
United States | Cancer Care Northwest | Spokane | Washington |
United States | St. Joseph Oncology, Inc. | St. Joseph | Missouri |
United States | Texas Oncology Cancer Center--Sugar Land | Sugar Land | Texas |
United States | Associated Physicians and Surgeons, LLC | Terre Haute | Indiana |
United States | HUX Cancer Center/Union Hospital | Terre Haute | Indiana |
United States | Northwestern Connecticut Oncology Hematology Associates, LLP | Torrington | Connecticut |
United States | Capital Health System | Trenton | New Jersey |
United States | Mercer Bucks Oncology/Hematology | Trenton | New Jersey |
United States | Dr. Folbe, MD/PC | Troy | Michigan |
United States | William Beaumont Hospital | Troy | Michigan |
United States | Cancer Care Associates | Tulsa | Oklahoma |
United States | Tyler Cancer Center | Tyler | Texas |
United States | Northwest Cancer Specialists, PC | Vancouver | Washington |
United States | Carroll County Cancer Center | Westminster | Maryland |
United States | Eugene Paschold, MD | Winston Salem | North Carolina |
United States | Piedmont Hematology Oncology / Winston-Salem | Winston-Salem | North Carolina |
United States | Fallon Clinic, Inc. at Worcester Medical Center | Worcester | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Point Therapeutics |
United States,
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