Study of Talabostat and Pemetrexed vs. Pemetrexed in Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC) After Failure of Platinum-Based Chemotherapy

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00290017
• Other study ID #: PTH-305
• Status: Terminated
• Phase: Phase 3
• First received: February 9, 2006
• Last updated: June 7, 2007
• Start date: February 2006

Study information

• 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

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 400
• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms
• Neoplasms
• Neoplasms, Lung
• Neoplasms, Pulmonary

Intervention

Drug:
• talabostat

• pemetrexed

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Point Therapeutics

Country where clinical trial is conducted

United States,