Clinical trial NCT00290017: Study of Talabostat and Pemetrexed vs. Pemetrexed in Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC) After Failure of Platinum-Based Chemotherapy
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Carcinoma, Non-Small-Cell Lung
Lung Cancer
Neoplasms, Lung
Neoplasms, Pulmonary
Lead sponsor: Point Therapeutics
Sponsor class: INDUSTRY
First posted: 2006-02-10
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Marshall Schreeder, MD
state: Alabama
city: Phoenix
country: United States
facility: Hematology Oncology Associates
state: Arizona
city: Hot Springs
country: United States
facility: Heritage Physician Group-Oncology
state: Arkansas
city: Burbank
country: United States
facility: Raul R. Mena, MD
state: California
city: Fountain Valley
country: United States
facility: Pacific Coast Hematology / Oncology Medical Group, Inc.
state: California
city: Fountain Valley
country: United States
facility: Robert A. Moss, MD, FACP, Inc.
state: California
city: Lancaster
country: United States
facility: Antelope Valley Cancer Center
state: California
city: Oceanside
country: United States
facility: Warren Paroly, MD
state: California
city: Poway
country: United States
facility: Southwest Cancer Care Medical Group
state: California
city: Denver
country: United States
facility: Mile High Oncology
state: Colorado
city: Fairfield
country: United States
facility: Medical Specialists of Fairfield
state: Connecticut
city: Torrington
country: United States
facility: Northwestern Connecticut Oncology Hematology Associates, LLP
state: Connecticut
city: Gainesville
country: United States
facility: Lucio Gordan, MD
state: Florida
city: Lecanto
country: United States
facility: Cancer and Blood Disease Center
state: Florida
city: Ocala
country: United States
facility: Ocala Oncology Center
state: Florida
city: Ocoee
country: United States
facility: Cancer Center of Florida
state: Florida
city: Athens
country: United States
facility: Northeast Georgia Cancer Care, LLC
state: Georgia
city: Coeur d'Alene
country: United States
facility: North Idaho Cancer Center
state: Idaho
city: Chicago
country: United States
facility: Hematology Oncology Associates of Illinois
state: Illinois
city: Joliet
country: United States
facility: Joliet Oncology-Hematology Associates
state: Illinois
city: Indianapolis
country: United States
facility: American Health Network of Indiana--Hematology/Oncology
state: Indiana
city: Lafayette
country: United States
facility: Arnett Cancer Center
state: Indiana
city: South Bend
country: United States
facility: Northern Indiana Oncology Associates
state: Indiana
city: Terre Haute
country: United States
facility: Associated Physicians and Surgeons, LLC
state: Indiana
city: Terre Haute
country: United States
facility: HUX Cancer Center/Union Hospital
state: Indiana
city: Overland Park
country: United States
facility: Kansas City Cancer Center, LLC
state: Kansas
city: Hazard
country: United States
facility: Kentucky Cancer Clinic
state: Kentucky
city: Baltimore
country: United States
facility: Mercy Medical Center
state: Maryland
city: Glen Burnie
country: United States
facility: Chesapeake Oncology Hematology Associates (Tate Center)
state: Maryland
city: Westminster
country: United States
facility: Carroll County Cancer Center
state: Maryland
city: Worcester
country: United States
facility: Fallon Clinic, Inc. at Worcester Medical Center
state: Massachusetts
city: Clinton Township
country: United States
facility: Michael McKenzie, DO
state: Michigan
city: Port Huron
country: United States
facility: Youssef Hanna, MD
state: Michigan
city: Rochester Hills
country: United States
facility: Cancer and Transplant Consultants, PLC
state: Michigan
city: Rochester Hills
country: United States
facility: Cancer Care Associates
state: Michigan
city: Royal Oak
country: United States
facility: Cancer Care Associates, PC
state: Michigan
city: Royal Oak
country: United States
facility: Hematology Oncology Consultants
state: Michigan
city: Royal Oak
country: United States
facility: Jeffrey H. Margolis, MD
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Troy
country: United States
facility: Dr. Folbe, MD/PC
state: Michigan
city: Troy
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Burnsville
country: United States
facility: Minnesota Oncology Hematology, PA
state: Minnesota
city: Minneapolis
country: United States
facility: Minnesota Oncology Hematology, PA
state: Minnesota
city: St. Joseph
country: United States
facility: St. Joseph Oncology, Inc.
state: Missouri
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Reno
country: United States
facility: VA Sierra Nevada Health Care System
state: Nevada
city: Flemington
country: United States
facility: Hunterdon Regional Cancer Center
state: New Jersey
city: Long Branch
country: United States
facility: Monmouth Medical Center
state: New Jersey
city: Mount Holly
country: United States
facility: Hematology Oncology Associates, SJ, PA
state: New Jersey
city: Trenton
country: United States
facility: Capital Health System
state: New Jersey
city: Trenton
country: United States
facility: Mercer Bucks Oncology/Hematology
state: New Jersey
city: Albany
country: United States
facility: New York Oncology Hematology, PC
state: New York
city: Hickory
country: United States
facility: Northwestern Carolina Oncology & Hematology, PA
state: North Carolina
city: Winston Salem
country: United States
facility: Eugene Paschold, MD
state: North Carolina
city: Winston-Salem
country: United States
facility: Piedmont Hematology Oncology / Winston-Salem
state: North Carolina
city: Cincinnati
country: United States
facility: Oncology/Hematology Care, Inc.
state: Ohio
city: Kettering
country: United States
facility: Dayton Oncology & Hematology, PA
state: Ohio
city: Oklahoma City
country: United States
facility: Cancer Care Associates
state: Oklahoma
city: Tulsa
country: United States
facility: Cancer Care Associates
state: Oklahoma
city: Gettysburg
country: United States
facility: Satish A. Shah, MD
state: Pennsylvania
city: Kingston
country: United States
facility: Medical Oncology Associates of Wyoming Valley, PC
state: Pennsylvania
city: Langhorne
country: United States
facility: Hematology-Oncology Group, PC
state: Pennsylvania
city: Langhorne
country: United States
facility: St. Mary Medical Center--Research Center
state: Pennsylvania
city: Paoli
country: United States
facility: Paoli Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Rittenhouse Hematology Oncology Associates
state: Pennsylvania
city: Pottstown
country: United States
facility: Pottstown Memorial Medical Center
state: Pennsylvania
city: Sellersville
country: United States
facility: Bux-Mont Oncology-Hematology
state: Pennsylvania
city: Sellersville
country: United States
facility: Grandview Hospital
state: Pennsylvania
city: Aiken
country: United States
facility: Cancer Care Institute of Carolina
state: South Carolina
city: Charleston
country: United States
facility: Charleston Hematology Oncology, PA
state: South Carolina
city: Spartanburg
country: United States
facility: Palmetto Hematology Oncology PC
state: South Carolina
city: Chattanooga
country: United States
facility: Associates in Oncology and Hematology
state: Tennessee
city: Johnson City
country: United States
facility: McLeod Cancer and Blood Center
state: Tennessee
city: Knoxville
country: United States
facility: University of Tennessee
state: Tennessee
city: Arlington
country: United States
facility: Texas Cancer Center
state: Texas
city: Austin
country: United States
facility: Texas Oncology Cancer Center
state: Texas
city: Dallas
country: United States
facility: Texas Cancer Center (Dallas Southwest)
state: Texas
city: Dallas
country: United States
facility: Mary Crowley Medical Research Center
state: Texas
city: Denton
country: United States
facility: Texas Cancer Center / Denton
state: Texas
city: El Paso
country: United States
facility: El Paso Cancer Treatment Center--East
state: Texas
city: El Paso
country: United States
facility: Texas Oncology, PA
state: Texas
city: Ft. Worth
country: United States
facility: Texas Oncology, PA
state: Texas
city: Ft. Worth
country: United States
facility: US Oncology Research and Clinical Pharmacy
state: Texas
city: Lubbock
country: United States
facility: Joe Arrington Cancer Research and Treatment Center
state: Texas
city: Mesquite
country: United States
facility: Texas Oncology, PA
state: Texas
city: Midland
country: United States
facility: Texas Oncology, PA / Allison Cancer Center
state: Texas
city: Odessa
country: United States
facility: West Texas Cancer Center
state: Texas
city: Paris
country: United States
facility: Paris Regional Cancer Center
state: Texas
city: Sugar Land
country: United States
facility: Texas Oncology Cancer Center--Sugar Land
state: Texas
city: Tyler
country: United States
facility: Tyler Cancer Center
state: Texas
city: Abingdon
country: United States
facility: Cancer Outreach Associates, PC / Outreach Clinical Trial Consortium LLC
state: Virginia
city: Fairfax
country: United States
facility: Fairfax Northern Virginia Hematology / Oncology, PC
state: Virginia
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Richmond
country: United States
facility: Virginia Physicians, Inc.
state: Virginia
city: Salem
country: United States
facility: Oncology & Hematology Associates of Southwest Virginia
state: Virginia
city: Everett
country: United States
facility: Luke Walker, MD
state: Washington
city: Kirkland
country: United States
facility: Cascade Cancer Center
state: Washington
city: Seattle
country: United States
facility: Puget Sound Cancer Centers
state: Washington
city: Spokane
country: United States
facility: Cancer Care Northwest
state: Washington
city: Vancouver
country: United States
facility: Northwest Cancer Specialists, PC
state: Washington
city: Milwaukee
country: United States
facility: Medical Consultants, Ltd.
state: Wisconsin
Study officials:
References: