Clinical trial NCT00243204: Study of Talabostat + Docetaxel Versus Docetaxel in 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
Keywords: Stage IIIb/IV non-small cell lung cancer
NSCLC
Lung Cancer
Lead sponsor: Point Therapeutics
Sponsor class: INDUSTRY
First posted: 2005-10-21
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This Phase 3 study will compare the efficacy of talabostat plus docetaxel to docetaxel 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 or older
* 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
* Clinically significant laboratory abnormalities, specifically:

  * Total bilirubin ≥ institutional upper limit of normal (ULN)
  * Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥1.5 x ULN concomitant with alkaline phosphatase \>2.5 x ULN
  * Serum creatinine ≥2.0mg/dL
  * Absolute neutrophil count \<1500/μL or platelets \<100,000/μL
* Untreated or symptomatic brain metastases
* Any malignancy within the 5 years immediately prior to the first dose of study medication with the exception of basal cell or non-metastatic squamous cell carcinoma of the skin, and carcinoma in-situ of the cervix
* A history of severe hypersensitivity to drugs formulated with polysorbate 80
* 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 other investigational medication for NSCLC.
* Pregnancy or lactation. Women of childbearing potential and non-vasectomized men must agree to use a barrier method of contraception.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Marshall Schreeder, MD
state: Alabama
city: Muscle Shoals
country: United States
facility: James P. Daugherty, MD
state: Alabama
city: Anchorage
country: United States
facility: Alaska Cancer Research
state: Alaska
city: Phoenix
country: United States
facility: Hematology Oncology Associates
state: Arizona
city: Anaheim
country: United States
facility: Veena Charu, MD
state: California
city: Fountain Valley
country: United States
facility: Lalita Pandit, MD, Inc
state: California
city: Fountain Valley
country: United States
facility: Robert A. Moss, MD, FACP, Inc.
state: California
city: Oceanside
country: United States
facility: Warren Paroly, MD
state: California
city: Pomona
country: United States
facility: Swarna S. Chanduri, 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: Denver
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Fairfield
country: United States
facility: Medical Specialists of Fairfield
state: Connecticut
city: Brooksville
country: United States
facility: Pasco Hernando Oncology Associates PA
state: Florida
city: Gainesville
country: United States
facility: Lucio Gordan, MD
state: Florida
city: Inverness
country: United States
facility: Citrus Hematology and Oncology Center
state: Florida
city: Inverness
country: United States
facility: Nature Coast Clinical Research, LLC
state: Florida
city: Kissimmee
country: United States
facility: Jorge G. Otoya, MD
state: Florida
city: Lecanto
country: United States
facility: Cancer and Blood Disease Center
state: Florida
city: New Port Richey
country: United States
facility: Pasco Hernando Oncology Associates, PA
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: Chicago
country: United States
facility: Hematology Oncology Associates of Illinois
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Joliet
country: United States
facility: Joliet Oncology Hematology Associates
state: Illinois
city: Indianapolis
country: United States
facility: Indiana Hematology Oncology Consultants
state: Indiana
city: South Bend
country: United States
facility: Northern Indiana Oncology Associates
state: Indiana
city: Overland Park
country: United States
facility: Kansas City Cancer Centers, Southwest
state: Kansas
city: Hazard
country: United States
facility: Kentucky Cancer Clinic
state: Kentucky
city: Baton Rouge
country: United States
facility: Medical Oncology, LLC
state: Louisiana
city: Columbia
country: United States
facility: Maryland Oncology Hematology, PA
state: Maryland
city: Glen Burnie
country: United States
facility: Chesapeake Oncology Hematology Associates (Tate Center)
state: Maryland
city: Brownstown
country: United States
facility: Josephine Ford Cancer Center -- Downriver
state: Michigan
city: Clinton Township
country: United States
facility: Michael McKenzie, DO
state: Michigan
city: Dearborn
country: United States
facility: Henry Ford Medical Center -- Fairlane
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
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: Southgate
country: United States
facility: Michigan Hematology and Oncology Institute
state: Michigan
city: St. Joseph
country: United States
facility: Oncology Care Associates, PLLC
state: Michigan
city: Troy
country: United States
facility: Mitchell Folbe, MD, PC
state: Michigan
city: Troy
country: United States
facility: William Beaumont Hospital
state: Michigan
city: West Bloomfield
country: United States
facility: Henry Ford Medical Center
state: Michigan
city: St. Joseph
country: United States
facility: St. Joseph Oncology, Inc.
state: Missouri
city: St. Louis
country: United States
facility: Arch Medical Services, Inc.
state: Missouri
city: Billings
country: United States
facility: Billings Clinic
state: Montana
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Cherry Hill
country: United States
facility: The Center for Cancer and Hematologic Disease
state: New Jersey
city: Albany
country: United States
facility: New York Oncology Hematology, PC
state: New York
city: Glen Head
country: United States
facility: George A. Zervos, MD
state: New York
city: Hickory
country: United States
facility: Northwestern Carolina Oncology Hematology
state: North Carolina
city: Canton
country: United States
facility: Gabrail Cancer Center
state: Ohio
city: Cincinnati
country: United States
facility: Oncology/Hematology Care, Inc.
state: Ohio
city: Dover
country: United States
facility: Gabrail Cancer Center
state: Ohio
city: Kettering
country: United States
facility: Dayton Hematology and Oncology
state: Ohio
city: Medina
country: United States
facility: Mukesh C. Bhatt, MD
state: Ohio
city: Wooster
country: United States
facility: Trilogy Cancer Center
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: Portland
country: United States
facility: Northwest Cancer Specialists, Northrup
state: Oregon
city: Gettysburg
country: United States
facility: Shatish A. Shah, MD
state: Pennsylvania
city: Kingston
country: United States
facility: Medical Oncology Associates of Wyoming Valley, PC
state: Pennsylvania
city: Philadelphia
country: United States
facility: Rittenhouse Hematology Oncology Associates
state: Pennsylvania
city: West Chester
country: United States
facility: Chester County Hematology / Oncology Services
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: 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
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: Mesquite
country: United States
facility: Texas Cancer Center of Mesquite
state: Texas
city: Midland
country: United States
facility: 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: Fairfax
country: United States
facility: Annandale-Fairfax Virginia Hematology Oncology, PC
state: Virginia
city: Gloucester
country: United States
facility: Peninsula Cancer Institute
state: Virginia
city: Newport News
country: United States
facility: Peninsula Cancer Institute
state: Virginia
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Salem
country: United States
facility: Oncology & Hematology Associates of Southwest Virginia, Inc.
state: Virginia
city: Williamsburg
country: United States
facility: Peninsula Cancer Institute
state: Virginia
city: Woodbridge
country: United States
facility: Masoom Kandahari, MD, PC
state: Virginia
city: Seattle
country: United States
facility: Puget Sound Cancer Centers
state: Washington
city: Spokane
country: United States
facility: Jay L. Wittenkeller, MD
state: Washington
city: Spokane
country: United States
facility: Cancer Care Northwest Research
state: Washington
city: Vancouver
country: United States
facility: Northwest Cancer Specialists, PC
state: Washington
Study officials:
References: