Study of Talabostat + Docetaxel Versus Docetaxel in Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC) After Failure of Platinum-Based Chemotherapy

This study has been terminated.
(FDA Hold May 2007)
Sponsor:
Information provided by:
Point Therapeutics
ClinicalTrials.gov Identifier:
NCT00243204
First received: October 19, 2005
Last updated: June 7, 2007
Last verified: June 2007
  Purpose

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.


Condition Intervention Phase
Carcinoma, Non-Small Cell Lung
Drug: talabostat mesylate
Drug: docetaxel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Point Therapeutics:

Estimated Enrollment: 400
Study Start Date: January 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00243204

  Hide Study Locations
Locations
United States, Alabama
Marshall Schreeder, MD
Huntsville, Alabama, United States, 35801
James P. Daugherty, MD
Muscle Shoals, Alabama, United States, 35661
United States, Alaska
Alaska Cancer Research
Anchorage, Alaska, United States, 99508
United States, Arizona
Hematology Oncology Associates
Phoenix, Arizona, United States, 85012
United States, California
Veena Charu, MD
Anaheim, California, United States, 92801
Lalita Pandit, MD, Inc
Fountain Valley, California, United States, 92708
Robert A. Moss, MD, FACP, Inc.
Fountain Valley, California, United States, 92708
Warren Paroly, MD
Oceanside, California, United States, 92056
Swarna S. Chanduri, MD
Pomona, California, United States, 91767
Southwest Cancer Care Medical Group
Poway, California, United States, 92064-2527
United States, Colorado
Mile High Oncology
Denver, Colorado, United States, 80210
Rocky Mountain Cancer Centers
Denver, Colorado, United States, 80218
United States, Connecticut
Medical Specialists of Fairfield
Fairfield, Connecticut, United States, 06824
United States, Florida
Pasco Hernando Oncology Associates PA
Brooksville, Florida, United States, 34613
Lucio Gordan, MD
Gainesville, Florida, United States, 32605
Citrus Hematology and Oncology Center
Inverness, Florida, United States, 34452
Nature Coast Clinical Research, LLC
Inverness, Florida, United States, 34452
Jorge G. Otoya, MD
Kissimmee, Florida, United States, 34741
Cancer and Blood Disease Center
Lecanto, Florida, United States, 34461
Pasco Hernando Oncology Associates, PA
New Port Richey, Florida, United States, 34652
Ocala Oncology Center
Ocala, Florida, United States, 34474
Cancer Center of Florida
Ocoee, Florida, United States, 34761
United States, Illinois
Hematology Oncology Associates of Illinois
Chicago, Illinois, United States, 60611
University of Chicago
Chicago, Illinois, United States, 60637
Joliet Oncology Hematology Associates
Joliet, Illinois, United States, 60435
United States, Indiana
Indiana Hematology Oncology Consultants
Indianapolis, Indiana, United States, 46202
Northern Indiana Oncology Associates
South Bend, Indiana, United States, 46617
United States, Kansas
Kansas City Cancer Centers, Southwest
Overland Park, Kansas, United States, 66210
United States, Kentucky
Kentucky Cancer Clinic
Hazard, Kentucky, United States, 41701
United States, Louisiana
Medical Oncology, LLC
Baton Rouge, Louisiana, United States, 70809
United States, Maryland
Maryland Oncology Hematology, PA
Columbia, Maryland, United States, 21044
Chesapeake Oncology Hematology Associates (Tate Center)
Glen Burnie, Maryland, United States, 21061
United States, Michigan
Josephine Ford Cancer Center -- Downriver
Brownstown, Michigan, United States, 48183
Michael McKenzie, DO
Clinton Township, Michigan, United States, 48038
Henry Ford Medical Center -- Fairlane
Dearborn, Michigan, United States, 48126
Henry Ford Health System
Detroit, Michigan, United States, 48202
Youssef Hanna, MD
Port Huron, Michigan, United States, 48060
Cancer and Transplant Consultants, PLC
Rochester Hills, Michigan, United States, 48307
Cancer Care Associates
Rochester Hills, Michigan, United States, 48307
Cancer Care Associates, PC
Royal Oak, Michigan, United States, 48073
Hematology Oncology Consultants
Royal Oak, Michigan, United States, 48073
Jeffrey H. Margolis, MD
Royal Oak, Michigan, United States, 48073
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Michigan Hematology and Oncology Institute
Southgate, Michigan, United States, 48195
Oncology Care Associates, PLLC
St. Joseph, Michigan, United States, 49085
William Beaumont Hospital
Troy, Michigan, United States, 48085
Mitchell Folbe, MD, PC
Troy, Michigan, United States, 48085
Henry Ford Medical Center
West Bloomfield, Michigan, United States, 48322
United States, Missouri
St. Joseph Oncology, Inc.
St. Joseph, Missouri, United States, 64507
Arch Medical Services, Inc.
St. Louis, Missouri, United States, 63141
United States, Montana
Billings Clinic
Billings, Montana, United States, 59101
United States, Nevada
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89109
United States, New Jersey
The Center for Cancer and Hematologic Disease
Cherry Hill, New Jersey, United States, 08003
United States, New York
New York Oncology Hematology, PC
Albany, New York, United States, 12208
George A. Zervos, MD
Glen Head, New York, United States, 11545
United States, North Carolina
Northwestern Carolina Oncology Hematology
Hickory, North Carolina, United States, 28602
United States, Ohio
Gabrail Cancer Center
Canton, Ohio, United States, 44718
Oncology/Hematology Care, Inc.
Cincinnati, Ohio, United States, 45242
Gabrail Cancer Center
Dover, Ohio, United States, 44622
Dayton Hematology and Oncology
Kettering, Ohio, United States, 45409
Mukesh C. Bhatt, MD
Medina, Ohio, United States, 44256
Trilogy Cancer Center
Wooster, Ohio, United States, 44691
United States, Oklahoma
Cancer Care Associates
Oklahoma City, Oklahoma, United States, 73112
Cancer Care Associates
Tulsa, Oklahoma, United States, 74136
United States, Oregon
Northwest Cancer Specialists, Northrup
Portland, Oregon, United States, 97210
United States, Pennsylvania
Shatish A. Shah, MD
Gettysburg, Pennsylvania, United States, 17325
Medical Oncology Associates of Wyoming Valley, PC
Kingston, Pennsylvania, United States, 18704
Rittenhouse Hematology Oncology Associates
Philadelphia, Pennsylvania, United States, 19146
Chester County Hematology / Oncology Services
West Chester, Pennsylvania, United States, 19380
United States, South Carolina
Cancer Care Institute of Carolina
Aiken, South Carolina, United States, 29801
Charleston Hematology Oncology, PA
Charleston, South Carolina, United States, 29403
Palmetto Hematology Oncology, PC
Spartanburg, South Carolina, United States, 29303-3041
United States, Texas
Texas Cancer Center
Arlington, Texas, United States, 76014
Texas Oncology Cancer Center
Austin, Texas, United States, 78731
Texas Cancer Center (Dallas Southwest)
Dallas, Texas, United States, 75237
Mary Crowley Medical Research Center
Dallas, Texas, United States, 75246
Texas Cancer Center / Denton
Denton, Texas, United States, 76210
El Paso Cancer Treatment Center
El Paso, Texas, United States, 79915
US Oncology Research and Clinical Pharmacy
Ft. Worth, Texas, United States, 76177
Texas Oncology, PA
Ft. Worth, Texas, United States, 76104
Texas Cancer Center of Mesquite
Mesquite, Texas, United States, 75150
Allison Cancer Center
Midland, Texas, United States, 79701-5946
West Texas Cancer Center
Odessa, Texas, United States, 79761
Paris Regional Cancer Center
Paris, Texas, United States, 75460-5004
Texas Oncology Cancer Center--Sugar Land
Sugar Land, Texas, United States, 77479
United States, Virginia
Annandale-Fairfax Virginia Hematology Oncology, PC
Fairfax, Virginia, United States, 22031
Peninsula Cancer Institute
Gloucester, Virginia, United States, 23061
Peninsula Cancer Institute
Newport News, Virginia, United States, 23601
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
Oncology & Hematology Associates of Southwest Virginia, Inc.
Salem, Virginia, United States, 24153
Peninsula Cancer Institute
Williamsburg, Virginia, United States, 23185
Masoom Kandahari, MD, PC
Woodbridge, Virginia, United States, 22191
United States, Washington
Puget Sound Cancer Centers
Seattle, Washington, United States, 98133
Cancer Care Northwest Research
Spokane, Washington, United States, 99218
Jay L. Wittenkeller, MD
Spokane, Washington, United States, 99204
Northwest Cancer Specialists, PC
Vancouver, Washington, United States, 98684
Sponsors and Collaborators
Point Therapeutics
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00243204     History of Changes
Other Study ID Numbers: PTH-304
Study First Received: October 19, 2005
Last Updated: June 7, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Point Therapeutics:
Stage IIIb/IV non-small cell lung cancer
NSCLC
Lung Cancer

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014