Phase II Study of Therapy With PS 341 in Patients With Advanced Stage Non Small Cell Lung Cancer

This study has been terminated.

Sponsors and Collaborators:	Montefiore Medical Center Millennium Pharmaceuticals, Inc.
Information provided by:	Montefiore Medical Center
ClinicalTrials.gov Identifier:	NCT00200382

Purpose

The purpose of this study is to develop new treatments that will hopefully result in the relief of symptoms and prolongation of life. For this reason, your doctors have offered you treatment with a new experimental drug called PS 341.

Condition	Intervention	Phase
Non-Small Cell Lung Cancer	Drug: PS-341 (Velcade-drug)	Phase II

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Bortezomib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase II Study to Evaluate the Efficacy and Safety of Therapy With PS 341 in Patients With Advanced Stage Non Small Cell Lung Cancer

Further study details as provided by Montefiore Medical Center:

Primary Outcome Measures:

Response rate

Estimated Enrollment:	27
Study Start Date:	May 2004
Study Completion Date:	May 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients must have confirmed NSCLC (squamous, adeno- and large cell anaplastic carcinoma)stage III B or Stage IV.

No prior chemotherapy regimen Patients must have adequate organ and marrow function

Exclusion Criteria:

Untreated symptomatic brain metastasis Patients with known HIV positivity

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00200382

Locations

United States, Massachusetts
HealthAlliance Hospitals
Fitchburg, Massachusetts, United States, 01420
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Albert Einstein Cancer Center
Bronx, New York, United States, 10461
Jacobi Medical Center
Bronx, New York, United States, 10461

Sponsors and Collaborators

Montefiore Medical Center

Millennium Pharmaceuticals, Inc.

Investigators

Study Chair:

Rasim Gucalp, M.D.

Montefiore Medical Center

More Information

Study ID Numbers:	Velcade
Study First Received:	September 13, 2005
Last Updated:	December 7, 2007
ClinicalTrials.gov Identifier:	NCT00200382
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases

Bortezomib
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009