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

This study has been terminated.
(The study did not achieve the statistical success to continue.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00200382
First Posted: September 20, 2005
Last Update Posted: December 11, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by:
Montefiore Medical Center
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Albert Einstein Cancer Center
Bronx, New York, United States, 10461
Jacobi Medical Center
Bronx, New York, United States, 10461
Montefiore Medical Center
Bronx, New York, United States, 10467
Sponsors and Collaborators
Montefiore Medical Center
Millennium Pharmaceuticals, Inc.
Investigators
Study Chair: Rasim Gucalp, M.D. Montefiore Medical Center
  More Information

ClinicalTrials.gov Identifier: NCT00200382     History of Changes
Other Study ID Numbers: Velcade
First Submitted: September 13, 2005
First Posted: September 20, 2005
Last Update Posted: December 11, 2007
Last Verified: December 2007

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Bortezomib
Antineoplastic Agents