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.)
Millennium Pharmaceuticals, Inc.
Information provided by:
Montefiore Medical Center Identifier:
First received: September 13, 2005
Last updated: December 7, 2007
Last verified: December 2007
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

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

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
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 identifier: NCT00200382

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.
Study Chair: Rasim Gucalp, M.D. Montefiore Medical Center
  More Information Identifier: NCT00200382     History of Changes
Other Study ID Numbers: Velcade 
Study First Received: September 13, 2005
Last Updated: December 7, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms processed this record on May 24, 2016