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:
Montefiore Medical Center
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by:
Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT00200382
First received: September 13, 2005
Last updated: December 7, 2007
Last verified: December 2007
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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 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:
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
No publications provided
| ClinicalTrials.gov 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 Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases |
Respiratory Tract Diseases Bortezomib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013