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Sponsors and Collaborators: |
University of Pennsylvania National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00040768 |
RATIONALE: Bortezomib may interfere with the growth of tumor cells by blocking certain enzymes necessary for tumor cell growth.
PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who have stage IIIB, stage IV, or recurrent non-small cell lung cancer.
Condition | Intervention | Phase |
---|---|---|
Lung Cancer |
Drug: bortezomib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study Of PS-341 In Metastatic Non-Small Cell Lung Cancer |
Study Start Date: | February 2002 |
OBJECTIVES:
OUTLINE: Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who received prior bortezomib and achieved at least a partial response of at least 6 months duration may also receive therapy as above.
PROJECTED ACCRUAL: A total of 23-35 patients will be accrued for this study within 4-14 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
No more than 1 prior chemotherapy regimen
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Pennsylvania | |
Abramson Cancer Center of the University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104-4283 |
Study Chair: | Tracey Evans, MD | University of Pennsylvania |
Study ID Numbers: | CDR0000069405, UPCC-06501, NCI-5763 |
Study First Received: | July 8, 2002 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00040768 History of Changes |
Health Authority: | United States: Federal Government |
recurrent non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer |
Thoracic Neoplasms Respiratory Tract Diseases Lung Neoplasms Lung Diseases Bortezomib Non-small Cell Lung Cancer |
Carcinoma, Non-Small-Cell Lung Recurrence Protease Inhibitors Neoplasms, Glandular and Epithelial Carcinoma |
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Bortezomib Enzyme Inhibitors Pharmacologic Actions Protease Inhibitors |
Carcinoma Neoplasms Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |