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Sponsors and Collaborators: |
Southwest Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00068289 |
RATIONALE: Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.
PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who have recurrent or refractory extensive-stage small cell lung cancer that was previously treated with platinum-based chemotherapy (such as cisplatin, carboplatin, or oxaliplatin).
Condition | Intervention | Phase |
---|---|---|
Lung Cancer |
Drug: bortezomib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Trial of PS-341 (NSC-681239) in Patients With Platinum-Treated Extensive Stage Small Cell Lung Cancer |
Study Start Date: | September 2003 |
OBJECTIVES:
OUTLINE: Patients are stratified according to platinum-sensitivity status (platinum sensitive [temporarily closed to accrual as of 8/1/04] vs platinum refractory [temporarily closed to accrual as of 6/1/04]).
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 are followed every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 40-80 patients (20-40 per stratum) will be accrued for this study within 0.5-1 year.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed extensive stage small cell lung cancer
Measurable disease by plain radiographs, CT scan, or MRI
Must have received a prior platinum-based chemotherapy regimen and meet criteria for 1 of the following:
Brain and/or leptomeningeal metastases are allowed provided all of the following are true:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
At least 14 days since prior thoracic or other major surgery and recovered
Investigator: | Primo N. Lara, MD | University of California, Davis |
Investigator: | Angela Davies, MD | University of California, Davis |
Study ID Numbers: | CDR0000320527, SWOG-S0327 |
Study First Received: | September 10, 2003 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00068289 |
Health Authority: | United States: Federal Government |
extensive stage small cell lung cancer recurrent small cell lung cancer |
Thoracic Neoplasms Carcinoma, Neuroendocrine Bortezomib Recurrence Carcinoma Neuroendocrine Tumors Carcinoma, Small Cell Neuroectodermal Tumors |
Respiratory Tract Diseases Lung Neoplasms Lung Diseases Neoplasms, Germ Cell and Embryonal Neuroepithelioma Adenocarcinoma Neoplasms, Glandular and Epithelial |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Neoplasms, Nerve Tissue Enzyme Inhibitors Pharmacologic Actions Protease Inhibitors |