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Sponsored by: |
University of California, Davis |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00389805 |
RATIONALE: Bortezomib and pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving bortezomib together with pemetrexed disodium may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of two different schedules of bortezomib when given together with pemetrexed disodium and to see how well they work in treating patients with advanced non-small cell lung cancer or other solid tumors.
Condition | Intervention | Phase |
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Lung Cancer Unspecified Adult Solid Tumor, Protocol Specific |
Drug: bortezomib Drug: pemetrexed disodium Procedure: flow cytometry Procedure: gene expression analysis Procedure: immunoenzyme technique Procedure: immunohistochemistry staining method Procedure: mutation analysis Procedure: protein expression analysis Procedure: reverse transcriptase-polymerase chain reaction |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase I/II Study of Two Different Schedules of Bortezomib (VELCADE, PS-341) and Pemetrexed (ALIMTA) in Advanced Solid Tumors, With Emphasis on Non-Small Cell Lung Cancer (NSCLC) |
Estimated Enrollment: | 86 |
Study Start Date: | March 2005 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Cytologically or histologically confirmed diagnosis of 1 of the following:
Stage IIIB (pleural effusion) or IV non-small cell lung cancer (NSCLC) (phase II)
Measurable disease
No symptomatic brain metastasis or disease requiring steroids and anticonvulsants
PATIENT CHARACTERISTICS:
No other prior malignancy except for the following (phase II):
No cardiovascular complications, including any of the following:
Electrocardiographic (ECG) evidence of acute ischemia or active conduction system abnormalities
PRIOR CONCURRENT THERAPY:
No concurrent anticonvulsants that are metabolized by the cytochrome P450 pathway, including any of the following:
Enzyme-inducing drugs
Enzyme-inhibiting drugs
United States, California | |
University of California Davis Cancer Center | |
Sacramento, California, United States, 95817 |
Study Chair: | Angela Davies, MD | University of California, Davis |
Study ID Numbers: | CDR0000505966, UCDCC-158, UCDCC-200412739-2 |
Study First Received: | October 18, 2006 |
Last Updated: | May 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00389805 |
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 unspecified adult solid tumor, protocol specific |
Folic Acid Pemetrexed Thoracic Neoplasms Non-small cell lung cancer Respiratory Tract Diseases Lung Neoplasms |
Lung Diseases Bortezomib Carcinoma, Non-Small-Cell Lung Recurrence Neoplasms, Glandular and Epithelial Carcinoma |
Antimetabolites Respiratory Tract Neoplasms Neoplasms by Histologic Type Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Enzyme Inhibitors |
Folic Acid Antagonists Pharmacologic Actions Protease Inhibitors Neoplasms Neoplasms by Site Therapeutic Uses |