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Sponsored by: |
University of California, Davis |
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 |
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 |
MedlinePlus related topics: | Cancer Lung Cancer |
ChemIDplus related topics: | Pemetrexed disodium Pemetrexed Bortezomib |
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 |
Show Detailed Description |
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 |
University of California, Davis |
Study Chair: | Angela Davies, MD | University of California, Davis |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000505966, UCDCC-158, UCDCC-200412739-2 |
First Received: | October 18, 2006 |
Last Updated: | May 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00389805 |
Health Authority: | United States: Federal Government |
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