Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2025-12-24 @ 11:41 PM
NCT ID:
NCT00075751
Brief Summary:
Phase II trial to study the effectiveness of combining bortezomib with gemcitabine and carboplatin in treating patients who have advanced or recurrent non-small cell lung cancer that has not been previously treated with chemotherapy. Drugs used in chemotherapy, such as gemcitabine and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Bortezomib may also help gemcitabine and carboplatin kill more tumor cells by making the cells more sensitive to the drugs
Detailed Description:
PRIMARY OBJECTIVES:
I. To assess overall survival in chemo-naϊve patients with advanced non-small cell lung cancer (NSCLC) treated with combination of gemcitabine, carboplatin and PS-341.
SECONDARY OBJECTIVES:
I. To assess response rate (confirmed plus unconfirmed, complete plus partial), in the subset of patients with measurable disease, progression-free survival and quantitative toxicities in this group of patients treated with this regimen.
II. To investigate in an exploratory manner, the association of levels of hypoxia-induced secreted proteins and tumor DNA in plasma levels of apoptosis-associated proteins in tumor tissue, and the changes in the levels of PS-341 modulated proteins in peripheral white blood cells with patient response and survival.
OUTLINE: This is a multicenter study.
Patients receive gemcitabine IV over 30 minutes on days 1 and 8, carboplatin IV over 15-30 minutes on day 1, and bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease may continue to receive bortezomib alone on the above schedule for up to 1 year at the discretion of the treating physician.
Patients are followed every 6 months for up to 3 years after registration.
PROJECTED ACCRUAL: A total of 99 patients will be accrued for this study within 5 months.
Study:
NCT00075751
Study Brief:
Protocol Section:
NCT00075751