Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00075751
Status:
COMPLETED
Last Update Posted:
2013-02-28
First Post:
2004-01-09
Brief Title:
Gemcitabine Carboplatin and Bortezomib in Advanced or Recurrent Non-Small Cell Lung Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial of Gemcitabine Carboplatin and PS-341 NSC-681239 in the First-Line Treatment of Advanced Non-Small Cell Lung Cancer NSCLC
Status:
COMPLETED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| S0339 | None | None | None |
| U10CA032102 | NIH | None | None |
| CDR0000349336 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU10CA032102 |