Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00052338
Status:
COMPLETED
Last Update Posted:
2013-01-23
First Post:
2003-01-24
Brief Title:
Bortezomib Plus Gemcitabine and Carboplatin in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study Of PS-341 In Combination With Gemcitabine And Carbloplatin In Selected Stage IIIB Or IV Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2013-01
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:
Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one chemotherapy drug and bortezomib may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I Determine the safety and feasibility of combining bortezomib with gemcitabine and carboplatin in patients with advanced or recurrent non-small cell lung cancer
II Determine the maximum tolerated dose of bortezomib administered in combination with gemcitabine and carboplatin in these patients
III Correlate results from laboratory studies on patient tissue and serum specimens with potential predictors of response in patients treated with this regimen
IV Determine preliminarily the response of patients treated with this regimen
OUTLINE This is a multicenter dose-escalation study of bortezomib
Patients receive gemcitabine IV over 30 minutes on days 1 and 8 carboplatin IV over 15-30 minutes on day 1 followed 1 hour later by 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 a clinical or radiographic response may continue receiving bortezomib beyond 6 courses
Cohorts of 3-6 patients receive escalating doses of bortezomib until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined at least 10 additional patients with chemotherapy-naive disease receive treatment as above with the MTD of bortezomib
Patients are followed for survival
I Determine the safety and feasibility of combining bortezomib with gemcitabine and carboplatin in patients with advanced or recurrent non-small cell lung cancer
II Determine the maximum tolerated dose of bortezomib administered in combination with gemcitabine and carboplatin in these patients
III Correlate results from laboratory studies on patient tissue and serum specimens with potential predictors of response in patients treated with this regimen
IV Determine preliminarily the response of patients treated with this regimen
OUTLINE This is a multicenter dose-escalation study of bortezomib
Patients receive gemcitabine IV over 30 minutes on days 1 and 8 carboplatin IV over 15-30 minutes on day 1 followed 1 hour later by 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 a clinical or radiographic response may continue receiving bortezomib beyond 6 courses
Cohorts of 3-6 patients receive escalating doses of bortezomib until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined at least 10 additional patients with chemotherapy-naive disease receive treatment as above with the MTD of bortezomib
Patients are followed for survival
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 |
|---|---|---|---|
| CDR0000258189 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchN01CM17101 |
| PHI-40 | None | None | None |
| N01CM17101 | NIH | None | None |