Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00027898
Status:
COMPLETED
Last Update Posted:
2013-02-07
First Post:
2001-12-07
Brief Title:
Bortezomib and Combination Chemotherapy in Treating Patients With Advanced Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of PS-341 NSC 681239 Carboplatin and Etoposide in Patients With Advanced Solid Tumors Refractory to Standard Therapy
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:
Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for their growth Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Phase I trial to study the effectiveness of combining bortezomib with carboplatin and etoposide in treating patients who have advanced solid tumors that have not responded to previous treatment
Detailed Description:
PRIMARY OBJECTIVES
I Determine the maximum tolerated dose MTD of bortezomib carboplatin and etoposide in patients with advanced solid tumors refractory to standard therapy
II Evaluate biologic effects of bortezomib on relevant targets in the tumor tissues of patients treated with this regimen
OUTLINE This is a dose-escalation study of bortezomib etoposide and carboplatin
Patients receive bortezomib IV on days 1 and 8 carboplatin IV over 30 minutes on day 1 and etoposide IV over 60 minutes on days 1-3 Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity
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 or more of 6 patients experience dose-limiting toxicity Once the MTD is determined 6 additional patients with newly diagnosed chemotherapy-naive extensive stage small cell lung cancer and 6 patients with other tumor types are treated at that dose
PROJECTED ACCRUAL A total of 12-27 patients will be accrued for this study within 6-14 months
I Determine the maximum tolerated dose MTD of bortezomib carboplatin and etoposide in patients with advanced solid tumors refractory to standard therapy
II Evaluate biologic effects of bortezomib on relevant targets in the tumor tissues of patients treated with this regimen
OUTLINE This is a dose-escalation study of bortezomib etoposide and carboplatin
Patients receive bortezomib IV on days 1 and 8 carboplatin IV over 30 minutes on day 1 and etoposide IV over 60 minutes on days 1-3 Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity
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 or more of 6 patients experience dose-limiting toxicity Once the MTD is determined 6 additional patients with newly diagnosed chemotherapy-naive extensive stage small cell lung cancer and 6 patients with other tumor types are treated at that dose
PROJECTED ACCRUAL A total of 12-27 patients will be accrued for this study within 6-14 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 |
|---|---|---|---|
| COMIRB 01-288 | None | None | None |
| U01CA099176 | NIH | None | None |
| CDR0000069091 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU01CA099176 |