Ignite Creation Date:
2024-05-05 @ 5:10 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00408655
Status:
COMPLETED
Last Update Posted:
2014-06-19
First Post:
2006-12-06
Brief Title:
Temsirolimus Carboplatin and Paclitaxel in Treating Patients With Advanced Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Study of CCI-779 NSC 683864 in Combination With Carboplatin and Paclitaxel in Patients With Advanced Solid Tumours
Status:
COMPLETED
Status Verified Date:
2014-06
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:
This phase I trial is studying the side effects and best dose of temsirolimus carboplatin and paclitaxel in treating patients with advanced solid tumors Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Drugs used in chemotherapy such as carboplatin and paclitaxel work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving temsirolimus together with chemotherapy may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I Determine the maximum tolerated dose MTD and recommended phase II dose of temsirolimus carboplatin and paclitaxel in patients with advanced solid tumors
SECONDARY OBJECTIVES
I Determine the frequency and severity of toxic effects of this regimen in these patients
II Document any evidence of objective antitumor activity of this regimen in patients with measurable disease
III Determine the pharmacokinetic profile of carboplatin and paclitaxel alone temsirolimus alone and carboplatin paclitaxel and temsirolimus in combination in these patients
OUTLINE This is a multicenter open-label dose-escalation study Patients receive treatment in either part A or part B
PART A Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30-60 minutes on day 1 and temsirolimus IV over 30 minutes on days 8 and 15 Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity
PART B Patients receive paclitaxel and carboplatin as in part A They also receive temsirolimus IV over 30 minutes on days 1 and 8 Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients in parts A and B receive escalating doses of temsirolimus carboplatin and paclitaxel 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 The recommended phase II dose RPTD is the dose that is one dose level below the MTD Once the RPTD is determined in part A patients are enrolled in part B An expanded cohort of up to 10 patients with endometrial or ovarian cancer are treated at the RPTD determined in part B final RPTD
After completion of study treatment patients are followed at 4 weeks and then every 3 months thereafter
I Determine the maximum tolerated dose MTD and recommended phase II dose of temsirolimus carboplatin and paclitaxel in patients with advanced solid tumors
SECONDARY OBJECTIVES
I Determine the frequency and severity of toxic effects of this regimen in these patients
II Document any evidence of objective antitumor activity of this regimen in patients with measurable disease
III Determine the pharmacokinetic profile of carboplatin and paclitaxel alone temsirolimus alone and carboplatin paclitaxel and temsirolimus in combination in these patients
OUTLINE This is a multicenter open-label dose-escalation study Patients receive treatment in either part A or part B
PART A Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30-60 minutes on day 1 and temsirolimus IV over 30 minutes on days 8 and 15 Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity
PART B Patients receive paclitaxel and carboplatin as in part A They also receive temsirolimus IV over 30 minutes on days 1 and 8 Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients in parts A and B receive escalating doses of temsirolimus carboplatin and paclitaxel 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 The recommended phase II dose RPTD is the dose that is one dose level below the MTD Once the RPTD is determined in part A patients are enrolled in part B An expanded cohort of up to 10 patients with endometrial or ovarian cancer are treated at the RPTD determined in part B final RPTD
After completion of study treatment patients are followed at 4 weeks and then every 3 months thereafter
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 |
|---|---|---|---|
| NCI-2009-00691 | REGISTRY | None | None |
| CDR0000652060 | None | None | None |
| NCIC-179 | OTHER | CTEP | None |
| IND179 | OTHER | None | None |