Ignite Creation Date:
2024-05-05 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00423865
Status:
COMPLETED
Last Update Posted:
2015-05-25
First Post:
2007-01-16
Brief Title:
Cisplatin and Everolimus in Treating Patients With Advanced Solid Tumors
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Phase I Study of Weekly Low-Dose Cisplatin Plus Escalating Doses of Oral RAD001Everolimus for Patients With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2012-09
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:
RATIONALE Drugs used in chemotherapy such as cisplatin work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Everolimus may also help cisplatin work better by making tumor cells more sensitive to the drug Giving cisplatin together with everolimus may kill more tumor cells
PURPOSE This phase I trial is studying the side effects and best dose of everolimus when given together with cisplatin in treating patients with advanced solid tumors or recurrent or metastatic solid tumors
PURPOSE This phase I trial is studying the side effects and best dose of everolimus when given together with cisplatin in treating patients with advanced solid tumors or recurrent or metastatic solid tumors
Detailed Description:
OBJECTIVES
Primary
Determine the recommended phase II dose of everolimus when administered with low-dose cisplatin in patients with advanced solid tumors
Secondary
Determine the safety and tolerability of this regimen in these patients
Describe the pharmacokinetics of this regimen in patients with advanced solid tumors
Assess the effects of this regimen on p53 and p21 immunohistochemistry assays of pre- and post-treatment tumor biopsies from patients with recurrent or metastatic solid tumors
OUTLINE This is a dose-escalation study of everolimus part A followed by a biological marker study part B
Part A closed to accrual as of 12009 Patients receive cisplatin IV over 30 minutes on days 1 8 and 15 and oral everolimus once daily on days 1-21 Treatment repeats every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of everolimus until the maximum tolerated dose MTD is determined The MTD is defined as the dose proceeding that at which 2 of 6 patients experience dose-limiting toxicity DLT during course 1 The recommended phase II dose is defined as the dose at which 1 of 6 patients experience DLT during course 1
Blood is drawn periodically on days 1 and 8 of course 1 for pharmacokinetic studies
NOTE Patients who have completed 5 courses of treatment and maintain stable disease or better may continue treatment with everolimus alone or in combination with cisplatin
Part B Patients undergo biopsy of the primary tumor metastatic deposit or involved lymph node No more than 14 days later patients receive everolimus at the recommended phase II dose and cisplatin as in part A
Patients undergo another tumor biopsy on day 15 of course 1 before receiving chemotherapy The pre- and post-therapy tissue is examined by immunochemistry and analyzed for p53 and p21 expression
PROJECTED ACCRUAL A total of 30 people will be accrued for this study
Primary
Determine the recommended phase II dose of everolimus when administered with low-dose cisplatin in patients with advanced solid tumors
Secondary
Determine the safety and tolerability of this regimen in these patients
Describe the pharmacokinetics of this regimen in patients with advanced solid tumors
Assess the effects of this regimen on p53 and p21 immunohistochemistry assays of pre- and post-treatment tumor biopsies from patients with recurrent or metastatic solid tumors
OUTLINE This is a dose-escalation study of everolimus part A followed by a biological marker study part B
Part A closed to accrual as of 12009 Patients receive cisplatin IV over 30 minutes on days 1 8 and 15 and oral everolimus once daily on days 1-21 Treatment repeats every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of everolimus until the maximum tolerated dose MTD is determined The MTD is defined as the dose proceeding that at which 2 of 6 patients experience dose-limiting toxicity DLT during course 1 The recommended phase II dose is defined as the dose at which 1 of 6 patients experience DLT during course 1
Blood is drawn periodically on days 1 and 8 of course 1 for pharmacokinetic studies
NOTE Patients who have completed 5 courses of treatment and maintain stable disease or better may continue treatment with everolimus alone or in combination with cisplatin
Part B Patients undergo biopsy of the primary tumor metastatic deposit or involved lymph node No more than 14 days later patients receive everolimus at the recommended phase II dose and cisplatin as in part A
Patients undergo another tumor biopsy on day 15 of course 1 before receiving chemotherapy The pre- and post-therapy tissue is examined by immunochemistry and analyzed for p53 and p21 expression
PROJECTED ACCRUAL A total of 30 people will be accrued for this study
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 |
|---|---|---|---|
| MSKCC-06129 | None | None | None |