Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00415116
Status:
COMPLETED
Last Update Posted:
2011-07-08
First Post:
2006-12-21
Brief Title:
Lenalidomide Docetaxel and Carboplatin in Treating Patients With Advanced Solid Tumors
Sponsor:
The Cleveland Clinic
Organization:
The Cleveland Clinic
Study Overview
Official Title:
Phase I Trial of Three-Weekly Docetaxel Carboplatin and Oral CC-5013 in Patients With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2006-11
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 Lenalidomide may stop the growth of solid tumors by blocking blood flow to the tumor Drugs used in chemotherapy such as docetaxel and carboplatin work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving lenalidomide together with docetaxel and carboplatin may kill more tumor cells
PURPOSE This phase I trial is studying the side effects and best dose of lenalidomide when given together with docetaxel and carboplatin in treating patients with advanced solid tumors
PURPOSE This phase I trial is studying the side effects and best dose of lenalidomide when given together with docetaxel and carboplatin in treating patients with advanced solid tumors
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose of lenalidomide when administered with docetaxel and carboplatin in patients with advanced solid tumors
Secondary
Determine the safety and toxic effects of this regimen in these patients
Determine preliminarily the clinical activity of this regimen in these patients
OUTLINE This is an open-label dose-escalation study of lenalidomide
Patients receive docetaxel IV over 1 hour followed by carboplatin IV on day 1 Patients also receive oral lenalidomide once daily on days 1-14 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 after completion of 6 courses of treatment may continue lenalidomide alone once daily on days 1-14 Patients whose disease is stable or responding after completing 2 or 4 courses and who are unable to tolerate further chemotherapy may continue lenalidomide alone once daily on days 1-14 at the investigators discretion Treatment with lenalidomide repeats every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of lenalidomide 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 An additional 6-8 patients are treated at the MTD
After completion of study treatment patients are followed every 3 months
PROJECTED ACCRUAL A total of 42 patients will be accrued for this study
Primary
Determine the maximum tolerated dose of lenalidomide when administered with docetaxel and carboplatin in patients with advanced solid tumors
Secondary
Determine the safety and toxic effects of this regimen in these patients
Determine preliminarily the clinical activity of this regimen in these patients
OUTLINE This is an open-label dose-escalation study of lenalidomide
Patients receive docetaxel IV over 1 hour followed by carboplatin IV on day 1 Patients also receive oral lenalidomide once daily on days 1-14 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 after completion of 6 courses of treatment may continue lenalidomide alone once daily on days 1-14 Patients whose disease is stable or responding after completing 2 or 4 courses and who are unable to tolerate further chemotherapy may continue lenalidomide alone once daily on days 1-14 at the investigators discretion Treatment with lenalidomide repeats every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of lenalidomide 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 An additional 6-8 patients are treated at the MTD
After completion of study treatment patients are followed every 3 months
PROJECTED ACCRUAL A total of 42 patients 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 |
|---|---|---|---|
| P30CA043703 | NIH | None | None |
| CASE-CCF-7216 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA043703 |