Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00112840
Status:
COMPLETED
Last Update Posted:
2022-02-01
First Post:
2005-06-02
Brief Title:
CCI-779 and Bevacizumab in Treating Patients With Metastatic or Unresectable Kidney Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Trial of CCI-779 and Bevacizumab in Stage IV Renal Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2022-01
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:
This phase III trial is studying the side effects and best dose of CCI-779 and bevacizumab and to see how well they work in treating patients with metastatic or unresectable kidney cancer Drugs used in chemotherapy such as CCI-779 work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Monoclonal antibodies such as bevacizumab can block tumor growth in different ways Some find tumor cells and kill them or carry tumor-killing substances to them Others interfere with the ability of tumor cells to grow and spread Bevacizumab may also stop the growth of kidney cancer by blocking blood flow to the tumor Giving CCI-779 together with bevacizumab may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I To determine the maximally tolerated dose MTD and recommended dosing for the combination of CCI-779 and Bevacizumab in patients with metastatic renal cell cancer Phase I II To determine the proportion of patients with metastatic renal cell cancer who are progression free at 6 months Phase II
SECONDARY OBJECTIVES
I To determine the toxicity of the combination of CCI 779 and Bevacizumab in patients with metastatic renal cell cancer Phase II II To determine the clinical response rate of CCI 779 and Bevacizumab in patients with metastatic renal cell cancer Phase II III To determine the time to progression TTP disease free survival and overall survival of CCI 779 and Bevacizumab in patients with metastatic renal cell cancer Phase II
TERTIARY OBJECTIVES
I To identify predictive molecular markers of response both at the tumor level and in the plasmaserum level in an exploratory manner
II To correlate blood markers of angiogenesis with clinical activity of the combination of CCI-779 and Bevacizumab
OUTLINE This is a multicenter phase I dose-escalation study followed by a phase II study Patients are stratified according to study phase I vs II
Phase I Patients receive CCI-779 IV on days 1 8 15 and 22 and bevacizumab IV on days 1 and 15
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of CCI-779 and bevacizumab 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 Phase II Patients receive CCI-779 and bevacizumab as in phase I at the MTD determined in phase I After completion of study treatment patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after study entry
I To determine the maximally tolerated dose MTD and recommended dosing for the combination of CCI-779 and Bevacizumab in patients with metastatic renal cell cancer Phase I II To determine the proportion of patients with metastatic renal cell cancer who are progression free at 6 months Phase II
SECONDARY OBJECTIVES
I To determine the toxicity of the combination of CCI 779 and Bevacizumab in patients with metastatic renal cell cancer Phase II II To determine the clinical response rate of CCI 779 and Bevacizumab in patients with metastatic renal cell cancer Phase II III To determine the time to progression TTP disease free survival and overall survival of CCI 779 and Bevacizumab in patients with metastatic renal cell cancer Phase II
TERTIARY OBJECTIVES
I To identify predictive molecular markers of response both at the tumor level and in the plasmaserum level in an exploratory manner
II To correlate blood markers of angiogenesis with clinical activity of the combination of CCI-779 and Bevacizumab
OUTLINE This is a multicenter phase I dose-escalation study followed by a phase II study Patients are stratified according to study phase I vs II
Phase I Patients receive CCI-779 IV on days 1 8 15 and 22 and bevacizumab IV on days 1 and 15
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of CCI-779 and bevacizumab 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 Phase II Patients receive CCI-779 and bevacizumab as in phase I at the MTD determined in phase I After completion of study treatment patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after study entry
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 |
|---|---|---|---|
| N01CM62205 | NIH | CTEP | httpsreporternihgovquickSearchN01CM62205 |
| NCI-2009-00109 | REGISTRY | None | None |
| CDR0000428311 | None | None | None |
| NCI-6986 | None | None | None |
| MC0452 | OTHER | None | None |
| 6986 | OTHER | None | None |