Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00320073
Status:
COMPLETED
Last Update Posted:
2012-05-16
First Post:
2006-04-27
Brief Title:
Vinflunine and Erlotinib or Pemetrexed in Treating Patients With Unresectable or Metastatic Solid Tumors
Sponsor:
UNC Lineberger Comprehensive Cancer Center
Organization:
UNC Lineberger Comprehensive Cancer Center
Study Overview
Official Title:
A Two Arm Phase I Dose Escalation Trial of Vinflunine With Erlotinib or Pemetrexed in Refractory Solid Tumors
Status:
COMPLETED
Status Verified Date:
2012-05
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 vinflunine work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Erlotinib and pemetrexed may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Giving vinflunine together with erlotinib or pemetrexed may kill more tumor cells
PURPOSE This phase I trial is studying the side effects and best dose of vinflunine when given together with erlotinib or pemetrexed in treating patients with unresectable or metastatic solid tumors
PURPOSE This phase I trial is studying the side effects and best dose of vinflunine when given together with erlotinib or pemetrexed in treating patients with unresectable or metastatic solid tumors
Detailed Description:
OBJECTIVES
Primary
Define the maximum tolerated dose MTD of vinflunine and pemetrexed disodium in patients with unresectable or metastatic solid tumors
Define the MTD of vinflunine and erlotinib hydrochloride in these patients
Secondary
Determine the preliminary safety and efficacy reported descriptively per patient response tumor specific response rate reported if applicable of these regimens
Correlate CYP3A4 activity as measured by midazolam clearance with vinflunine plasma clearance
OUTLINE This is a nonrandomized open-label dose-escalation study Patients are assigned to 1 of 2 treatment groups
Group 1 Patients receive pemetrexed disodium IV over 10 minutes and vinflunine IV over 20 minutes on day 1
Cohorts of 3-6 patients receive escalating doses of pemetrexed disodium and vinflunine 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 Additional patients may be treated at the MTD
Group 2 Patients receive vinflunine IV over 20 minutes on day 1 and oral erlotinib hydrochloride once daily on days 2-21 of course 1 and on days 1-21 of all subsequent courses
Cohorts of 3-6 patients receive escalating doses of erlotinib hydrochloride and vinflunine until the 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 Additional patients may be treated at the MTD
In both groups courses repeat every 21 days in the absence of unacceptable toxicity
Blood samples are collected on day 1 of course 1 for pharmacodynamic studies
After completion of study treatment patients are followed for 30-40 days
Primary
Define the maximum tolerated dose MTD of vinflunine and pemetrexed disodium in patients with unresectable or metastatic solid tumors
Define the MTD of vinflunine and erlotinib hydrochloride in these patients
Secondary
Determine the preliminary safety and efficacy reported descriptively per patient response tumor specific response rate reported if applicable of these regimens
Correlate CYP3A4 activity as measured by midazolam clearance with vinflunine plasma clearance
OUTLINE This is a nonrandomized open-label dose-escalation study Patients are assigned to 1 of 2 treatment groups
Group 1 Patients receive pemetrexed disodium IV over 10 minutes and vinflunine IV over 20 minutes on day 1
Cohorts of 3-6 patients receive escalating doses of pemetrexed disodium and vinflunine 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 Additional patients may be treated at the MTD
Group 2 Patients receive vinflunine IV over 20 minutes on day 1 and oral erlotinib hydrochloride once daily on days 2-21 of course 1 and on days 1-21 of all subsequent courses
Cohorts of 3-6 patients receive escalating doses of erlotinib hydrochloride and vinflunine until the 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 Additional patients may be treated at the MTD
In both groups courses repeat every 21 days in the absence of unacceptable toxicity
Blood samples are collected on day 1 of course 1 for pharmacodynamic studies
After completion of study treatment patients are followed for 30-40 days
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 |
|---|---|---|---|
| CDR0000550148 | OTHER | PDQ number | None |