Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00462553
Status:
COMPLETED
Last Update Posted:
2014-02-24
First Post:
2007-04-18
Brief Title:
Sunitinib and Gemcitabine in Treating Patients With Pancreatic Cancer or Other Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of Sunitinib Malate and Standard Infusion Gemcitabine in Solid Tumors
Status:
COMPLETED
Status Verified Date:
2013-04
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 sunitinib and gemcitabine in treating patients with pancreatic cancer or other solid tumors Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor Drugs used in hemotherapy such as gemcitabine work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving sunitinib together with gemcitabine may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I Determine the maximum tolerated dose MTD of sunitinib malate and gemcitabine hydrochloride in patients with adenocarcinoma of the pancreas or other solid tumors
II Determine the toxicity of this regimen in these patients
OUTLINE This is a dose-escalation study
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 OR on days 1 8 and 15 Patients also receive oral sunitinib malate once daily on days 1-21 OR days 1-28 Treatment repeats every 21 days OR every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of gemcitabine hydrochloride and sunitinib malate 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 Up to 10 patients may be treated at the recommended phase II dose RPTD which is generally the dose level below the maximally administered dose
After completion of study treatment patients are followed for 30 days and then periodically thereafter
I Determine the maximum tolerated dose MTD of sunitinib malate and gemcitabine hydrochloride in patients with adenocarcinoma of the pancreas or other solid tumors
II Determine the toxicity of this regimen in these patients
OUTLINE This is a dose-escalation study
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 OR on days 1 8 and 15 Patients also receive oral sunitinib malate once daily on days 1-21 OR days 1-28 Treatment repeats every 21 days OR every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of gemcitabine hydrochloride and sunitinib malate 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 Up to 10 patients may be treated at the recommended phase II dose RPTD which is generally the dose level below the maximally administered dose
After completion of study treatment patients are followed for 30 days and then periodically 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-2009-00212 | REGISTRY | None | None |
| CDR0000539459 | None | None | None |
| CASE 3206 | None | None | None |
| CASE 3206 | OTHER | None | None |
| 7731 | OTHER | None | None |
| U01CA062502 | NIH | CTEP | httpsreporternihgovquickSearchU01CA062502 |