Ignite Creation Date:
2024-05-05 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00514228
Status:
COMPLETED
Last Update Posted:
2012-06-26
First Post:
2007-08-08
Brief Title:
Sunitinib in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery
Sponsor:
Swiss Group for Clinical Cancer Research
Organization:
Swiss Group for Clinical Cancer Research
Study Overview
Official Title:
Continuous Sunitinib Treatment in Patients With Unresectable Hepatocellular Carcinoma A Multicenter Phase II Trial
Status:
COMPLETED
Status Verified Date:
2012-06
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 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
PURPOSE This phase II trial is studying how well sunitinib works in treating patients with liver cancer that cannot be removed by surgery
PURPOSE This phase II trial is studying how well sunitinib works in treating patients with liver cancer that cannot be removed by surgery
Detailed Description:
OBJECTIVES
Primary
Demonstrate the antitumor activity of continuous sunitinib malate treatment in patients with unresectable hepatocellular carcinoma
Secondary
Evaluate the safety of sunitinib malate treatment
Measure serum cobalamin ie vitamin B12 level during sunitinib malate treatment in order to investigate the relationship between sunitinib malate treatment and cobalamin deficiency
Control the cobalamin deficiency by cobalamin replacement
Investigate whether changes in tumor density could be used as a criterion for tumor response in future trials
OUTLINE This is a multicenter study
Patients receive oral sunitinib malate once daily Treatment continues in the absence of disease progression or unacceptable toxicity
Patients undergo blood sample collection on day 1 of each course to assess serum cobalamin levels and correlation with sunitinib malate treatment Patients are also assessed for changes in tumor density and correlation with response Baseline CT scans are compared with scans performed at 6 and 12 weeks to evaluate changes in CT-scan density due to tumor necrosis and response
After completion of study therapy patients are followed at least every 3 months for up to 3 years
Primary
Demonstrate the antitumor activity of continuous sunitinib malate treatment in patients with unresectable hepatocellular carcinoma
Secondary
Evaluate the safety of sunitinib malate treatment
Measure serum cobalamin ie vitamin B12 level during sunitinib malate treatment in order to investigate the relationship between sunitinib malate treatment and cobalamin deficiency
Control the cobalamin deficiency by cobalamin replacement
Investigate whether changes in tumor density could be used as a criterion for tumor response in future trials
OUTLINE This is a multicenter study
Patients receive oral sunitinib malate once daily Treatment continues in the absence of disease progression or unacceptable toxicity
Patients undergo blood sample collection on day 1 of each course to assess serum cobalamin levels and correlation with sunitinib malate treatment Patients are also assessed for changes in tumor density and correlation with response Baseline CT scans are compared with scans performed at 6 and 12 weeks to evaluate changes in CT-scan density due to tumor necrosis and response
After completion of study therapy patients are followed at least every 3 months for up to 3 years
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 |
|---|---|---|---|
| SWS-SAKK-7706 | None | None | None |
| EU-20750 | None | None | None |
| EUDRACT-2007-003977-22 | None | None | None |
| CDR0000560441 | None | None | None |