Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00138177
Status:
COMPLETED
Last Update Posted:
2013-09-30
First Post:
2005-08-29
Brief Title:
Suberoylanilide Hydroxamic Acid Fluorouracil Leucovorin and Oxaliplatin in Treating Patients With Progressive Metastatic or Unresectable Colorectal Cancer or Other Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of Suberoylanilide Hydroxamic Acid Vorinostat in Combination With 5-Fluorouracil Leucovorin and Oxaliplatin mFOLFOX in Patients With Colorectal Cancer and Other Solid Tumors
Status:
COMPLETED
Status Verified Date:
2013-09
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 suberoylanilide hydroxamic acid when given together with fluorouracil leucovorin and oxaliplatin in treating patients with progressive metastatic or unresectable colorectal cancer or solid tumor Drugs used in chemotherapy such as suberoylanilide hydroxamic acid fluorouracil leucovorin and oxaliplatin work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Suberoylanilide hydroxamic acid may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Giving more than one drug combination chemotherapy may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I Determine the maximum tolerated dose of suberoylanilide hydroxamic acid when administered with fluorouracil leucovorin calcium and oxaliplatin in patients with progressive metastatic or unresectable colorectal cancer or other solid tumors
SECONDARY OBJECTIVES
I Determine the toxicity of this regimen in these patients II Determine the pharmacokinetics of oxaliplatin fluorouracil and suberoylanilide hydroxamic acid in these patients
OUTLINE This is a dose-escalation study of suberoylanilide hydroxamic acid SAHA
Patients receive oral SAHA once or twice daily on days 1-3 Patients also receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 4 followed by fluorouracil IV over 46 hours on days 4-5 Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of SAHA 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 A total of 10 patients are treated at the MTD
After completion of study treatment patients are followed for 4 weeks
I Determine the maximum tolerated dose of suberoylanilide hydroxamic acid when administered with fluorouracil leucovorin calcium and oxaliplatin in patients with progressive metastatic or unresectable colorectal cancer or other solid tumors
SECONDARY OBJECTIVES
I Determine the toxicity of this regimen in these patients II Determine the pharmacokinetics of oxaliplatin fluorouracil and suberoylanilide hydroxamic acid in these patients
OUTLINE This is a dose-escalation study of suberoylanilide hydroxamic acid SAHA
Patients receive oral SAHA once or twice daily on days 1-3 Patients also receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 4 followed by fluorouracil IV over 46 hours on days 4-5 Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of SAHA 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 A total of 10 patients are treated at the MTD
After completion of study treatment patients are followed for 4 weeks
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 |
|---|---|---|---|
| 6789 | OTHER | CTEP | None |
| NCI-2009-00083 | REGISTRY | None | None |
| CDR0000439445 | None | None | None |
| I 55305 | OTHER | None | None |