Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00021047
Status:
COMPLETED
Last Update Posted:
2012-03-08
First Post:
2001-07-11
Brief Title:
Epirubicin Carboplatin and Capecitabine in Treating Patients With Unresectable Locally Advanced Metastatic or Recurrent Solid Tumor
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Phase III Trial of Epirubicin Carboplatin Capecitabine in Adult Cancer Patients
Status:
COMPLETED
Status Verified Date:
2012-03
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 use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells
PURPOSE Phase III trial to study the effectiveness of combining epirubicin carboplatin and capecitabine in treating patients who have unresectable locally advanced metastatic or recurrent solid tumor
PURPOSE Phase III trial to study the effectiveness of combining epirubicin carboplatin and capecitabine in treating patients who have unresectable locally advanced metastatic or recurrent solid tumor
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose and the recommended phase II dose of capecitabine administered with epirubicin and carboplatin in patients with unresectable locally advanced metastatic or recurrent solid tumors
Determine the toxic effects of this regimen in these patients
Determine the pharmacokinetics PK of capecitabine and correlate these PK parameters with clinical toxicity of this regimen in these patients
Correlate end-of-infusion levels of epirubicin and its metabolites with epirubicin dose and clinical toxicity of this regimen in these patients
Determine the possible correlation between polymorphisms in the promoter region of the thymidylate synthase gene with clinical toxicity of this regimen in these patients
Determine the antitumor activity of this regimen in these patients
OUTLINE This is a dose-escalation study of capecitabine
Patients receive epirubicin IV over 2 hours and carboplatin IV over 30 minutes on day 1 and oral capecitabine twice daily on days 2-5 8-12 and 15-19 Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of capecitabine 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 Once the MTD is determined 24 additional patients are treated at the recommended phase II dose
PROJECTED ACCRUAL A total of 3-45 patients 24 patients for phase II will be accrued for this study within 2 years
Determine the maximum tolerated dose and the recommended phase II dose of capecitabine administered with epirubicin and carboplatin in patients with unresectable locally advanced metastatic or recurrent solid tumors
Determine the toxic effects of this regimen in these patients
Determine the pharmacokinetics PK of capecitabine and correlate these PK parameters with clinical toxicity of this regimen in these patients
Correlate end-of-infusion levels of epirubicin and its metabolites with epirubicin dose and clinical toxicity of this regimen in these patients
Determine the possible correlation between polymorphisms in the promoter region of the thymidylate synthase gene with clinical toxicity of this regimen in these patients
Determine the antitumor activity of this regimen in these patients
OUTLINE This is a dose-escalation study of capecitabine
Patients receive epirubicin IV over 2 hours and carboplatin IV over 30 minutes on day 1 and oral capecitabine twice daily on days 2-5 8-12 and 15-19 Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of capecitabine 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 Once the MTD is determined 24 additional patients are treated at the recommended phase II dose
PROJECTED ACCRUAL A total of 3-45 patients 24 patients for phase II will be accrued for this study within 2 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000068741 | None | None | None |
| NCI-01-C-0172 | None | None | None |
| MB-NAVY-00-07 | None | None | None |
| MB-NAVY-B01-008 | None | None | None |