Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002901
Status:
COMPLETED
Last Update Posted:
2010-01-13
First Post:
1999-11-01
Brief Title:
Docetaxel in Treating Patients With Solid Tumors and Abnormal Liver Function
Sponsor:
City of Hope Medical Center
Organization:
City of Hope Medical Center
Study Overview
Official Title:
PHASE I STUDY OF TAXOTERE IN PATIENTS WITH ADVANCED MALIGNANCIES AND VARYING DEGREES OF LIVER DYSFUNCTION
Status:
COMPLETED
Status Verified Date:
2010-01
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
PURPOSE Phase I trial to study the effectiveness of docetaxel in treating patients with advanced solid tumors that have not responded to standard therapy or for which there is no effective therapy
PURPOSE Phase I trial to study the effectiveness of docetaxel in treating patients with advanced solid tumors that have not responded to standard therapy or for which there is no effective therapy
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of docetaxel in patients with advanced solid tumors and varying degrees of liver dysfunction II Determine the effects of liver dysfunction in these patients on the plasma pharmacokinetics and pharmacodynamics of this therapy III Determine the utility of indocyanine green clearance and lidocaine metabolism as indicators of hepatic elimination of docetaxel in these patients
OUTLINE This is a dose-escalation multicenter study Patients are stratified according to liver function normal vs mild vs moderate vs severe Patients receive docetaxel IV over 1 hour Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity Patients who achieve complete remission CR receive 2 additional courses past CR Within each abnormal liver function stratum cohorts of 3-6 patients receive escalating doses of docetaxel until the maximum tolerated dose is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity Within each abnormal liver function stratum more than 6 patients are treated at the MTD if possible Patients in the normal liver function stratum are included as control patients and are followed for toxicity but do not undergo dose escalation Patients are followed for survival
PROJECTED ACCRUAL A maximum of 45 patients will be accrued for this study within 12-18 months
OUTLINE This is a dose-escalation multicenter study Patients are stratified according to liver function normal vs mild vs moderate vs severe Patients receive docetaxel IV over 1 hour Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity Patients who achieve complete remission CR receive 2 additional courses past CR Within each abnormal liver function stratum cohorts of 3-6 patients receive escalating doses of docetaxel until the maximum tolerated dose is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity Within each abnormal liver function stratum more than 6 patients are treated at the MTD if possible Patients in the normal liver function stratum are included as control patients and are followed for toxicity but do not undergo dose escalation Patients are followed for survival
PROJECTED ACCRUAL A maximum of 45 patients will be accrued for this study within 12-18 months
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-T96-0028H | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA033572 |
| U01CA062505 | NIH | None | None |
| P30CA033572 | NIH | None | None |
| CHNMC-PHI-08 | None | None | None |
| CHNMC-IRB-96118 | None | None | None |
| LAC-USC-PHI-08 | None | None | None |