Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00041171
Status:
WITHDRAWN
Last Update Posted:
2016-07-12
First Post:
2002-07-08
Brief Title:
Docetaxel and St Johns Wort in Treating Patients With Solid Tumors That Cannot Be Removed By Surgery
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Phase III Randomized Study of Hypericum Perforatum St Johns Wort Combined With Docetaxel in Patients With Unresectable Solid Tumors
Status:
WITHDRAWN
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was not activated
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 St Johns wort may interfere with the effectiveness of chemotherapy It is not yet known if chemotherapy is more effective with or without St Johns Wort in treating solid tumors
PURPOSE Randomized phase III trial to compare the effectiveness of docetaxel with or without St Johns wort in treating patients who have solid tumors that cannot be removed by surgery
PURPOSE Randomized phase III trial to compare the effectiveness of docetaxel with or without St Johns wort in treating patients who have solid tumors that cannot be removed by surgery
Detailed Description:
OBJECTIVES
Determine the effect of Hypericum perforatum St Johns Wort on the pharmacokinetic clearance of docetaxel in patients with unresectable solid tumors
Determine the effect of Hypericum perforatum on the production and plasma concentrations of M4-C13-hydroxydocetaxel in these patients
Determine the effects of this drug on the pharmacodynamics of docetaxel in these patients
Determine the relationship between the effects of this drug on docetaxel metabolic clearance and CYP3A4CYP3A5 genotype in these patients
Determine the relationship between the effect of this drug on docetaxel metabolic clearance and p-glycoprotein genotype in these patients
Determine the relationship between the effect of this drug on docetaxel clearance and pregnane receptor genotype in these patients
Assess compliance with this drug in these patients
Assess the steady state concentrations of hyperforin one of the putative psychoactive components of Hypericum perforatum in these patients
OUTLINE This is a randomized double-blind placebo-controlled study Patients who have not been receiving chronic Hypericum perforatum St Johns Wort are assigned to group A while a cohort of 8 patients who have been receiving chronic Hypericum perforatum are assigned to group B
Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral placebo three times daily on days 1-14 and docetaxel IV over 1 hour on day 15
Arm II Patients receive oral Hypericum perforatum three times daily on days 1-14 and docetaxel as in arm I
Group B non-randomized group Patients receive docetaxel as in arm I and continue to receive their chronic regimen of Hypericum perforatum except on day 15
Treatment in both groups repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity
Patients are followed for new primaries and survival only
PROJECTED ACCRUAL Approximately 92 patients will be accrued for this study
Determine the effect of Hypericum perforatum St Johns Wort on the pharmacokinetic clearance of docetaxel in patients with unresectable solid tumors
Determine the effect of Hypericum perforatum on the production and plasma concentrations of M4-C13-hydroxydocetaxel in these patients
Determine the effects of this drug on the pharmacodynamics of docetaxel in these patients
Determine the relationship between the effects of this drug on docetaxel metabolic clearance and CYP3A4CYP3A5 genotype in these patients
Determine the relationship between the effect of this drug on docetaxel metabolic clearance and p-glycoprotein genotype in these patients
Determine the relationship between the effect of this drug on docetaxel clearance and pregnane receptor genotype in these patients
Assess compliance with this drug in these patients
Assess the steady state concentrations of hyperforin one of the putative psychoactive components of Hypericum perforatum in these patients
OUTLINE This is a randomized double-blind placebo-controlled study Patients who have not been receiving chronic Hypericum perforatum St Johns Wort are assigned to group A while a cohort of 8 patients who have been receiving chronic Hypericum perforatum are assigned to group B
Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral placebo three times daily on days 1-14 and docetaxel IV over 1 hour on day 15
Arm II Patients receive oral Hypericum perforatum three times daily on days 1-14 and docetaxel as in arm I
Group B non-randomized group Patients receive docetaxel as in arm I and continue to receive their chronic regimen of Hypericum perforatum except on day 15
Treatment in both groups repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity
Patients are followed for new primaries and survival only
PROJECTED ACCRUAL Approximately 92 patients will be accrued for this study
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 |
|---|---|---|---|
| CDR0000069449 | REGISTRY | PDQ Physician Data Query | None |