Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003008
Status:
COMPLETED
Last Update Posted:
2023-06-15
First Post:
1999-11-01
Brief Title:
Paclitaxel in Treating Patients With AIDS-Related Kaposis Sarcoma
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
Pilot Study to Evaluate the Potential Interactions Between Paclitaxel and Protease Inhibitors in Patients With AIDS-Related Kaposis Sarcoma
Status:
COMPLETED
Status Verified Date:
2023-06
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of paclitaxel in treating patients with AIDS-related Kaposis sarcoma
PURPOSE Phase II trial to study the effectiveness of paclitaxel in treating patients with AIDS-related Kaposis sarcoma
Detailed Description:
OBJECTIVES
Determine whether the body distribution and plasma clearance of paclitaxel is affected by protease inhibitors eg indinavir ritonavir saquinavir mesylate or nelfinavir mesylate
OUTLINE Patients are stratified according to protease inhibitor treatment yes vs no prior paclitaxel yes vs no and prior doxorubicin or daunorubicin yes vs no
Patients receive paclitaxel IV over 3 hours on day 1 Treatment continues every 2 weeks for at least 1 course in the absence of disease progression or unacceptable toxicity Patients who previously received paclitaxel receive no more than 1 course during this study
PROJECTED ACCRUAL A total of 33 patients will be accrued for this study
Determine whether the body distribution and plasma clearance of paclitaxel is affected by protease inhibitors eg indinavir ritonavir saquinavir mesylate or nelfinavir mesylate
OUTLINE Patients are stratified according to protease inhibitor treatment yes vs no prior paclitaxel yes vs no and prior doxorubicin or daunorubicin yes vs no
Patients receive paclitaxel IV over 3 hours on day 1 Treatment continues every 2 weeks for at least 1 course in the absence of disease progression or unacceptable toxicity Patients who previously received paclitaxel receive no more than 1 course during this study
PROJECTED ACCRUAL A total of 33 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 |
|---|---|---|---|
| AMC-014 | None | None | None |
| E1D95 | None | None | None |