Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003350
Status:
COMPLETED
Last Update Posted:
2013-01-10
First Post:
1999-11-01
Brief Title:
Paclitaxel Compared With Doxorubicin in Treating Patients With Advanced AIDS-Related Kaposis Sarcoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase III Study of Paclitaxel Versus Liposomal Doxorubicin for the Treatment of Advanced AIDS-Associated Kaposis Sarcoma
Status:
COMPLETED
Status Verified Date:
2013-01
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:
Randomized phase III trial to compare the effectiveness of paclitaxel with that of doxorubicin in treating patients who have advanced AIDS-related Kaposis sarcoma Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die It is not yet known whether paclitaxel is more effective than doxorubicin in treating patients with advanced AIDS-related Kaposis sarcoma
Detailed Description:
PRIMARY OBJECTIVES
I To compare the effect of therapy with paclitaxel to therapy with liposomal doxorubicin on progression-free survival and on global assessment of quality of life of subjects with advanced AIDS-related KS
II To compare the toxicity profile of intravenous paclitaxel with liposomal doxorubicin in patients with advanced AIDS-related KS
III To compare the overall and complete response rate of intravenous paclitaxel with liposomal doxorubicin in patients with advanced AIDS-related KS
IV To evaluate the effect of intravenous paclitaxel as compared with therapy with liposomal doxorubicin on the clinical course of HIV infection in patients with advanced AIDS-related KS by monitoring CD4 and CD8 lymphocyte subsets HIV viral load and the incidence and type of opportunistic infections
V To explore the relationship between viral load and response to the therapy for patients with AIDS-related KS
VI To describe the relationship between technical response as measured by the current KS response criteria and the clinical benefit of therapy as measured by the revised KS clinical benefit criteria
OUTLINE This is a randomized study Patients are randomized to receive either paclitaxel arm I or doxorubicin HCL liposomearm II
Arm I Patients receive paclitaxel over 3 hours by intravenous infusion Treatment course repeats every 2 weeks Patients are evaluated every third course
Arm II Patients receive doxorubicin HCL liposome over 30-60 minutes by intravenous infusion Treatment course is repeated every 3 weeks Patients are evaluated before every odd course
Patients in both arms continue treatment if there is no disease progression or unacceptable toxicity Patients with complete response continue on study treatment for 2 courses beyond documented complete response
Quality of life is assessed before during and after treatment
Patients are followed every 3 months for the first 2 years then every 6 months for years 2-5 and then annually thereafter
PROJECTED ACCRUAL There will be 240 patients 120 patients in each arm accrued into this study over 24 months
I To compare the effect of therapy with paclitaxel to therapy with liposomal doxorubicin on progression-free survival and on global assessment of quality of life of subjects with advanced AIDS-related KS
II To compare the toxicity profile of intravenous paclitaxel with liposomal doxorubicin in patients with advanced AIDS-related KS
III To compare the overall and complete response rate of intravenous paclitaxel with liposomal doxorubicin in patients with advanced AIDS-related KS
IV To evaluate the effect of intravenous paclitaxel as compared with therapy with liposomal doxorubicin on the clinical course of HIV infection in patients with advanced AIDS-related KS by monitoring CD4 and CD8 lymphocyte subsets HIV viral load and the incidence and type of opportunistic infections
V To explore the relationship between viral load and response to the therapy for patients with AIDS-related KS
VI To describe the relationship between technical response as measured by the current KS response criteria and the clinical benefit of therapy as measured by the revised KS clinical benefit criteria
OUTLINE This is a randomized study Patients are randomized to receive either paclitaxel arm I or doxorubicin HCL liposomearm II
Arm I Patients receive paclitaxel over 3 hours by intravenous infusion Treatment course repeats every 2 weeks Patients are evaluated every third course
Arm II Patients receive doxorubicin HCL liposome over 30-60 minutes by intravenous infusion Treatment course is repeated every 3 weeks Patients are evaluated before every odd course
Patients in both arms continue treatment if there is no disease progression or unacceptable toxicity Patients with complete response continue on study treatment for 2 courses beyond documented complete response
Quality of life is assessed before during and after treatment
Patients are followed every 3 months for the first 2 years then every 6 months for years 2-5 and then annually thereafter
PROJECTED ACCRUAL There will be 240 patients 120 patients in each arm accrued into this study over 24 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 |
|---|---|---|---|
| CDR0000066331 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU10CA021115 |
| E1D96 | None | None | None |
| U10CA021115 | NIH | None | None |