Phase III Study of Paclitaxel Versus Liposomal Doxorubicin for the Treatment of Advanced AIDS-Associated Kaposi's Sarcoma
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 K.S.
II. To compare the toxicity profile of intravenous paclitaxel with liposomal doxorubicin in
patients with advanced AIDS-related K.S.
III. To compare the overall and complete response rate of intravenous paclitaxel with
liposomal doxorubicin in patients with advanced AIDS-related K.S.
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
K.S., 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 K.S.
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
OUTLINE: This is a randomized study. Patients are randomized to receive either paclitaxel
(arm I) or doxorubicin HCL liposome(arm 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
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
The group sequential method by O'Brien and Fleming for the two-sided test will be used. The significance level will be based on the type I error spending function of Lan and DeMets such that the overall significance level will be maintained at 0.05.
Time from randomization to progression or to death from any cause, assessed up to 8 years
Jamie Von Roenn
Eastern Cooperative Oncology Group
United States: Food and Drug Administration
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