Paclitaxel Compared With Doxorubicin in Treating Patients With Advanced

Status Completed

Clinical Trial Summary

Randomized phase III trial to compare the effectiveness of paclitaxel with that of doxorubicin in treating patients who have advanced AIDS-related Kaposi's 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 Kaposi's sarcoma

Clinical Trial 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 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 benefit criteria.

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 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

AIDS-related Kaposi Sarcoma
AIDS-Related Opportunistic Infections
Sarcoma
Sarcoma, Kaposi

Clinical Trial Details

NCT number	NCT00003350
Study type	Interventional
Source	National Cancer Institute (NCI)
Contact
Status	Completed
Phase	Phase 3
Start date	March 1999

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03596918` - Evaluating Quality of Life in Patients With AIDS-Associated Kaposi Sarcoma Treated With Bleomycin and Vincristine
Not yet recruiting	`NCT05567601` - Doxil/Caelyx BE Study	Phase 1
Terminated	`NCT04893018` - NT-I7 for Kaposi Sarcoma in Patients With or Without HIV	Phase 1
Completed	`NCT00064142` - Halofuginone Hydrobromide in Treating Patients With HIV-Related Kaposi's Sarcoma	Phase 2
Terminated	`NCT00020683` - A Phase II Trial of COL-3 in Patients With HIV Related Kaposi's Sarcoma	Phase 2
Not yet recruiting	`NCT05411237` - Paclitaxel and Pegylated Liposomal Doxorubicin for Treatment of HIV-related Kaposi Sarcoma	Phase 3
Active, not recruiting	`NCT05510973` - Evaluation of Advanced HIV Disease Differentiated Care Model in Malawi	N/A
Recruiting	`NCT05510908` - Use of a Screening Tool to Describe HIV-Related Cancer Burden and Patient Characteristics in the AMC
Withdrawn	`NCT02137564` - Gamma Secretase Inhibitor PF-03084014 in Treating Patients With AIDS-Associated Kaposi Sarcoma	Phase 2
Completed	`NCT01016730` - Bortezomib in Treating Patients With Relapsed or Refractory AIDS-Related Kaposi Sarcoma	Phase 1
Withdrawn	`NCT00521092` - Sunitinib Malate in Treating East African Patients With Kaposi Sarcoma	Phase 2
Completed	`NCT01057121` - Lenalidomide in Treating Patients With AIDS-Associated Kaposi's Sarcoma	Phase 1/Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Paclitaxel Compared With Doxorubicin in Treating Patients With Advanced AIDS-Related Kaposi's Sarcoma

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms