← Back to Search

Anthracycline

Arm I (paclitaxel) for Kaposi Sarcoma

Phase 3
Waitlist Available
Led By Jamie Von Roenn
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 8 years
Awards & highlights

Study 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

Eligible Conditions
  • Kaposi Sarcoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 8 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-free survival
Secondary outcome measures
Complete response rate
HIV infection assessed with respect to HIV viral load
HIV infection assessed with respect to incidence and type of opportunistic infections
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm II (pegylated liposomal doxorubicin hydrochloride)Experimental Treatment3 Interventions
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.
Group II: Arm I (paclitaxel)Experimental Treatment3 Interventions
Patients receive paclitaxel over 3 hours by intravenous infusion. Treatment course repeats every 2 weeks. Patients are evaluated every third 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
FDA approved
Doxorubicin
FDA approved
quality-of-life assessment
2012
Completed Phase 3
~2780

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,717 Previous Clinical Trials
40,953,123 Total Patients Enrolled
Jamie Von RoennPrincipal InvestigatorEastern Cooperative Oncology Group
~9 spots leftby May 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top