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Paclitaxel and Pegylated Liposomal Doxorubicin for Treatment of HIV-related Kaposi Sarcoma

ConditionsKaposi SarcomaHIV-1-infectionAIDS-related Kaposi Sarcoma
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAIDS Malignancy Consortium

About this trial

This study is being done to determine if two different anti-cancer drugs, paclitaxel (PTX) and pegylated liposomal doxorubicin (PLD) have similar effects on treating Kaposi Sarcoma (KS) in people living with HIV (human immunodeficiency virus) in sub-Saharan Africa. Patients with HIV-related KS will receive either PTX or PLD once every 3 weeks for a total of six cycles.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

HIV-1 infection.

Histologically confirmed KS at any time prior to study entry, confirmed by an AIDS Malignancy Consortium (AMC)-certified pathologist.

Current stage T1 KS (irrespective of prior treatment with antiretroviral therapy (ART) OR

20 or more skin and/or oral KS lesions, and/or

Disqualifiers

Current acute, chronic, or recurrent infections that are serious, in the opinion of the site investigator, for which the participant has not completed at least 14 days of therapy before study entry and/or is not clinically stable.

Serious illness necessitating hospitalization/systemic treatment within 14 days prior to study entry

Breastfeeding or pregnant women are excluded because of potential risks of cytotoxic chemotherapy to an unborn child or infant.

Known history of congestive heart failure and/or systolic ejection fraction < 50%.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pegylated liposomal doxorubicin

    Drug

    PLD 20 mg/m2 on Day 1 of every 21-day cycle

  • Paclitaxel

    Drug

    PTX 100 mg/m2 on Day 1 of every 21-day cycle

Treatment groups

130 Participants
are divided into 2 treatment groups
Group A: Pegylated Liposomal DoxorubicinActive comparator 1 intervention
Group B: PaclitaxelActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Progression Free Survival at 48 weeks

Progression free survival (PFS) is defined as the length of time from enrollment into the study until disease progression or death. Disease progression will be assessed using the Kaposi Sarcoma Response Evaluation Criteria. Progressive disease is defined as: 1) 25% increase in the sum of perpendicular diameters of the indicator lesions; 2) 25% increase in the total number of KS lesions or the appearance of 5 new lesions; OR 3) 25% increase in the number of raised lesions

Time frame
48 weeks

Secondary outcomes

1

Frequency and severity of adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 in participants receiving PLD or PTX.

The frequency of adverse events that occur in patients receiving PLD will be compared with the frequency of adverse events in patients receiving PTX

Time frame
96 weeks
2

Objective response rate for AIDS-related KS in patients receiving PLD and PTX

The objective response rate is defined as the sum of the number of complete and partial responses in patients receiving PLD or PTX.

Time frame
96 weeks
3

Duration of Response in patients receiving PLD and PTX

Response duration is defined as the time from first documentation of complete or partial response as measured by KS response criteria to the documentation of first progression of disease as measured by KS response criteria

Time frame
96 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AIDS Malignancy Consortium

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: