Pilot Study of Liposomal Doxorubicin Combined With Bevacizumab Followed by Bevacizumab Monotherapy in Adults With Advanced Kaposi s Sarcoma

Completed · Phase 2

Conditions studied: Sarcoma, Kaposi

In brief

Background: * The drug liposomal doxorubicin is approved by the U.S. Food and Drug Administration (FDA) for the treatment of Kaposi's sarcoma (KS). A second drug, bevacizumab, is a biologic agent (such as antibodies, interleukins, and vaccines) that stops abnormal blood supply to tumors. Bevacizumab is approved by the FDA, in combination with other drugs, for the treatment of breast cancer, colon cancer, and lung cancer. * Researchers are now studying the combination of liposomal doxorubicin with bevacizumab as a novel approach to the treatment of advanced KS. Researches will be measuring KS tumor responses to this combination to determine whether the drugs might have anti-KS activity. Objectives: * To estimate the overall response rate (ORR) of six cycles of liposomal doxorubicin combined with bevacizumab in patients with advanced KS. * To evaluate the safety of the regimen and to estimate the complete response rate after six cycles, the median number of cycles needed to obtain a partial response, and the 12-month progression-free survival. Eligibility: * Patients 18 years or older with relatively severe acquired immune deficiency syndrome (AIDS)-related KS or patients with KS unrelated to AIDS or human immunodeficiency virus (HIV) infection, whose KS that can be evaluated for potential response to therapy and meet a number of other criteria. * Women who are pregnant or breastfeeding are not eligible. * Other ineligibility criteria include surgery within 4 weeks, chemotherapy within 3 weeks, heart disease, hemoptysis (coughing up blood), or gastrointestinal bleeding. Design: * Researchers will conduct the following tests before the start of the study: * Physical examination and a detailed medical history. * A biopsy. * Blood and urine tests. * Treatment will include two phases, an induction phase and a maintenance phase: * Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles. * Monitoring will include a review of side effects, physical exam (including blood pressure), and blood and urine samples; following the induction phase, the patient will receive a multi gated acquisition scan and electrocardiography (EKG) to record electrical activity in the heart. * Research tests include blood and saliva samples, additional biopsies (optional), and noninvasive imaging. * Treatment is stopped if any of the following occur: completion of 1 year of therapy, progressive KS, patient preference, or unacceptable toxicity. * Post-treatment evaluations include clinic visits every 3 months or as needed up to 2 years, and blood and saliva samples (for research).

Key facts

Study ID: NCT00923936
Run by: National Cancer Institute (NCI)
People needed: 16
Starts: 2009-04-23
Expected to finish: 2017-11-08
Last updated by the study team: 2018-07-24

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

Inability to provide informed consent.
KS therapy other than HAART within 3 weeks.
History of cumulative doxorubicin or liposomal doxorubicin dose >430 mg/m(2).
Supraphysiologic doses of corticosteroids within 3 weeks.
Major surgical procedure (including periodontal) within 4 weeks.
Surgical or other non-healing wounds, other than KS ulcers.
Pregnancy (because of unknown potential for fetal malformation).
Breast feeding (because of unknown potential for adverse infant developmental consequences).
Has an uncontrolled illness including, but not limited to, ongoing or active infection requiring intravenous (IV) antibiotics, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, cirrhosis, or psychiatric illness/social situations that would limit adherence to study requirements.
Past or present history of malignant tumors other than KS unless: a) in a complete remission for greater than or equal to 1 year from the time a response was first documented; b) completely resected basal cell carcinoma; or c) in situ squamous cell carcinoma of the cervix or anus
Severe or life-threatening infection within 2 weeks of entry onto the study.
History of deep venous or arterial thrombotic disease (including but not limited to, acute myocardial infarction due to coronary thrombosis, ischemic stroke, and peripheral arterial disease), unless:
Line-related thrombosis without embolus
Occurring greater than or equal to 1 year prior to screening
Known procoagulant disorder including prothrombin gene mutation 20210, antithrombin III deficiency, protein c deficiency, protein S deficiency and antiphospholipid syndrome but not including heterozygosity for the Factor V Leiden mutation or the presence of a lupus anticoagulant in the absence of other criteria for the antiphospholipid syndrome.
Known bleeding diathesis.
History of severe gastrointestinal bleeding within 6 months. Patients with gastrointestinal blood loss due to KS may be included.
Hemoptysis within 4 weeks.
Substantial central nervous system (CNS) disease including.
History of CNS bleeding.
Mass lesions in the brain.
Uncontrolled seizure disorder.
Recent history of cerebrovascular accident (CVA) (e.g. within the past 6 months).
Proteinuria > 500 mg/24hrs.
Patients with any other abnormality that would be scored as a grade 3 or greater toxicity, except:

Where it is running

National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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