Sarcoma, KaposiPhase 2NCT00923936
Pilot Study of Liposomal Doxorubicin Combined With Bevacizumab Followed by Bevacizumab Monotherapy in Adults With Advanced Kaposi s Sarcoma
A Phase 2 study testing Liposomal Doxorubicin and Bevacizumab in people with Sarcoma, Kaposi, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Sarcoma, Kaposi
- What is being tested?
- Liposomal Doxorubicin and Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Apr 2009to 8 Nov 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
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- 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:
- Lymphopenia
- Direct manifestations of KS
- Direct manifestation of HIV
- Direct manifestation of HIV therapy (i.e. Hyperbilirubinemia associated with protease inhibitors)
- Asymptomatic hyperuricemia
- Hypophosphatemia
- Previous bevacizumab within 6 weeks prior to enrollment.
- Known hypersensitivity to bevacizumab, Chinese hamster ovary cell products, or other recombinant human or humanized antibodies.
- Any other condition, including the presence of laboratory abnormalities, which in the opinion of the Principal Investigator or Lead Associate Investigator, places the subject at unacceptable risk if there were to participate in the study or confounds the ability to interpret data from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
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.
Read more
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).
Read the detailed description
Background:
- Standard treatment for advanced Kaposi's sarcoma (KS) is a liposomal anthracycline, plus antiretroviral therapy (HAART) in patients with human immunodeficiency virus (HIV).
- KS is not curable and relapses are common. Prolonged use of liposomal anthracyclines with cumulative dosing exceeding 550 mg/m(2) is frequently required.
- KS is notable for pathogenic autocrine and paracrine vascular endothelial growth factor (VEGF) signaling. The monoclonal antibody, bevacizumab is a rational agent for the treatment of KS.
- Preliminary results from our phase II study of bevacizumab monotherapy, 03-C0110, suggest that bevacizumab has promising activity in the treatment of KS.
- The combination of anti-angiogenic therapy with cytotoxic chemotherapy has been a successful strategy in KS as well as other solid tumors.
- This pilot study will evaluate the activity and safety of liposomal doxorubicin combined with bevacizumab followed by bevacizumab maintenance in patients with advanced KS. A goal of this combination strategy is to develop a tolerable and highly active regimen that would limit the need for prolonged anthracycline use.
Objectives:
- The primary objective is to estimate the overall response rate (ORR) of six cycles of liposomal doxorubicin combined with bevacizumab in patients with advanced KS.
- Secondary objectives include evaluation of the safety of the regimen, as well as estimation of the complete response rate after 6 cycles, the median number of cycles need to obtain a partial response, and 12-month progression-free survival.
Eligibility:
Inclusion criteria:
- Age greater than or equal to 18
- Biopsy proven KS
- Indication for chemotherapy
- Any HIV status
- Normal multigated acquisition scan (MUGA)
- Able to tolerate aspirin 81 mg
- systolic blood pressure (SBP) <150, diastolic blood pressure (DBP) <90
- Urine protein <1+ or 500mg/24hrs
Exclusion Criteria:
- Surgery within 4 weeks
- Thrombo-embolic disease
- Chemotherapy within 3 weeks
- Hemoptysis or severe gastrointestinal bleeding, unless caused by KS
- Pregnancy or breast feeding
Design:
- This is an open label, single center pilot with 2 cohorts. Cohort 1: HIV negative, HIV infected with stable KS despite 1 year of HAART with HIV viremic control, or HIV infected with progressive KS despite 4 months of HAART with HIV viremic control. Cohort 2: All other patients with advanced AIDS-associated KS.
- Subjects will receive bevacizumab 15 mg/kg and liposomal doxorubicin 20 mg/m(2) every 3 weeks until complete response (CR) or a maximum of 6 cycles. Those with stable disease or better will continue on bevacizumab 15 mg/kg monotherapy every 3 weeks for 11 cycles. HIV infected subjects will receive HAART.
- ORR will be calculated with 80% CI for each cohort separately. If estimates in the two cohorts are similar (p>0.30 by a Fisher s exact test), they may be combined to form a somewhat more precise estimate of ORR after 6 cycles of treatment.
- A total of 10 evaluable patients will be accrued in each cohort.
- Conditions
- Sarcoma, Kaposi
- Being tested
- Liposomal Doxorubicin, Bevacizumab
- Keywords
- Kaposi's Sarcoma, HIV, Doxil, VEGF, Bevacizumab
- Medical subject headings
- Sarcoma, Kaposi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal DoxorubicinDrug
Also called Doxil
Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles.
BevacizumabDrug
Also called Avastin
Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles.
| Study group | Role | What they receive |
|---|---|---|
| KS;classic/HIV+not improved on antiviral | Active comparator | Kaposi's Sarcoma (KS) in patients who are Human immunodeficiency virus (HIV) Negative, HIV infected with stable disease for one year despite antiretroviral therapy or progressive disease despite 4 months of antiretroviral therapy. Receives: Drug: Liposomal Doxorubicin; Drug: Bevacizumab |
| All other advanced HIV-asociated KS | Active comparator | All other patients with advanced acquired immune deficiency syndrome (AIDS)-associated KS Receives: Drug: Liposomal Doxorubicin; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR) of Six Cycles of Liposomal Doxorubicin Combined With Bevacizumab in Patients With Advanced KS.
Overall response rate is complete response + clinical complete response + partial response. The overall response rate is the fraction of subjects with an overall response after 6 cycles of liposomal doxorubicin in combination with bevacizumab. Response was assessed by a modification of the Acquired Immune Deficiency Syndrome Clinical Trial Group Oncology Committee criteria. Complete response is the absence of any detectable residual disease, including tumor-associated edema, persisting for at least 4 weeks. Clinical complete response is the absence of any detectable residual disease, including tumor associated edema. persisting for at least 4 weeks. Partial response is no progressive disease (increase of 25% or more over baseline in the number of lesions and/or size (sum of the products of the largest perpendicular diameters of the marker lesions) \& noting that single lesions which split up into 2 or more smaller lesions during the course of treatment will still be counted as 1.
Measured: 6 cycles, an average of 18 weeks
Secondary outcomes (4)
Complete Response Rate After 6 Cycles of Liposomal Doxorubicin Combined With Bevacizumab
Complete response rate is the fraction of subjects with an complete response after 6 cycles of liposomal doxorubicin in combination with bevacizumab. Response was assessed by a modification of the Acquired Immune Deficiency Syndrome Clinical Trial Group Oncology Committee criteria. Complete response is the absence of any detectable residual disease, including tumor-associated edema, persisting for at least 4 weeks. In patients whom pigmented macular skin lesions persist after apparent complete response, biopsy of at least one representative lesion is required to document the absence of malignant cells. In patients known to have had visceral disease, an attempt at restaging with appropriate endoscopic or radiographic procedures should be made. If such procedures are medically contraindicated, the patient may be classified as having a clinical complete response.
Measured: 6 cycles, an average of 18 weeks
Count of Participants With Serious and Non-serious Adverse Events
Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Measured: 7 years and 6 months and 21 days
Median Number of Cycles Need to Obtain a Partial Response
Response was assessed by a modification of the Acquired Immune Deficiency Syndrome Clinical Trial Group Oncology Committee criteria. Partial response is no progressive disease (increase of 25% or more over baseline in the number of lesions and/or size (sum of the products of the largest perpendicular diameters of the marker lesions) and noting that single lesions which split up into 2 or more smaller lesions during the course of treatment will still be counted as 1; no new lesions occurring in previously uninvolved areas of the body; no new visceral sites of involvement or the appearance or worsening of tumor-associated edema or effusions and a 50% or greater decrease in the number and/or size of previously existing lesions lasting for at least 4 weeks or complete flattening of at least 50% of all previously raised lesions (i.e., 50% of all previously nodular or plaque-like lesions become macular) lasting for at least 4 weeks.
Measured: 6 cycles, an average of 18 weeks
Percentage of Participants With 12- Month Progression-free Survival (PFS)
Participants who survived and were progression free for 12 months. Response was assessed by a modification of the Acquired Immune Deficiency Syndrome Clinical Trial Group Oncology Committee criteria. Progressive disease is an increase of 25% or more over baseline in the number of lesions and/or size (sum of the products of the largest perpendicular diameters) of the marker lesions or a change in character from macular to plaque-like or nodular of at least 25% of the lesions or new visceral sites of involvement or progression of visceral disease or the development of new or increasing tumor-associated edema or effusion that lasts at least 1 week and interfered with the patient's normal activities.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2009 (estimated)
- Study start23 Apr 2009
- Primary completion13 May 2015
- Study completion8 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sarcoma, KaposiStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Principal investigator, Robert Yarchoan, National Institutes of Health Clinical Center (CC)
- Investigators
- Robert Yarchoan, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00923936
- Sponsor's protocol ID
- 090130
- Other IDs
- 09-C-0130
- Status last verified
- Jun 2018
- First submitted
- 17 Jun 2009
- Last updated
- 24 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Liposomal Doxorubicin Combined With Bevacizumab Followed by Bevacizumab Monotherapy in Adults With Advanced Kaposi s Sarcoma
- ClinicalTrials.gov ID
- NCT00923936
- Acronym / sponsor ID
- 090130
- Conditions
- Sarcoma, Kaposi
- Keywords
- Kaposi's Sarcoma, HIV, Doxil, VEGF, Bevacizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 23 Apr 2009 (actual)
- Primary completion
- 13 May 2015 (actual)
- Study completion
- 8 Nov 2017 (actual)
- First posted
- 18 Jun 2009 (estimated)
- Results
- Posted 16 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Background:
- Standard treatment for advanced Kaposi's sarcoma (KS) is a liposomal anthracycline, plus antiretroviral therapy (HAART) in patients with human immunodeficiency virus (HIV).
- KS is not curable and relapses are common. Prolonged use of liposomal anthracyclines with cumulative dosing exceeding 550 mg/m(2) is frequently required.
- KS is notable for pathogenic autocrine and paracrine vascular endothelial growth factor (VEGF) signaling. The monoclonal antibody, bevacizumab is a rational agent for the treatment of KS.
- Preliminary results from our phase II study of bevacizumab monotherapy, 03-C0110, suggest that bevacizumab has promising activity in the treatment of KS.
- The combination of anti-angiogenic therapy with cytotoxic chemotherapy has been a successful strategy in KS as well as other solid tumors.
- This pilot study will evaluate the activity and safety of liposomal doxorubicin combined with bevacizumab followed by bevacizumab maintenance in patients with advanced KS. A goal of this combination strategy is to develop a tolerable and highly active regimen that would limit the need for prolonged anthracycline use.
Objectives:
- The primary objective is to estimate the overall response rate (ORR) of six cycles of liposomal doxorubicin combined with bevacizumab in patients with advanced KS.
- Secondary objectives include evaluation of the safety of the regimen, as well as estimation of the complete response rate after 6 cycles, the median number of cycles need to obtain a partial response, and 12-month progression-free survival.
Eligibility:
Inclusion criteria:
- Age greater than or equal to 18
- Biopsy proven KS
- Indication for chemotherapy
- Any HIV status
- Normal multigated acquisition scan (MUGA)
- Able to tolerate aspirin 81 mg
- systolic blood pressure (SBP) <150, diastolic blood pressure (DBP) <90
- Urine protein <1+ or 500mg/24hrs
Exclusion Criteria:
- Surgery within 4 weeks
- Thrombo-embolic disease
- Chemotherapy within 3 weeks
- Hemoptysis or severe gastrointestinal bleeding, unless caused by KS
- Pregnancy or breast feeding
Design:
- This is an open label, single center pilot with 2 cohorts. Cohort 1: HIV negative, HIV infected with stable KS despite 1 year of HAART with HIV viremic control, or HIV infected with progressive KS despite 4 months of HAART with HIV viremic control. Cohort 2: All other patients with advanced AIDS-associated KS.
- Subjects will receive bevacizumab 15 mg/kg and liposomal doxorubicin 20 mg/m(2) every 3 weeks until complete response (CR) or a maximum of 6 cycles. Those with stable disease or better will continue on bevacizumab 15 mg/kg monotherapy every 3 weeks for 11 cycles. HIV infected subjects will receive HAART.
- ORR will be calculated with 80% CI for each cohort separately. If estimates in the two cohorts are similar (p>0.30 by a Fisher s exact test), they may be combined to form a somewhat more precise estimate of ORR after 6 cycles of treatment.
- A total of 10 evaluable patients will be accrued in each cohort.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KS;classic/HIV+not improved on antiviral | Active comparator | Drug: Liposomal Doxorubicin, Drug: BevacizumabKaposi's Sarcoma (KS) in patients who are Human immunodeficiency virus (HIV) Negative, HIV infected with stable disease for one year despite antiretroviral therapy or progressive disease despite 4 months of antiretroviral therapy. |
| All other advanced HIV-asociated KS | Active comparator | Drug: Liposomal Doxorubicin, Drug: BevacizumabAll other patients with advanced acquired immune deficiency syndrome (AIDS)-associated KS |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (34 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liposomal DoxorubicinAlso: DoxilInduction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles. | Drug | All other advanced HIV-asociated KS, KS;classic/HIV+not improved on antiviral |
| BevacizumabAlso: AvastinInduction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles. | Drug | All other advanced HIV-asociated KS, KS;classic/HIV+not improved on antiviral |
Primary outcome
Overall Response Rate (ORR) of Six Cycles of Liposomal Doxorubicin Combined With Bevacizumab in Patients With Advanced KS.
Time frame: 6 cycles, an average of 18 weeks
Overall response rate is complete response + clinical complete response + partial response. The overall response rate is the fraction of subjects with an overall response after 6 cycles of liposomal doxorubicin in combination with bevacizumab. Response was assessed by a modification of the Acquired Immune Deficiency Syndrome Clinical Trial Group Oncology Committee criteria. Complete response is the absence of any detectable residual disease, including tumor-associated edema, persisting for at least 4 weeks. Clinical complete response is the absence of any detectable residual disease, including tumor associated edema. persisting for at least 4 weeks. Partial response is no progressive disease (increase of 25% or more over baseline in the number of lesions and/or size (sum of the products of the largest perpendicular diameters of the marker lesions) \& noting that single lesions which split up into 2 or more smaller lesions during the course of treatment will still be counted as 1.
4 secondary outcomes
Complete Response Rate After 6 Cycles of Liposomal Doxorubicin Combined With Bevacizumab
Time frame: 6 cycles, an average of 18 weeks
Count of Participants With Serious and Non-serious Adverse Events
Time frame: 7 years and 6 months and 21 days
Median Number of Cycles Need to Obtain a Partial Response
Time frame: 6 cycles, an average of 18 weeks
Percentage of Participants With 12- Month Progression-free Survival (PFS)
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Yarchoan, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Liposomal Doxorubicin and Bevacizumab in people with Sarcoma, Kaposi, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) of Six Cycles of Liposomal Doxorubicin Combined With Bevacizumab in Patients With Advanced KS. (time frame: 6 cycles, an average of 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2018.