We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00923936
First Posted: June 18, 2009
Last Update Posted: June 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Robert Yarchoan, National Institutes of Health Clinical Center (CC)
Results First Submitted: April 14, 2017  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Sarcoma, Kaposi
Interventions: Drug: Liposomal Doxorubicin
Drug: Bevacizumab

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
KS; Classic or HIV+ Not Improved on Antivirals

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.

Liposomal Doxorubicin: 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.

Bevacizumab: 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.

All Other Advanced HIV-associated Kaposi's Sarcoma (KS)

All other patients with advanced AIDS-associated KS

Liposomal Doxorubicin: 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.

Bevacizumab: 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.


Participant Flow:   Overall Study
    KS; Classic or HIV+ Not Improved on Antivirals   All Other Advanced HIV-associated Kaposi's Sarcoma (KS)
STARTED   10   6 
COMPLETED   2   3 
NOT COMPLETED   8   3 
progressive disease on study                2                1 
Adverse Event                2                1 
Lost to follow up                2                0 
Continuing in follow up period                2                1 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
KS; Classic or HIV+ Not Improved on Antivirals

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.

Liposomal Doxorubicin: 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.

Bevacizumab: 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.

All Other Advanced HIV-associated Kaposi's Sarcoma (KS)

All other patients with advanced AIDS-associated KS

Liposomal Doxorubicin: 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.

Bevacizumab: 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.

Total Total of all reporting groups

Baseline Measures
   KS; Classic or HIV+ Not Improved on Antivirals   All Other Advanced HIV-associated Kaposi's Sarcoma (KS)   Total 
Overall Participants Analyzed 
[Units: Participants]
 10   6   16 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      10 100.0%      6 100.0%      16 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Full Range)
 50.85 
 (24.8 to 57.1) 
 40.85 
 (32.0 to 57.9) 
 45.95 
 (24.8 to 57.9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      0   0.0%      0   0.0%      0   0.0% 
Male      10 100.0%      6 100.0%      16 100.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      3  30.0%      2  33.3%      5  31.3% 
Not Hispanic or Latino      7  70.0%      4  66.7%      11  68.8% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      4  40.0%      4  66.7%      8  50.0% 
White      4  40.0%      0   0.0%      4  25.0% 
More than one race      1  10.0%      1  16.7%      2  12.5% 
Unknown or Not Reported      1  10.0%      1  16.7%      2  12.5% 
Region of Enrollment 
[Units: Participants]
     
United States   10   6   16 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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 ]

2.  Secondary:   Complete Response Rate After 6 Cycles of Liposomal Doxorubicin Combined With Bevacizumab   [ Time Frame: 6 cycles, an average of 18 weeks ]

3.  Secondary:   Count of Participants With Serious and Non-serious Adverse Events   [ Time Frame: 7 years and 6 months and 21 days ]

4.  Secondary:   Median Number of Cycles Need to Obtain a Partial Response   [ Time Frame: 6 cycles, an average of 18 weeks ]

5.  Secondary:   Percentage of Participants With 12- Month Progression-free Survival (PFS)   [ Time Frame: 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Robert Yarchoan
Organization: National Cancer Institute
phone: 301-496-0328
e-mail: yarchoanr@pop.nci.nih.gov



Responsible Party: Robert Yarchoan, National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00923936     History of Changes
Obsolete Identifiers: NCT00902239
Other Study ID Numbers: 090130
09-C-0130
First Submitted: June 17, 2009
First Posted: June 18, 2009
Results First Submitted: April 14, 2017
Results First Posted: June 16, 2017
Last Update Posted: June 16, 2017