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Bevacizumab to Treat Kaposi's Sarcoma in HIV-Positive and HIV-Negative Patients

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00055237
First received: February 21, 2003
Last updated: July 30, 2012
Last verified: July 2012
Results First Received: June 19, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Kaposi's Sarcoma
HIV Infections
HIV Seronegativity
Intervention: Biological: Bevacizumab

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Cohort 1: Cohort 1: Pts With HIV-associated Kaposi's Sarcoma 15 mg/kg bevacizumab intravenously on days 1 and 8 then every 3 weeks
Cohort 2: Pts With Classic Kaposi's Sarcoma (HIV-uninfected) 15 mg/kg bevacizumab intravenously on days 1 and 8 then every 3 weeks

Participant Flow:   Overall Study
    Cohort 1: Cohort 1: Pts With HIV-associated Kaposi's Sarcoma   Cohort 2: Pts With Classic Kaposi's Sarcoma (HIV-uninfected)
STARTED   17   2 
COMPLETED   17   2 
NOT COMPLETED   0   0 



  Baseline Characteristics
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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.
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Reporting Groups
  Description
Cohort 1: Cohort 1: Pts With HIV-associated Kaposi's Sarcoma 15 mg/kg bevacizumab intravenously on days 1 and 8 then every 3 weeks
Cohort 2: Pts With Classic Kaposi's Sarcoma (HIV-uninfected) 15 mg/kg bevacizumab intravenously on days 1 and 8 then every 3 weeks
Total Total of all reporting groups

Baseline Measures
    Cohort 1: Cohort 1: Pts With HIV-associated Kaposi's Sarcoma   Cohort 2: Pts With Classic Kaposi's Sarcoma (HIV-uninfected)   Total
Overall Participants Analyzed 
[Units: Participants]
 17   2   19 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   15   2   17 
>=65 years   2   0   2 
Age 
[Units: Years]
Mean (Standard Deviation)
 42  (9.3)   58  (12.7)   50  (11) 
Gender 
[Units: Participants]
     
Female   1   0   1 
Male   16   2   18 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   3   0   3 
Not Hispanic or Latino   14   2   16 
Unknown or Not Reported   0   0   0 
Region of Enrollment 
[Units: Participants]
     
United States   17   2   19 


  Outcome Measures
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1.  Primary:   Response Rate   [ Time Frame: 36 months ]

2.  Secondary:   Number of Participants With Adverse Events   [ Time Frame: 70 months ]


  Serious Adverse Events


  Other Adverse Events
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Time Frame No text entered.
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Frequency Threshold
Threshold above which other adverse events are reported   0  

Reporting Groups
  Description
Cohort 1 & 2: Pts With HIV-associated and Classic KS 15 mg/kg bevacizumab intravenously on days 1 and 8 then every 3 weeks

Other Adverse Events
    Cohort 1 & 2: Pts With HIV-associated and Classic KS
Total, other (not including serious) adverse events   
# participants affected / at risk   19/19 (100.00%) 
Blood and lymphatic system disorders   
Hemolysis (e.g., immune hemolytic anemia, drug related hemolysis, other) † 1   
# participants affected / at risk   1/19 (5.26%) 
# events   2 
Hemorrhage-Other (Specify, gums; gums bleeding) † 1   
# participants affected / at risk   1/19 (5.26%) 
# events   2 
Platelets † 1   
# participants affected / at risk   11/19 (57.89%) 
# events   25 
Cardiac disorders   
Palpitations † 1   
# participants affected / at risk   1/19 (5.26%) 
# events   1 
Cardiac left ventricular function † 1   
# participants affected / at risk   1/19 (5.26%) 
# events   1 
Cardiac troponin I (cTnI) † 1   
# participants affected / at risk   1/19 (5.26%) 
# events   1 
Ear and labyrinth disorders   
Auditory/Hearing-Other (Specify, hearing loss) † 1   
# participants affected / at risk   1/19 (5.26%) 
# events   1 
Endocrine disorders   
Hypothyroidism † 1   
# participants affected / at risk   1/19 (5.26%) 
# events   1 
Eye disorders   
Dry eye † 1   
# participants affected / at risk   1/19 (5.26%) 
# events   1 
Vision-blurred vision † 1   
# participants affected / at risk   1/19 (5.26%) 
# events   1 
Vision-flashing lights/floaters † 1   
# participants affected / at risk   1/19 (5.26%) 
# events   1 
Gastrointestinal disorders   
Abdominal pain or cramping † 1   
# participants affected / at risk   1/19 (5.26%) 
# events   1 
Anorexia † 1   
# participants affected / at risk   2/19 (10.53%) 
# events   2 
Constipation † 1   
# participants affected / at risk   5/19 (26.32%) 
# events   6 
Diarrhea patients without colostomy † 1   
# participants affected / at risk   9/19 (47.37%) 
# events   17 
Gastrointestinal-Other (Specify, bloating fullness; slight indigestion) † 1   
# participants affected / at risk   2/19 (10.53%) 
# events   2 
Mouth dryness † 1   
# participants affected / at risk   1/19 (5.26%) 
# events   1 
Nausea † 1   
# participants affected / at risk   6/19 (31.58%) 
# events   7 
Rectal bleeding/hematochezia † 1   
# participants affected / at risk   1/19 (5.26%) 
# events   1 
Vomiting † 1   
# participants affected / at risk   6/19 (31.58%) 
# events   7 
General disorders   
Edema † 1   
# participants affected / at risk   3/19 (15.79%) 
# events   5 
Fatigue (lethargy, malaise, asthenia) † 1   
# participants affected / at risk   5/19 (26.32%) 
# events   9 
Fever † 1 [3]   
# participants affected / at risk   9/19 (47.37%) 
# events   13 
Pain-Other (back pain;leg pain; heel pain; throat pain; from leg cellulitis; in R posterior knee) † 1 [4]   
# participants affected / at risk   10/19 (52.63%) 
# events   27 
Rigors, chills † 1   
# participants affected / at risk   2/19 (10.53%) 
# events   2 
Immune system disorders   
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) † 1   
# participants affected / at risk   8/19 (42.11%) 
# events   10 
Infections and infestations   
Infection without neutropenia † 1   
# participants affected / at risk   3/19 (15.79%) 
# events   5 
Infection/Febrile Neutropenia-Other (Specify) † 1 [5]   
# participants affected / at risk   2/19 (10.53%) 
# events   4 
Investigations   
Alkaline phosphatase † 1   
# participants affected / at risk   2/19 (10.53%) 
# events   8 
Amylase † 1   
# participants affected / at risk   9/19 (47.37%) 
# events   20 
Bilirubin † 1   
# participants affected / at risk   11/19 (57.89%) 
# events   26 
CPK (creatine phosphokinase) † 1   
# participants affected / at risk   8/19 (42.11%) 
# events   27 
Creatinine † 1   
# participants affected / at risk   3/19 (15.79%) 
# events   6 
Hemoglobin † 1   
# participants affected / at risk   10/19 (52.63%) 
# events   31 
Leukocytes (total WBC) † 1   
# participants affected / at risk   8/19 (42.11%) 
# events   33 
Lipase † 1   
# participants affected / at risk   3/19 (15.79%) 
# events   7 
Lymphopenia † 1   
# participants affected / at risk   4/19 (21.05%) 
# events   11 
Neutrophils/granulocytes (ANC/AGC) † 1 [6]   
# participants affected / at risk   1/19 (5.26%) 
# events   1 
Partial thromboplastin time (PTT) † 1   
# participants affected / at risk   10/19 (52.63%) 
# events   16 
Prothrombin time (PT) † 1   
# participants affected / at risk   6/19 (31.58%) 
# events   10 
SGOT (AST) (serum glutamic oxaloacetic transaminase) † 1   
# participants affected / at risk   13/19 (68.42%) 
# events   45 
SGPT (ALT) (serum glutamic pyruvic transaminase) † 1   
# participants affected / at risk   8/19 (42.11%) 
# events   22 
Weight loss † 1   
# participants affected / at risk   2/19 (10.53%) 
# events   2 
CD4 count † 1   
# participants affected / at risk   1/19 (5.26%) 
# events   1 
Neutrophils/granulocytes (ANC/AGC) † 1 [7]   
# participants affected / at risk   13/19 (68.42%) 
# events   54 
Metabolism and nutrition disorders   
Hypercalcemia † 1   
# participants affected / at risk   1/19 (5.26%) 
# events   1 
Hypercholesterolemia † 1   
# participants affected / at risk   3/19 (15.79%) 
# events   4 
Hyperglycemia † 1   
# participants affected / at risk   8/19 (42.11%) 
# events   37 
Hyperkalemia † 1   
# participants affected / at risk   2/19 (10.53%) 
# events   2 
Hypermagnesemia † 1   
# participants affected / at risk   4/19 (21.05%) 
# events   8 
Hypertriglyceridemia † 1   
# participants affected / at risk   3/19 (15.79%) 
# events   7 
Hyperuricemia † 1   
# participants affected / at risk   3/19 (15.79%) 
# events   10 
Hypoalbuminemia † 1   
# participants affected / at risk   13/19 (68.42%) 
# events   48 
Hypocalcemia † 1   
# participants affected / at risk   7/19 (36.84%) 
# events   25 
Hypoglycemia † 1   
# participants affected / at risk   5/19 (26.32%) 
# events   8 
Hypokalemia † 1   
# participants affected / at risk   2/19 (10.53%) 
# events   9 
Hypomagnesemia † 1   
# participants affected / at risk   8/19 (42.11%) 
# events   17 
Hyponatremia † 1   
# participants affected / at risk   12/19 (63.16%) 
# events   46 
Hypophosphatemia † 1   
# participants affected / at risk   8/19 (42.11%) 
# events   21 
Musculoskeletal and connective tissue disorders   
Musculoskeletal-Other (Specify, joint stiffness) † 1   
# participants affected / at risk   1/19 (5.26%) 
# events   1 
Myalgia (muscle pain) † 1   
# participants affected / at risk   5/19 (26.32%) 
# events   8 
Arthralgia (joint pain) † 1   
# participants affected / at risk   4/19 (21.05%) 
# events   7 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Tumor pain (onset or exacerbation of tumor pain due to treatment) † 1   
# participants affected / at risk   1/19 (5.26%) 
# events   1 
Nervous system disorders   
Dizziness/lightheadedness † 1   
# participants affected / at risk   2/19 (10.53%) 
# events   2 
Headache † 1   
# participants affected / at risk   11/19 (57.89%) 
# events   30 
Neuropathy-sensory † 1   
# participants affected / at risk   4/19 (21.05%) 
# events   6 
Taste disturbance (dysgeusia) † 1   
# participants affected / at risk   2/19 (10.53%) 
# events   2 
Neuropathy - cranial † 1   
# participants affected / at risk   1/19 (5.26%) 
# events   1 
Psychiatric disorders   
Insomnia † 1   
# participants affected / at risk   3/19 (15.79%) 
# events   4 
Confusion † 1   
# participants affected / at risk   1/19 (5.26%) 
# events   1 
Renal and urinary disorders   
Dysuria (painful urination) † 1   
# participants affected / at risk   1/19 (5.26%) 
# events   1 
Hematuria (in the absence of vaginal bleeding) † 1   
# participants affected / at risk   8/19 (42.11%) 
# events   10 
Hemoglobinuria † 1   
# participants affected / at risk   10/19 (52.63%) 
# events   23 
Proteinuria † 1   
# participants affected / at risk   14/19 (73.68%) 
# events   56 
Reproductive system and breast disorders   
Gynecomastia † 1   
# participants affected / at risk   1/19 (5.26%) 
# events   1 
Vaginal bleeding † 1   
# participants affected / at risk   1/19 (5.26%) 
# events   1 
Respiratory, thoracic and mediastinal disorders   
Cough † 1   
# participants affected / at risk   9/19 (47.37%) 
# events   15 
Dyspnea (shortness of breath) † 1   
# participants affected / at risk   1/19 (5.26%) 
# events   1 
Epistaxis † 1   
# participants affected / at risk   8/19 (42.11%) 
# events   12 
Pulmonary-Other (Specify, sneezing) † 1   
# participants affected / at risk   1/19 (5.26%) 
# events   1 
Skin and subcutaneous tissue disorders   
Dermatology/Skin-Other (Specify, foot callous; burning sensation in abdominal area) † 1   
# participants affected / at risk   2/19 (10.53%) 
# events   2 
Pigmentation changes (e.g., vitiligo) † 1   
# participants affected / at risk   1/19 (5.26%) 
# events   1 
Pruritus † 1   
# participants affected / at risk   2/19 (10.53%) 
# events   3 
Rash/desquamation † 1   
# participants affected / at risk   4/19 (21.05%) 
# events   7 
Sweating (diaphoresis) † 1   
# participants affected / at risk   5/19 (26.32%) 
# events   5 
Dry skin † 1   
# participants affected / at risk   1/19 (5.26%) 
# events   1 
Nail changes † 1   
# participants affected / at risk   1/19 (5.26%) 
# events   1 
Vascular disorders   
Hypertension † 1   
# participants affected / at risk   10/19 (52.63%) 
# events   18 
Phlebitis (superficial) † 1   
# participants affected / at risk   1/19 (5.26%) 
# events   1 
Thrombosis/embolism † 1   
# participants affected / at risk   1/19 (5.26%) 
# events   1 
Events were collected by systematic assessment
1 Term from vocabulary, CTCv2.0
[3] (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 10e9/L)
[4] continued plantar fascilitis;jaw pain;knee pain;local pain foot/leg;pressure R mid back;sore throat;tooth pain;burn L thumb;chest pain;cramps in feet;soreness L index finger;knee-tumor pain;leg pain;side mandibular LN tender; infection,abcess tooth
[5] fungal infections, feet tinea pedis; URI; swelling behind R knee; tinea L axilla
[6] for leukemia studies or bone marrow infiltrative/myelophthisic process, if specified in the protocol.
[7] Neutrophils/granulocytes (ANC/AGC) for leukemia studies or bone marrow infiltrative/myelophthisic process, if specified in the protocol.



  Limitations and Caveats
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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
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