Trial Outcomes & Findings for Bevacizumab to Treat Kaposi's Sarcoma in HIV-Positive and HIV-Negative Patients (NCT NCT00055237)
NCT ID: NCT00055237
Last Updated: 2017-09-06
Results Overview
Percentage of participants with a complete response (CR) + partial response (PR)per the Modified AIDS Clinical Trial Group Criteria (ACTG) for HIV-KS. PR is a 50% decrease in the number and/or size of previously existing lesions for 4 weeks; or complete flattening of at least 50% of all previously raised lesions lasting for at least 4 weeks; or a 50% decrease in the sum of the products of the largest perpendicular diameters of the marker lesions lasting for at least 4 weeks; CR is the absence of any detectable residual disease, including tumor associated edema, persisting for at least 4 weeks.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
19 participants
Primary outcome timeframe
36 months
Results posted on
2017-09-06
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
2
|
|
Overall Study
COMPLETED
|
17
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bevacizumab to Treat Kaposi's Sarcoma in HIV-Positive and HIV-Negative Patients
Baseline characteristics by cohort
| Measure |
Cohort 1: Cohort 1: Pts With HIV-associated Kaposi's Sarcoma
n=17 Participants
15 mg/kg bevacizumab intravenously on days 1 and 8 then every 3 weeks
|
Cohort 2: Pts With Classic Kaposi's Sarcoma (HIV-uninfected)
n=2 Participants
15 mg/kg bevacizumab intravenously on days 1 and 8 then every 3 weeks
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
42 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
58 years
STANDARD_DEVIATION 12.7 • n=7 Participants
|
50 years
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
2 participants
n=7 Participants
|
19 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 36 monthsPopulation: Cohort 2 is not reported here because response rate in HIV negative patients was a secondary outcome.
Percentage of participants with a complete response (CR) + partial response (PR)per the Modified AIDS Clinical Trial Group Criteria (ACTG) for HIV-KS. PR is a 50% decrease in the number and/or size of previously existing lesions for 4 weeks; or complete flattening of at least 50% of all previously raised lesions lasting for at least 4 weeks; or a 50% decrease in the sum of the products of the largest perpendicular diameters of the marker lesions lasting for at least 4 weeks; CR is the absence of any detectable residual disease, including tumor associated edema, persisting for at least 4 weeks.
Outcome measures
| Measure |
Cohort 1: Cohort 1: Pts With HIV-associated Kaposi's Sarcoma
n=16 Participants
15 mg/kg bevacizumab intravenously on days 1 and 8 then every 3 weeks
|
|---|---|
|
Response Rate
|
31 Percentage of participants
Interval 11.0 to 58.7
|
SECONDARY outcome
Timeframe: 70 monthsPopulation: All adverse events regardless of attribution, over 202 cycles in 19 patients. Per protocol analysis of adverse events. Cohort 1 and 2 are reported together.
Here are the number of participants with adverse events. For the detailed list of adverse events, see the adverse event module.
Outcome measures
| Measure |
Cohort 1: Cohort 1: Pts With HIV-associated Kaposi's Sarcoma
n=19 Participants
15 mg/kg bevacizumab intravenously on days 1 and 8 then every 3 weeks
|
|---|---|
|
Number of Participants With Adverse Events
|
19 Participants
|
Adverse Events
Cohort 1 & 2: Pts With HIV-associated and Classic KS
Serious events: 4 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1 & 2: Pts With HIV-associated and Classic KS
n=19 participants at risk
15 mg/kg bevacizumab intravenously on days 1 and 8 then every 3 weeks
|
|---|---|
|
Metabolism and nutrition disorders
Acidosis (metabolic or respiratory)
|
5.3%
1/19 • Number of events 1 • 70 months
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome (ARDS)
|
5.3%
1/19 • Number of events 1 • 70 months
|
|
Investigations
Bicarbonate
|
5.3%
1/19 • Number of events 1 • 70 months
|
|
Investigations
CPK (creatine phosphokinase)
|
5.3%
1/19 • Number of events 1 • 70 months
|
|
Investigations
Creatinine
|
5.3%
1/19 • Number of events 1 • 70 months
|
|
Investigations
Hemoglobin
|
5.3%
1/19 • Number of events 3 • 70 months
|
|
Vascular disorders
Hypotension
|
5.3%
1/19 • Number of events 1 • 70 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.3%
1/19 • Number of events 1 • 70 months
|
|
Infections and infestations
Infection
|
5.3%
1/19 • Number of events 1 • 70 months
|
|
Infections and infestations
Infection/Febrile Neutropenia-Other (Specify, from leg cellulitis)
|
15.8%
3/19 • Number of events 3 • 70 months
|
|
Investigations
Partial thromboplastin time (PTT)
|
5.3%
1/19 • Number of events 1 • 70 months
|
|
Investigations
Platelets
|
5.3%
1/19 • Number of events 1 • 70 months
|
|
Renal and urinary disorders
Renal failure
|
5.3%
1/19 • Number of events 1 • 70 months
|
|
General disorders
Syndromes-Other (Specify, toxic shock syndrome)
|
5.3%
1/19 • Number of events 1 • 70 months
|
|
Blood and lymphatic system disorders
Transfusion: Platelets
|
5.3%
1/19 • Number of events 1 • 70 months
|
|
Gastrointestinal disorders
Vomit
|
5.3%
1/19 • Number of events 1 • 70 months
|
Other adverse events
| Measure |
Cohort 1 & 2: Pts With HIV-associated and Classic KS
n=19 participants at risk
15 mg/kg bevacizumab intravenously on days 1 and 8 then every 3 weeks
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain or cramping
|
5.3%
1/19 • Number of events 1 • 70 months
|
|
Investigations
Alkaline phosphatase
|
10.5%
2/19 • Number of events 8 • 70 months
|
|
Immune system disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
42.1%
8/19 • Number of events 10 • 70 months
|
|
Investigations
Amylase
|
47.4%
9/19 • Number of events 20 • 70 months
|
|
Gastrointestinal disorders
Anorexia
|
10.5%
2/19 • Number of events 2 • 70 months
|
|
Investigations
Bilirubin
|
57.9%
11/19 • Number of events 26 • 70 months
|
|
Investigations
CPK (creatine phosphokinase)
|
42.1%
8/19 • Number of events 27 • 70 months
|
|
Gastrointestinal disorders
Constipation
|
26.3%
5/19 • Number of events 6 • 70 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
47.4%
9/19 • Number of events 15 • 70 months
|
|
Investigations
Creatinine
|
15.8%
3/19 • Number of events 6 • 70 months
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin-Other (Specify, foot callous; burning sensation in abdominal area)
|
10.5%
2/19 • Number of events 2 • 70 months
|
|
Gastrointestinal disorders
Diarrhea patients without colostomy
|
47.4%
9/19 • Number of events 17 • 70 months
|
|
Nervous system disorders
Dizziness/lightheadedness
|
10.5%
2/19 • Number of events 2 • 70 months
|
|
Eye disorders
Dry eye
|
5.3%
1/19 • Number of events 1 • 70 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
5.3%
1/19 • Number of events 1 • 70 months
|
|
Renal and urinary disorders
Dysuria (painful urination)
|
5.3%
1/19 • Number of events 1 • 70 months
|
|
General disorders
Edema
|
15.8%
3/19 • Number of events 5 • 70 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
42.1%
8/19 • Number of events 12 • 70 months
|
|
General disorders
Fatigue (lethargy, malaise, asthenia)
|
26.3%
5/19 • Number of events 9 • 70 months
|
|
General disorders
Fever
|
47.4%
9/19 • Number of events 13 • 70 months
|
|
Gastrointestinal disorders
Gastrointestinal-Other (Specify, bloating fullness; slight indigestion)
|
10.5%
2/19 • Number of events 2 • 70 months
|
|
Nervous system disorders
Headache
|
57.9%
11/19 • Number of events 30 • 70 months
|
|
Renal and urinary disorders
Hematuria (in the absence of vaginal bleeding)
|
42.1%
8/19 • Number of events 10 • 70 months
|
|
Investigations
Hemoglobin
|
52.6%
10/19 • Number of events 31 • 70 months
|
|
Renal and urinary disorders
Hemoglobinuria
|
52.6%
10/19 • Number of events 23 • 70 months
|
|
Blood and lymphatic system disorders
Hemolysis (e.g., immune hemolytic anemia, drug related hemolysis, other)
|
5.3%
1/19 • Number of events 2 • 70 months
|
|
Blood and lymphatic system disorders
Hemorrhage-Other (Specify, gums; gums bleeding)
|
5.3%
1/19 • Number of events 2 • 70 months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
5.3%
1/19 • Number of events 1 • 70 months
|
|
Metabolism and nutrition disorders
Hypercholesterolemia
|
15.8%
3/19 • Number of events 4 • 70 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
42.1%
8/19 • Number of events 37 • 70 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
10.5%
2/19 • Number of events 2 • 70 months
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
21.1%
4/19 • Number of events 8 • 70 months
|
|
Vascular disorders
Hypertension
|
52.6%
10/19 • Number of events 18 • 70 months
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
15.8%
3/19 • Number of events 7 • 70 months
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
15.8%
3/19 • Number of events 10 • 70 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
68.4%
13/19 • Number of events 48 • 70 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
36.8%
7/19 • Number of events 25 • 70 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
26.3%
5/19 • Number of events 8 • 70 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
10.5%
2/19 • Number of events 9 • 70 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
42.1%
8/19 • Number of events 17 • 70 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
63.2%
12/19 • Number of events 46 • 70 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
42.1%
8/19 • Number of events 21 • 70 months
|
|
Endocrine disorders
Hypothyroidism
|
5.3%
1/19 • Number of events 1 • 70 months
|
|
Infections and infestations
Infection without neutropenia
|
15.8%
3/19 • Number of events 5 • 70 months
|
|
Infections and infestations
Infection/Febrile Neutropenia-Other (Specify)
|
10.5%
2/19 • Number of events 4 • 70 months
|
|
Psychiatric disorders
Insomnia
|
15.8%
3/19 • Number of events 4 • 70 months
|
|
Investigations
Leukocytes (total WBC)
|
42.1%
8/19 • Number of events 33 • 70 months
|
|
Investigations
Lipase
|
15.8%
3/19 • Number of events 7 • 70 months
|
|
Investigations
Lymphopenia
|
21.1%
4/19 • Number of events 11 • 70 months
|
|
Gastrointestinal disorders
Mouth dryness
|
5.3%
1/19 • Number of events 1 • 70 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal-Other (Specify, joint stiffness)
|
5.3%
1/19 • Number of events 1 • 70 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia (muscle pain)
|
26.3%
5/19 • Number of events 8 • 70 months
|
|
Gastrointestinal disorders
Nausea
|
31.6%
6/19 • Number of events 7 • 70 months
|
|
Nervous system disorders
Neuropathy-sensory
|
21.1%
4/19 • Number of events 6 • 70 months
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
68.4%
13/19 • Number of events 54 • 70 months
|
|
General disorders
Pain-Other (back pain;leg pain; heel pain; throat pain; from leg cellulitis; in R posterior knee)
|
52.6%
10/19 • Number of events 27 • 70 months
|
|
Cardiac disorders
Palpitations
|
5.3%
1/19 • Number of events 1 • 70 months
|
|
Investigations
Partial thromboplastin time (PTT)
|
52.6%
10/19 • Number of events 16 • 70 months
|
|
Skin and subcutaneous tissue disorders
Pigmentation changes (e.g., vitiligo)
|
5.3%
1/19 • Number of events 1 • 70 months
|
|
Blood and lymphatic system disorders
Platelets
|
57.9%
11/19 • Number of events 25 • 70 months
|
|
Renal and urinary disorders
Proteinuria
|
73.7%
14/19 • Number of events 56 • 70 months
|
|
Investigations
Prothrombin time (PT)
|
31.6%
6/19 • Number of events 10 • 70 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.5%
2/19 • Number of events 3 • 70 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary-Other (Specify, sneezing)
|
5.3%
1/19 • Number of events 1 • 70 months
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
21.1%
4/19 • Number of events 7 • 70 months
|
|
Gastrointestinal disorders
Rectal bleeding/hematochezia
|
5.3%
1/19 • Number of events 1 • 70 months
|
|
General disorders
Rigors, chills
|
10.5%
2/19 • Number of events 2 • 70 months
|
|
Investigations
SGOT (AST) (serum glutamic oxaloacetic transaminase)
|
68.4%
13/19 • Number of events 45 • 70 months
|
|
Investigations
SGPT (ALT) (serum glutamic pyruvic transaminase)
|
42.1%
8/19 • Number of events 22 • 70 months
|
|
Skin and subcutaneous tissue disorders
Sweating (diaphoresis)
|
26.3%
5/19 • Number of events 5 • 70 months
|
|
Nervous system disorders
Taste disturbance (dysgeusia)
|
10.5%
2/19 • Number of events 2 • 70 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain (onset or exacerbation of tumor pain due to treatment)
|
5.3%
1/19 • Number of events 1 • 70 months
|
|
Eye disorders
Vision-blurred vision
|
5.3%
1/19 • Number of events 1 • 70 months
|
|
Eye disorders
Vision-flashing lights/floaters
|
5.3%
1/19 • Number of events 1 • 70 months
|
|
Gastrointestinal disorders
Vomiting
|
31.6%
6/19 • Number of events 7 • 70 months
|
|
Investigations
Weight loss
|
10.5%
2/19 • Number of events 2 • 70 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia (joint pain)
|
21.1%
4/19 • Number of events 7 • 70 months
|
|
Cardiac disorders
Cardiac left ventricular function
|
5.3%
1/19 • Number of events 1 • 70 months
|
|
Cardiac disorders
Cardiac troponin I (cTnI)
|
5.3%
1/19 • Number of events 1 • 70 months
|
|
Investigations
CD4 count
|
5.3%
1/19 • Number of events 1 • 70 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.3%
1/19 • Number of events 1 • 70 months
|
|
Reproductive system and breast disorders
Gynecomastia
|
5.3%
1/19 • Number of events 1 • 70 months
|
|
Vascular disorders
Phlebitis (superficial)
|
5.3%
1/19 • Number of events 1 • 70 months
|
|
Vascular disorders
Thrombosis/embolism
|
5.3%
1/19 • Number of events 1 • 70 months
|
|
Reproductive system and breast disorders
Vaginal bleeding
|
5.3%
1/19 • Number of events 1 • 70 months
|
|
Ear and labyrinth disorders
Auditory/Hearing-Other (Specify, hearing loss)
|
5.3%
1/19 • Number of events 1 • 70 months
|
|
Psychiatric disorders
Confusion
|
5.3%
1/19 • Number of events 1 • 70 months
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
5.3%
1/19 • Number of events 1 • 70 months
|
|
Nervous system disorders
Neuropathy - cranial
|
5.3%
1/19 • Number of events 1 • 70 months
|
Additional Information
Robert Yarchoan, M.D.
National Cancer Institute, National Institutes of Health
Phone: 301-496-0328
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place