Trial Outcomes & Findings for Bevacizumab (Avastin) and RAD001(Everolimus)in the Treatment of Advanced Clear Cell Renal Carcinoma (NCT NCT00323739)
NCT ID: NCT00323739
Last Updated: 2013-07-26
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
80 participants
Primary outcome timeframe
18 months
Results posted on
2013-07-26
Participant Flow
Eighty-four patients with advanced kidney cancer were assessed for participation at multiple US clinics between August 2006 and November 2008.
Four patients did not meet eligibility criteria and were not treated.
Participant milestones
| Measure |
Bevacizumab and Everolimus
Patients received 10mg/kg of bevacizumab by IV infusion on day 1 and day 15 of each 28-day treatment cycle. Patients took 1 10mg tablet of everolimus every day for 28 days. Treatment continued until evidence of their disease worsening was found or until the side effects of treatment became intolerable to the patient. The treating physician could also stop treatment if the patient's safety was felt to be at risk.
|
|---|---|
|
Overall Study
STARTED
|
80
|
|
Overall Study
COMPLETED
|
80
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bevacizumab (Avastin) and RAD001(Everolimus)in the Treatment of Advanced Clear Cell Renal Carcinoma
Baseline characteristics by cohort
| Measure |
Bevacizumab and Everolimus
n=80 Participants
Patients received 10mg/kg of bevacizumab by IV infusion on day 1 and day 15 of each 28-day treatment cycle. Patients took 1 10mg tablet of everolimus every day for 28 days. Treatment continued until evidence of their disease worsening was found or until the side effects of treatment became intolerable to the patient. The treating physician could also stop treatment if the patient's safety was felt to be at risk.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
42 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
38 Participants
n=5 Participants
|
|
Age Continuous
|
64 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
60 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
80 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 18 monthsOutcome measures
| Measure |
Bevacizumab and Everolimus
n=80 Participants
Patients received 10mg/kg of bevacizumab by IV infusion on day 1 and day 15 of each 28-day treatment cycle. Patients took 1 10mg tablet of everolimus every day for 28 days. Treatment continued until evidence of their disease worsening was found or until the side effects of treatment became intolerable to the patient. The treating physician could also stop treatment if the patient's safety was felt to be at risk.
|
|---|---|
|
Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease
|
8.1 Months
Interval 6.3 to 10.8
|
SECONDARY outcome
Timeframe: 18 monthsOutcome measures
| Measure |
Bevacizumab and Everolimus
n=80 Participants
Patients received 10mg/kg of bevacizumab by IV infusion on day 1 and day 15 of each 28-day treatment cycle. Patients took 1 10mg tablet of everolimus every day for 28 days. Treatment continued until evidence of their disease worsening was found or until the side effects of treatment became intolerable to the patient. The treating physician could also stop treatment if the patient's safety was felt to be at risk.
|
|---|---|
|
Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death
|
18.5 Months
Interval 14.52 to
Patients remained on treatment at the time statistical analyses were conducted.
|
Adverse Events
Bevacizumab + Everolimus
Serious events: 25 serious events
Other events: 62 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bevacizumab + Everolimus
n=80 participants at risk
|
|---|---|
|
Cardiac disorders
Ventricular arrhythmia - left ventricular dysfunction
|
1.2%
1/80 • Number of events 1
|
|
Psychiatric disorders
Mood alteration - depression
|
1.2%
1/80 • Number of events 1
|
|
Vascular disorders
Thrombus/thrombosis/embolism - lung
|
1.2%
1/80 • Number of events 1
|
|
Renal and urinary disorders
Nephrotic syndrome
|
2.5%
2/80 • Number of events 2
|
|
Cardiac disorders
Cardiac ischemia/infarction
|
2.5%
2/80 • Number of events 2
|
|
Gastrointestinal disorders
Inflammation - small bowel
|
1.2%
1/80 • Number of events 1
|
|
Gastrointestinal disorders
Diverticulitis
|
1.2%
1/80 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fracture - right hip
|
1.2%
1/80 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
2.5%
2/80 • Number of events 2
|
|
Gastrointestinal disorders
Obstruction - small bowel
|
1.2%
1/80 • Number of events 1
|
|
Nervous system disorders
Altered mental status
|
1.2%
1/80 • Number of events 1
|
|
Gastrointestinal disorders
Anorexia
|
1.2%
1/80 • Number of events 1
|
|
Gastrointestinal disorders
Obstruction - bowel
|
1.2%
1/80 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Disease progression
|
7.5%
6/80 • Number of events 6
|
|
Infections and infestations
Infection - pneumonia
|
2.5%
2/80 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Abcess - lung
|
1.2%
1/80 • Number of events 1
|
|
Nervous system disorders
Encephalopathy
|
1.2%
1/80 • Number of events 1
|
|
Nervous system disorders
Syncope
|
1.2%
1/80 • Number of events 1
|
|
Blood and lymphatic system disorders
Anemia
|
1.2%
1/80 • Number of events 1
|
|
Hepatobiliary disorders
Cholelithiasis
|
2.5%
2/80 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis (non-infectious)
|
1.2%
1/80 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fracture
|
1.2%
1/80 • Number of events 1
|
|
Infections and infestations
Infection, not otherwise specified
|
1.2%
1/80 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Parapneumonic effusion
|
1.2%
1/80 • Number of events 2
|
|
General disorders
Pain - abdomen
|
1.2%
1/80 • Number of events 1
|
|
Renal and urinary disorders
Proteinuria
|
1.2%
1/80 • Number of events 1
|
|
Injury, poisoning and procedural complications
Injury - compression of right mainstem bronchus
|
1.2%
1/80 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.2%
1/80 • Number of events 1
|
|
Infections and infestations
Infection - urosepsis
|
1.2%
1/80 • Number of events 1
|
|
Gastrointestinal disorders
Perforation - rectum
|
1.2%
1/80 • Number of events 1
|
|
Renal and urinary disorders
Renal failure
|
2.5%
2/80 • Number of events 2
|
|
Gastrointestinal disorders
Hemmorhage - rectum
|
1.2%
1/80 • Number of events 1
|
|
Hepatobiliary disorders
Cholecystitis
|
1.2%
1/80 • Number of events 1
|
|
Nervous system disorders
Neuropathy
|
1.2%
1/80 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
1.2%
1/80 • Number of events 2
|
|
General disorders
Weakness
|
1.2%
1/80 • Number of events 1
|
Other adverse events
| Measure |
Bevacizumab + Everolimus
n=80 participants at risk
|
|---|---|
|
Metabolism and nutrition disorders
Alk Phosphate
|
21.2%
17/80 • Number of events 32
|
|
Gastrointestinal disorders
Anorexia
|
33.8%
27/80 • Number of events 94
|
|
Metabolism and nutrition disorders
AST,SGOT
|
13.8%
11/80 • Number of events 24
|
|
General disorders
Asthenia
|
7.5%
6/80 • Number of events 11
|
|
General disorders
Chills
|
8.8%
7/80 • Number of events 8
|
|
Gastrointestinal disorders
Constipation
|
23.8%
19/80 • Number of events 47
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
30.0%
24/80 • Number of events 54
|
|
Metabolism and nutrition disorders
Creatinine
|
32.5%
26/80 • Number of events 166
|
|
Gastrointestinal disorders
Dehydration
|
16.2%
13/80 • Number of events 15
|
|
Gastrointestinal disorders
Diarrhea
|
43.8%
35/80 • Number of events 98
|
|
Nervous system disorders
Dizziness
|
10.0%
8/80 • Number of events 13
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
15.0%
12/80 • Number of events 25
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
26.2%
21/80 • Number of events 125
|
|
Blood and lymphatic system disorders
Edema
|
22.5%
18/80 • Number of events 58
|
|
Blood and lymphatic system disorders
Edema (limb)
|
17.5%
14/80 • Number of events 45
|
|
General disorders
Fatigue
|
77.5%
62/80 • Number of events 359
|
|
General disorders
Fever
|
15.0%
12/80 • Number of events 22
|
|
Renal and urinary disorders
Hematuria
|
5.0%
4/80 • Number of events 41
|
|
Blood and lymphatic system disorders
Hemoglobin
|
63.7%
51/80 • Number of events 444
|
|
Vascular disorders
Hemorrhage (nose)
|
31.2%
25/80 • Number of events 107
|
|
Gastrointestinal disorders
Hemorrhoids
|
7.5%
6/80 • Number of events 16
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
8.8%
7/80 • Number of events 10
|
|
Metabolism and nutrition disorders
Hypercholesterolemia
|
41.2%
33/80 • Number of events 162
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
30.0%
24/80 • Number of events 76
|
|
Metabolism and nutrition disorders
Hyperlipidemia
|
5.0%
4/80 • Number of events 8
|
|
Cardiac disorders
Hypertension
|
42.5%
34/80 • Number of events 143
|
|
Metabolism and nutrition disorders
Hypoalubminemia
|
7.5%
6/80 • Number of events 16
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
10.0%
8/80 • Number of events 21
|
|
Metabolism and nutrition disorders
Hypokakalemia
|
8.8%
7/80 • Number of events 14
|
|
Metabolism and nutrition disorders
Hyponatremia
|
7.5%
6/80 • Number of events 22
|
|
Infections and infestations
Infection (NOS)
|
6.2%
5/80 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Infection (sinus)
|
6.2%
5/80 • Number of events 24
|
|
Respiratory, thoracic and mediastinal disorders
Infection (URI)
|
11.2%
9/80 • Number of events 15
|
|
Renal and urinary disorders
Infection (UTI)
|
11.2%
9/80 • Number of events 12
|
|
Blood and lymphatic system disorders
Leukocytes (WBC)
|
26.2%
21/80 • Number of events 142
|
|
Nervous system disorders
Mental Status Change
|
5.0%
4/80 • Number of events 5
|
|
Nervous system disorders
Mood alteration (anxiety)
|
8.8%
7/80 • Number of events 27
|
|
Nervous system disorders
Mood alteration (depression)
|
15.0%
12/80 • Number of events 81
|
|
Gastrointestinal disorders
Mucositis
|
43.8%
35/80 • Number of events 102
|
|
Skin and subcutaneous tissue disorders
Nail Changes
|
5.0%
4/80 • Number of events 12
|
|
Gastrointestinal disorders
Nausea
|
41.2%
33/80 • Number of events 92
|
|
Nervous system disorders
Neuropathy
|
5.0%
4/80 • Number of events 9
|
|
Nervous system disorders
Neuropathy (sensory)
|
7.5%
6/80 • Number of events 14
|
|
Blood and lymphatic system disorders
Neutrophils (ANC)
|
16.2%
13/80 • Number of events 55
|
|
Gastrointestinal disorders
Pain (abdominal)
|
10.0%
8/80 • Number of events 14
|
|
Musculoskeletal and connective tissue disorders
Pain (back)
|
15.0%
12/80 • Number of events 64
|
|
Musculoskeletal and connective tissue disorders
Pain (bone)
|
7.5%
6/80 • Number of events 10
|
|
Cardiac disorders
Pain (chest)
|
18.8%
15/80 • Number of events 38
|
|
Nervous system disorders
Pain (headache)
|
31.2%
25/80 • Number of events 82
|
|
Musculoskeletal and connective tissue disorders
Pain (jaw)
|
5.0%
4/80 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Pain (joint)
|
12.5%
10/80 • Number of events 60
|
|
Musculoskeletal and connective tissue disorders
Pain (limb)
|
26.2%
21/80 • Number of events 107
|
|
Musculoskeletal and connective tissue disorders
Pain (myalgia)
|
13.8%
11/80 • Number of events 34
|
|
Musculoskeletal and connective tissue disorders
Pain (neck)
|
8.8%
7/80 • Number of events 19
|
|
General disorders
Pain (NOS)
|
20.0%
16/80 • Number of events 41
|
|
Gastrointestinal disorders
Pain (oral)
|
5.0%
4/80 • Number of events 4
|
|
Gastrointestinal disorders
Pain (throat)
|
11.2%
9/80 • Number of events 19
|
|
Metabolism and nutrition disorders
Phosphorous
|
7.5%
6/80 • Number of events 8
|
|
Blood and lymphatic system disorders
Platelets
|
40.0%
32/80 • Number of events 225
|
|
Metabolism and nutrition disorders
Proteinuria
|
45.0%
36/80 • Number of events 243
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
20.0%
16/80 • Number of events 55
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
46.2%
37/80 • Number of events 122
|
|
Gastrointestinal disorders
Reflux
|
7.5%
6/80 • Number of events 81
|
|
Skin and subcutaneous tissue disorders
Skin (erythema)
|
12.5%
10/80 • Number of events 51
|
|
Skin and subcutaneous tissue disorders
Skin (lesion)
|
6.2%
5/80 • Number of events 20
|
|
Gastrointestinal disorders
Sore (mouth)
|
5.0%
4/80 • Number of events 6
|
|
Gastrointestinal disorders
Stomatitis
|
17.5%
14/80 • Number of events 26
|
|
Cardiac disorders
Tachycardia
|
5.0%
4/80 • Number of events 9
|
|
Gastrointestinal disorders
Taste Alteration
|
15.0%
12/80 • Number of events 35
|
|
Metabolism and nutrition disorders
Triglycerides
|
40.0%
32/80 • Number of events 190
|
|
Metabolism and nutrition disorders
Uric acid
|
11.2%
9/80 • Number of events 32
|
|
Respiratory, thoracic and mediastinal disorders
Voice change
|
10.0%
8/80 • Number of events 41
|
|
Gastrointestinal disorders
Vomiting
|
17.5%
14/80 • Number of events 37
|
|
General disorders
Weakness
|
18.8%
15/80 • Number of events 32
|
|
General disorders
Weight Loss
|
16.2%
13/80 • Number of events 41
|
|
Respiratory, thoracic and mediastinal disorders
Infection (pneumonia)
|
5.0%
4/80 • Number of events 7
|
|
General disorders
Insomnia
|
17.5%
14/80 • Number of events 28
|
Additional Information
John D. Hainsworth, MD
Sarah Cannon Research Institute
Phone: 1-877-691-7274
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor can review/embargo results communications prior to public release for a period that is \>60 days but ≤180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites.
- Publication restrictions are in place
Restriction type: OTHER