Trial Outcomes & Findings for Neoadjuvant Clinical Trial to Evaluate the Efficacy of Bevacizumab for Renal Cell Carcinoma (NCT NCT00113217)
NCT ID: NCT00113217
Last Updated: 2020-09-23
Results Overview
Time to progression calculated from the start of the study drug to the first evidence of disease progression. Time to progression reported as PFS measured in months. Progression (or progressive disease) defined by Response Evaluation Criteria in Solid Tumors (RECIST) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
COMPLETED
PHASE2
52 participants
Up to 3 years (or until disease progression)
2020-09-23
Participant Flow
Recruitment Period: February 22, 2005 to April 4, 2008. All participants were recruited at The University of Texas (UT) MD Anderson Cancer Center.
Of the fifty-two (52), two enrolled participants did not receive treatment and were excluded from the trial.
Participant milestones
| Measure |
Bevacizumab
10 mg/kg intravenous (IV) Day 1 of 14-day cycle.
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Neoadjuvant Clinical Trial to Evaluate the Efficacy of Bevacizumab for Renal Cell Carcinoma
Baseline characteristics by cohort
| Measure |
Bevacizumab
n=50 Participants
10 mg/kg intravenous (IV) Day 1 of 14-day cycle.
|
|---|---|
|
Age, Continuous
|
61 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 3 years (or until disease progression)Time to progression calculated from the start of the study drug to the first evidence of disease progression. Time to progression reported as PFS measured in months. Progression (or progressive disease) defined by Response Evaluation Criteria in Solid Tumors (RECIST) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Bevacizumab
n=50 Participants
10 mg/kg intravenous (IV) Day 1 of 14-day cycle.
|
|---|---|
|
Progression Free Survival (PFS)
|
11 months
Interval 5.5 to 15.6
|
SECONDARY outcome
Timeframe: Following 56 days treatmentSafety measured by participant toxicities in therapy with bevacizumab for Renal Cell Carcinoma (RCC).
Outcome measures
Outcome data not reported
Adverse Events
Bevacizumab
Serious adverse events
| Measure |
Bevacizumab
n=50 participants at risk
10 mg/kg intravenous (IV) Day 1 of 14-day cycle.
|
|---|---|
|
Blood and lymphatic system disorders
Hypertension
|
16.0%
8/50 • 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
12.0%
6/50 • 3 years
|
|
Blood and lymphatic system disorders
Anemia
|
10.0%
5/50 • 3 years
|
|
General disorders
Fatigue
|
12.0%
6/50 • 3 years
|
|
Blood and lymphatic system disorders
Hyperglycemia
|
6.0%
3/50 • 3 years
|
|
Blood and lymphatic system disorders
Elevated creatinine
|
8.0%
4/50 • 3 years
|
|
Gastrointestinal disorders
Abdominal pain
|
6.0%
3/50 • 3 years
|
|
Blood and lymphatic system disorders
Hypoalbuminemia
|
6.0%
3/50 • 3 years
|
|
Gastrointestinal disorders
Nausea
|
6.0%
3/50 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.0%
2/50 • 3 years
|
|
Gastrointestinal disorders
Vomiting
|
6.0%
3/50 • 3 years
|
|
Immune system disorders
Allergic reaction
|
4.0%
2/50 • 3 years
|
|
Gastrointestinal disorders
Anorexia
|
4.0%
2/50 • 3 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.0%
3/50 • 3 years
|
|
Blood and lymphatic system disorders
Thrombus/embolus
|
6.0%
3/50 • 3 years
|
|
Skin and subcutaneous tissue disorders
Wound healing delay/dehiscence
|
4.0%
2/50 • 3 years
|
|
Blood and lymphatic system disorders
Hyperbilirubinemia
|
2.0%
1/50 • 3 years
|
|
Metabolism and nutrition disorders
Dehydration
|
4.0%
2/50 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.0%
2/50 • 3 years
|
|
Blood and lymphatic system disorders
Hemorrhage
|
4.0%
2/50 • 3 years
|
|
Blood and lymphatic system disorders
Hypotension
|
2.0%
1/50 • 3 years
|
|
Infections and infestations
Appendicitis
|
2.0%
1/50 • 3 years
|
|
Nervous system disorders
Neuropathy
|
2.0%
1/50 • 3 years
|
|
Gastrointestinal disorders
Diverticulitis
|
2.0%
1/50 • 3 years
|
|
Infections and infestations
Pancreatitis
|
2.0%
1/50 • 3 years
|
|
Blood and lymphatic system disorders
Hypophosphatemia
|
0.00%
0/50 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.0%
1/50 • 3 years
|
|
Blood and lymphatic system disorders
Hypokalemia
|
2.0%
1/50 • 3 years
|
|
Renal and urinary disorders
Proteinuria
|
2.0%
1/50 • 3 years
|
|
Cardiac disorders
Supraventricular arrhythmia
|
2.0%
1/50 • 3 years
|
|
Blood and lymphatic system disorders
Hyperuricemia
|
6.0%
3/50 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Dysarthria
|
2.0%
1/50 • 3 years
|
|
General disorders
Weight gain
|
2.0%
1/50 • 3 years
|
|
General disorders
Death not associated with study drug
|
6.0%
3/50 • 3 years
|
Other adverse events
| Measure |
Bevacizumab
n=50 participants at risk
10 mg/kg intravenous (IV) Day 1 of 14-day cycle.
|
|---|---|
|
Blood and lymphatic system disorders
Hypertension
|
76.0%
38/50 • 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
66.0%
33/50 • 3 years
|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
50/50 • 3 years
|
|
General disorders
Fatigue
|
100.0%
50/50 • 3 years
|
|
Blood and lymphatic system disorders
Hyperglycemia
|
100.0%
50/50 • 3 years
|
|
Blood and lymphatic system disorders
Elevated creatinine
|
60.0%
30/50 • 3 years
|
|
Gastrointestinal disorders
Abdominal pain
|
32.0%
16/50 • 3 years
|
|
Blood and lymphatic system disorders
Hypoalbuminemia
|
42.0%
21/50 • 3 years
|
|
Gastrointestinal disorders
Nausea
|
68.0%
34/50 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
56.0%
28/50 • 3 years
|
|
Gastrointestinal disorders
Vomiting
|
44.0%
22/50 • 3 years
|
|
Gastrointestinal disorders
Anorexia
|
22.0%
11/50 • 3 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
96.0%
48/50 • 3 years
|
|
Skin and subcutaneous tissue disorders
Wound healing delay/dehiscence
|
20.0%
10/50 • 3 years
|
|
Blood and lymphatic system disorders
Hyperbilirubinemia
|
24.0%
12/50 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
24.0%
12/50 • 3 years
|
|
Blood and lymphatic system disorders
Hemorrhage
|
42.0%
21/50 • 3 years
|
|
Nervous system disorders
Neuropathy
|
6.0%
3/50 • 3 years
|
|
Blood and lymphatic system disorders
Proteinuria
|
66.0%
33/50 • 3 years
|
|
Blood and lymphatic system disorders
Hyperuricemia
|
38.0%
19/50 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Dysarthria
|
12.0%
6/50 • 3 years
|
|
General disorders
Weight gain
|
6.0%
3/50 • 3 years
|
Additional Information
Eric Jonasch, MD / Associate Professor
University of Texas (UT) MD Anderson Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place