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Trial Outcomes & Findings for Bevacizumab in Treating Patients With Relapsed Prostate Cancer That Did Not Respond to Hormone Therapy (NCT NCT01656304)

NCT ID: NCT01656304

Last Updated: 2018-07-31

Results Overview

A PSA response will be considered a PSA decline of at least 50% must be confirmed by a second PSA value four or more weeks later. The reference PSA for these declines should be a PSA measured within 2 weeks prior to the initiation of therapy. Response rates will be summarized by point estimates and Wilson type 80% confidence intervals.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

16 participants

Primary outcome timeframe

An average every 6 weeks for up to 3 months

Results posted on

2018-07-31

Participant Flow

Participant milestones

Participant milestones
Measure
Treatment (Monoclonal Antibody, Antiangiogenesis)
Patients receive bevacizumab IV over 30-90 minutes once every 14 days. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity. bevacizumab: Given IV laboratory biomarker analysis: Correlative studies
Overall Study
STARTED
16
Overall Study
COMPLETED
15
Overall Study
NOT COMPLETED
1

Reasons for withdrawal

Reasons for withdrawal
Measure
Treatment (Monoclonal Antibody, Antiangiogenesis)
Patients receive bevacizumab IV over 30-90 minutes once every 14 days. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity. bevacizumab: Given IV laboratory biomarker analysis: Correlative studies
Overall Study
Ineligible, uncontrolled hypertension
1

Baseline Characteristics

Bevacizumab in Treating Patients With Relapsed Prostate Cancer That Did Not Respond to Hormone Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Treatment (Monoclonal Antibody, Antiangiogenesis)
n=15 Participants
Patients receive bevacizumab IV over 30-90 minutes once every 14 days. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity. bevacizumab: Given IV laboratory biomarker analysis: Correlative studies
Age, Continuous
70.53 years
STANDARD_DEVIATION 10.38 • n=5 Participants
Sex: Female, Male
Female
0 Participants
n=5 Participants
Sex: Female, Male
Male
15 Participants
n=5 Participants
Region of Enrollment
United States
15 participants
n=5 Participants

PRIMARY outcome

Timeframe: An average every 6 weeks for up to 3 months

A PSA response will be considered a PSA decline of at least 50% must be confirmed by a second PSA value four or more weeks later. The reference PSA for these declines should be a PSA measured within 2 weeks prior to the initiation of therapy. Response rates will be summarized by point estimates and Wilson type 80% confidence intervals.

Outcome measures

Outcome measures
Measure
Treatment (Monoclonal Antibody, Antiangiogenesis)
n=15 Participants
Patients receive bevacizumab IV over 30-90 minutes once every 14 days. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity. bevacizumab: Given IV laboratory biomarker analysis: Correlative studies
PSA Response Rate With Bevacizumab Therapy in Androgen Independent Non-metastatic Prostate Cancer
5 participants

PRIMARY outcome

Timeframe: An average of every 2 weeks while on therapy

Toxicity rates will be summarized by point estimates and Wilson type 90% confidence intervals. Toxicities will be graded per the National Cancer Institute (NCI) Common Toxicity Criteria (CTC), and PSA response will be determined as per PSA Working Group response criteria. Censored time to PSA progression will be estimated with standard Kaplan-Meier methodology.

Outcome measures

Outcome measures
Measure
Treatment (Monoclonal Antibody, Antiangiogenesis)
n=15 Participants
Patients receive bevacizumab IV over 30-90 minutes once every 14 days. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity. bevacizumab: Given IV laboratory biomarker analysis: Correlative studies
Toxicities Associated With Bevacizumab Therapy
14 participants

PRIMARY outcome

Timeframe: An average every 6 weeks for up to 3 months

TTPP will be measured from protocol registration to appearance of PSA progression as defined by the criteria of the PSA Working Group response criteria. The end point for progression will be calculated at the time a 25% increase in PSA has been achieved. PSA velocity will also be calculated as change in PSA doubling time pre and post therapy and the rate of PSA rise pre- and post-therapy.

Outcome measures

Outcome measures
Measure
Treatment (Monoclonal Antibody, Antiangiogenesis)
n=15 Participants
Patients receive bevacizumab IV over 30-90 minutes once every 14 days. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity. bevacizumab: Given IV laboratory biomarker analysis: Correlative studies
Time to PSA Progression (TTPP)
2.8 months
Interval 2.4 to 5.4

SECONDARY outcome

Timeframe: Every 3 months

Overall survival of androgen independent non-metastatic prostate cancer patients treated with bevacizumab. The number of patients still alive at the end of the study (median K-M estimate cannot be obtained due to the 86.7% censoring rate).

Outcome measures

Outcome measures
Measure
Treatment (Monoclonal Antibody, Antiangiogenesis)
n=15 Participants
Patients receive bevacizumab IV over 30-90 minutes once every 14 days. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity. bevacizumab: Given IV laboratory biomarker analysis: Correlative studies
Overall Survival of Androgen Independent Non-metastatic Prostate Cancer Patients Treated With Bevacizumab
13 Participants

SECONDARY outcome

Timeframe: Baseline, every 6 weeks while on therapy, and then every 3 months thereafter

PSA velocity with bevacizumab therapy in androgen independent non-metastatic prostate cancer pre-therapy, as well as, PSA velocity with bevacizumab therapy while on therapy.

Outcome measures

Outcome measures
Measure
Treatment (Monoclonal Antibody, Antiangiogenesis)
n=15 Participants
Patients receive bevacizumab IV over 30-90 minutes once every 14 days. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity. bevacizumab: Given IV laboratory biomarker analysis: Correlative studies
The Change in PSA Velocity With Bevacizumab Therapy in Androgen Independent Non-metastatic Prostate Cancer
Pre-therapy
2.64 ng/ml/month
Interval 0.29 to 37.07
The Change in PSA Velocity With Bevacizumab Therapy in Androgen Independent Non-metastatic Prostate Cancer
On therapy
1.87 ng/ml/month
Interval 0.22 to 16.15

SECONDARY outcome

Timeframe: Every 3 months

Time to distant metastatic disease using the Kaplan-Meier method

Outcome measures

Outcome measures
Measure
Treatment (Monoclonal Antibody, Antiangiogenesis)
n=15 Participants
Patients receive bevacizumab IV over 30-90 minutes once every 14 days. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity. bevacizumab: Given IV laboratory biomarker analysis: Correlative studies
Time to Distant Metastatic Disease
7.9 months
Interval 3.2 to 17.6

Adverse Events

Treatment (Monoclonal Antibody, Antiangiogenesis)

Serious events: 4 serious events
Other events: 13 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Treatment (Monoclonal Antibody, Antiangiogenesis)
n=16 participants at risk
Patients receive bevacizumab IV over 30-90 minutes once every 14 days. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity. bevacizumab: Given IV laboratory biomarker analysis: Correlative studies
Vascular disorders
Hypertension
12.5%
2/16 • Number of events 2
Renal and urinary disorders
Proteinuria
6.2%
1/16 • Number of events 1
Vascular disorders
Pulmonary Embolism
6.2%
1/16 • Number of events 1

Other adverse events

Other adverse events
Measure
Treatment (Monoclonal Antibody, Antiangiogenesis)
n=16 participants at risk
Patients receive bevacizumab IV over 30-90 minutes once every 14 days. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity. bevacizumab: Given IV laboratory biomarker analysis: Correlative studies
Investigations
ALT increase
6.2%
1/16 • Number of events 1
Investigations
AST Increase
12.5%
2/16 • Number of events 2
Gastrointestinal disorders
GERD
6.2%
1/16 • Number of events 1
Blood and lymphatic system disorders
Anemia
12.5%
2/16 • Number of events 2
Metabolism and nutrition disorders
Anorexia
6.2%
1/16 • Number of events 1
Musculoskeletal and connective tissue disorders
bone pain
6.2%
1/16 • Number of events 1
Injury, poisoning and procedural complications
Bruising
6.2%
1/16 • Number of events 1
General disorders
Chills
6.2%
1/16 • Number of events 1
Gastrointestinal disorders
Constipation
6.2%
1/16 • Number of events 1
Respiratory, thoracic and mediastinal disorders
Cough
6.2%
1/16 • Number of events 1
Gastrointestinal disorders
Diarrhea
18.8%
3/16 • Number of events 3
General disorders
Edema
6.2%
1/16 • Number of events 1
Investigations
Elevated Creatinine
12.5%
2/16 • Number of events 2
General disorders
Fatigue
43.8%
7/16 • Number of events 7
General disorders
Generalized Pain
6.2%
1/16 • Number of events 1
Nervous system disorders
headache
6.2%
1/16 • Number of events 1
Renal and urinary disorders
Hematuria
12.5%
2/16 • Number of events 2
Gastrointestinal disorders
Hemorrhage GI
6.2%
1/16 • Number of events 1
Gastrointestinal disorders
Hemorrhage GU
6.2%
1/16 • Number of events 1
Gastrointestinal disorders
Hemorrhage GU-prostate/urethra
6.2%
1/16 • Number of events 1
Respiratory, thoracic and mediastinal disorders
Hemorrhage nose
12.5%
2/16 • Number of events 2
Gastrointestinal disorders
Hemorrhage oral cavity
6.2%
1/16 • Number of events 1
Metabolism and nutrition disorders
Hyperglycemia
6.2%
1/16 • Number of events 1
Vascular disorders
Hypertension
6.2%
1/16 • Number of events 8
Metabolism and nutrition disorders
Hypoglycemia
6.2%
1/16 • Number of events 1
Metabolism and nutrition disorders
Hyponatremia
6.2%
1/16 • Number of events 1
Investigations
Leukopenia
6.2%
1/16 • Number of events 1
Musculoskeletal and connective tissue disorders
Lower Extremity swelling
6.2%
1/16 • Number of events 1
Musculoskeletal and connective tissue disorders
myalgia
12.5%
2/16 • Number of events 2
Gastrointestinal disorders
nausea
12.5%
2/16 • Number of events 2
Renal and urinary disorders
Proteinuria
37.5%
6/16 • Number of events 6
Investigations
Thrombocytopenia
6.2%
1/16 • Number of events 1
Renal and urinary disorders
Urine color change
6.2%
1/16 • Number of events 1
Gastrointestinal disorders
Vomiting
6.2%
1/16 • Number of events 1
Musculoskeletal and connective tissue disorders
Weakness
6.2%
1/16 • Number of events 1
Investigations
weight loss
6.2%
1/16 • Number of events 1

Additional Information

Ulka Vaishampayan, M.D.

Barbara Ann Karmanos Cancer Institute

Phone: (313) 576-8718

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place