Trial Outcomes & Findings for Treatment of Prostate Cancer With Adjuvant Bevacizumab Plus Erlotinib (NCT NCT00203424)
NCT ID: NCT00203424
Last Updated: 2016-03-25
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
23 participants
Primary outcome timeframe
Determined by time to tumor recurrence, as measured by rising prostate specific antigen (PSA) after radical prostatectomy.
Results posted on
2016-03-25
Participant Flow
Dates of recruitment period: 6/23/2005 - 03/10/2009 Types of location: Academic medical clinics and community medical clinics.
There are no pre-assignment details to describe.
Participant milestones
| Measure |
Erlotinib + Bevacizumab
27 participants were screened for the study. 4 did not meet eligibility criteria,23 were registered to treatment period. 1 withdrew consent a day after registration and did not initiate study treatment.22 participants entered treatment period. Participants received Erlotinib every day for 24 weeks and Bevacizumab every 3 weeks for a total of 8 doses. The protocol instructed that pts be treated for 6 cycles. Of the 22 pts that started treatment, 11 completed the 6 cycles and the other 11 had to stop treatment prior to administration of 6th cycle. Of the 11 pts that did not complete all 6 cycles, 5 stopped treatment due to adverse event and were entered into the follow-up period. The 6 that stopped treatment due to withdrawal of consent and progressive disease did not enter the follow-up period. So 11 pts that completed 6 cycles of treatment plus 5 pts that did not complete 6 cycles of treatment due to an adverse event gives a total of 16 patients who entered follow-up period.
|
|---|---|
|
Treatment Period
STARTED
|
22
|
|
Treatment Period
COMPLETED
|
11
|
|
Treatment Period
NOT COMPLETED
|
11
|
|
Follow-up Period
STARTED
|
16
|
|
Follow-up Period
COMPLETED
|
10
|
|
Follow-up Period
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Erlotinib + Bevacizumab
27 participants were screened for the study. 4 did not meet eligibility criteria,23 were registered to treatment period. 1 withdrew consent a day after registration and did not initiate study treatment.22 participants entered treatment period. Participants received Erlotinib every day for 24 weeks and Bevacizumab every 3 weeks for a total of 8 doses. The protocol instructed that pts be treated for 6 cycles. Of the 22 pts that started treatment, 11 completed the 6 cycles and the other 11 had to stop treatment prior to administration of 6th cycle. Of the 11 pts that did not complete all 6 cycles, 5 stopped treatment due to adverse event and were entered into the follow-up period. The 6 that stopped treatment due to withdrawal of consent and progressive disease did not enter the follow-up period. So 11 pts that completed 6 cycles of treatment plus 5 pts that did not complete 6 cycles of treatment due to an adverse event gives a total of 16 patients who entered follow-up period.
|
|---|---|
|
Treatment Period
Withdrawal by Subject
|
4
|
|
Treatment Period
Adverse Event
|
5
|
|
Treatment Period
progressive disease
|
2
|
|
Follow-up Period
Withdrawal by Subject
|
1
|
|
Follow-up Period
progressive disease
|
4
|
|
Follow-up Period
Lost to Follow-up
|
1
|
Baseline Characteristics
Treatment of Prostate Cancer With Adjuvant Bevacizumab Plus Erlotinib
Baseline characteristics by cohort
| Measure |
Erlotinib + Bevacizumab
n=22 Participants
Participants that entered treatment period.
|
|---|---|
|
Age, Continuous
|
67 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Determined by time to tumor recurrence, as measured by rising prostate specific antigen (PSA) after radical prostatectomy.Population: Of the 23 subjects registered for treatment, 19 were analysed for efficacy, 4 subjects were excluded from analysis because of withdrawal of subjects prior to first tumor assessment.
Outcome measures
| Measure |
Bevacizumab+Erlotinib
n=19 Participants
|
|---|---|
|
To Evaluate the Efficacy of Bevacizumab Plus Erlotinib
completed study without tumor progression
|
9 participants
|
|
To Evaluate the Efficacy of Bevacizumab Plus Erlotinib
lost to follow-up unaffected by tumor recurrence
|
1 participants
|
|
To Evaluate the Efficacy of Bevacizumab Plus Erlotinib
withdrawal by subjects unaffected by recurrence
|
2 participants
|
|
To Evaluate the Efficacy of Bevacizumab Plus Erlotinib
affected by tumor recurrence
|
7 participants
|
PRIMARY outcome
Timeframe: Tumor progression assessed every 3 months during Follow-up Period for a maximum of 3 years after administration of first study treatmentOutcome measures
| Measure |
Bevacizumab+Erlotinib
n=7 Participants
|
|---|---|
|
Time to Tumor Recurrence
|
285 days
Interval 42.0 to 835.0
|
SECONDARY outcome
Timeframe: Tumor progression assessed every 3 months during Follow-up Period for a maximum of 3 years after administration of first study treatmentMeasured once for participants who experienced tumor recurrence per protocol. Imaging done to measure tumor progression only after documented tumor recurrence
Outcome measures
| Measure |
Bevacizumab+Erlotinib
n=1 Participants
|
|---|---|
|
Time to Tumor Progression.
|
314 days
|
SECONDARY outcome
Timeframe: Survival status was assessed every 3 months after completion of study treatment for a maximum of 3 years after administration of first study treatmentOutcome measures
| Measure |
Bevacizumab+Erlotinib
n=22 Participants
|
|---|---|
|
Overall Survival
Deceased
|
0 participants
|
|
Overall Survival
Alive
|
15 participants
|
|
Overall Survival
Lost to Follow-up
|
1 participants
|
|
Overall Survival
Withdrawal by subject
|
6 participants
|
Adverse Events
Erlotinib + Bevacizumab
Serious events: 1 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Erlotinib + Bevacizumab
n=22 participants at risk
Participants that entered treatment period.
|
|---|---|
|
Cardiac disorders
Grade 3 hypertension related to bevacizumab
|
4.5%
1/22 • Adverse event (AE)data collected between 11/30/2005 and 1/26/2011. Therefore AE reporting period is 5.16 years or 5 years and 2 months, approximately.
Systemic adverse event assessment occurred every 21 days through investigator assessment during Treatment Period and every 3 months during Follow-up Period.
|
Other adverse events
| Measure |
Erlotinib + Bevacizumab
n=22 participants at risk
Participants that entered treatment period.
|
|---|---|
|
Skin and subcutaneous tissue disorders
rash
|
72.7%
16/22 • Adverse event (AE)data collected between 11/30/2005 and 1/26/2011. Therefore AE reporting period is 5.16 years or 5 years and 2 months, approximately.
Systemic adverse event assessment occurred every 21 days through investigator assessment during Treatment Period and every 3 months during Follow-up Period.
|
|
Musculoskeletal and connective tissue disorders
Fatigue
|
68.2%
15/22 • Adverse event (AE)data collected between 11/30/2005 and 1/26/2011. Therefore AE reporting period is 5.16 years or 5 years and 2 months, approximately.
Systemic adverse event assessment occurred every 21 days through investigator assessment during Treatment Period and every 3 months during Follow-up Period.
|
|
Gastrointestinal disorders
Diarrhea
|
63.6%
14/22 • Adverse event (AE)data collected between 11/30/2005 and 1/26/2011. Therefore AE reporting period is 5.16 years or 5 years and 2 months, approximately.
Systemic adverse event assessment occurred every 21 days through investigator assessment during Treatment Period and every 3 months during Follow-up Period.
|
|
Skin and subcutaneous tissue disorders
Acne
|
45.5%
10/22 • Adverse event (AE)data collected between 11/30/2005 and 1/26/2011. Therefore AE reporting period is 5.16 years or 5 years and 2 months, approximately.
Systemic adverse event assessment occurred every 21 days through investigator assessment during Treatment Period and every 3 months during Follow-up Period.
|
|
Cardiac disorders
Hypertension
|
40.9%
9/22 • Adverse event (AE)data collected between 11/30/2005 and 1/26/2011. Therefore AE reporting period is 5.16 years or 5 years and 2 months, approximately.
Systemic adverse event assessment occurred every 21 days through investigator assessment during Treatment Period and every 3 months during Follow-up Period.
|
|
General disorders
Pain
|
36.4%
8/22 • Adverse event (AE)data collected between 11/30/2005 and 1/26/2011. Therefore AE reporting period is 5.16 years or 5 years and 2 months, approximately.
Systemic adverse event assessment occurred every 21 days through investigator assessment during Treatment Period and every 3 months during Follow-up Period.
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
36.4%
8/22 • Adverse event (AE)data collected between 11/30/2005 and 1/26/2011. Therefore AE reporting period is 5.16 years or 5 years and 2 months, approximately.
Systemic adverse event assessment occurred every 21 days through investigator assessment during Treatment Period and every 3 months during Follow-up Period.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
31.8%
7/22 • Adverse event (AE)data collected between 11/30/2005 and 1/26/2011. Therefore AE reporting period is 5.16 years or 5 years and 2 months, approximately.
Systemic adverse event assessment occurred every 21 days through investigator assessment during Treatment Period and every 3 months during Follow-up Period.
|
|
Blood and lymphatic system disorders
Epistaxis
|
31.8%
7/22 • Adverse event (AE)data collected between 11/30/2005 and 1/26/2011. Therefore AE reporting period is 5.16 years or 5 years and 2 months, approximately.
Systemic adverse event assessment occurred every 21 days through investigator assessment during Treatment Period and every 3 months during Follow-up Period.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
22.7%
5/22 • Adverse event (AE)data collected between 11/30/2005 and 1/26/2011. Therefore AE reporting period is 5.16 years or 5 years and 2 months, approximately.
Systemic adverse event assessment occurred every 21 days through investigator assessment during Treatment Period and every 3 months during Follow-up Period.
|
|
Infections and infestations
Infection
|
22.7%
5/22 • Adverse event (AE)data collected between 11/30/2005 and 1/26/2011. Therefore AE reporting period is 5.16 years or 5 years and 2 months, approximately.
Systemic adverse event assessment occurred every 21 days through investigator assessment during Treatment Period and every 3 months during Follow-up Period.
|
|
Blood and lymphatic system disorders
edema, limb
|
22.7%
5/22 • Adverse event (AE)data collected between 11/30/2005 and 1/26/2011. Therefore AE reporting period is 5.16 years or 5 years and 2 months, approximately.
Systemic adverse event assessment occurred every 21 days through investigator assessment during Treatment Period and every 3 months during Follow-up Period.
|
|
General disorders
fever
|
18.2%
4/22 • Adverse event (AE)data collected between 11/30/2005 and 1/26/2011. Therefore AE reporting period is 5.16 years or 5 years and 2 months, approximately.
Systemic adverse event assessment occurred every 21 days through investigator assessment during Treatment Period and every 3 months during Follow-up Period.
|
|
Gastrointestinal disorders
Anorexia
|
18.2%
4/22 • Adverse event (AE)data collected between 11/30/2005 and 1/26/2011. Therefore AE reporting period is 5.16 years or 5 years and 2 months, approximately.
Systemic adverse event assessment occurred every 21 days through investigator assessment during Treatment Period and every 3 months during Follow-up Period.
|
|
Gastrointestinal disorders
hemarrhoids
|
18.2%
4/22 • Adverse event (AE)data collected between 11/30/2005 and 1/26/2011. Therefore AE reporting period is 5.16 years or 5 years and 2 months, approximately.
Systemic adverse event assessment occurred every 21 days through investigator assessment during Treatment Period and every 3 months during Follow-up Period.
|
|
Gastrointestinal disorders
nausea
|
18.2%
4/22 • Adverse event (AE)data collected between 11/30/2005 and 1/26/2011. Therefore AE reporting period is 5.16 years or 5 years and 2 months, approximately.
Systemic adverse event assessment occurred every 21 days through investigator assessment during Treatment Period and every 3 months during Follow-up Period.
|
|
Skin and subcutaneous tissue disorders
dry skin
|
13.6%
3/22 • Adverse event (AE)data collected between 11/30/2005 and 1/26/2011. Therefore AE reporting period is 5.16 years or 5 years and 2 months, approximately.
Systemic adverse event assessment occurred every 21 days through investigator assessment during Treatment Period and every 3 months during Follow-up Period.
|
|
Gastrointestinal disorders
taste alteration
|
13.6%
3/22 • Adverse event (AE)data collected between 11/30/2005 and 1/26/2011. Therefore AE reporting period is 5.16 years or 5 years and 2 months, approximately.
Systemic adverse event assessment occurred every 21 days through investigator assessment during Treatment Period and every 3 months during Follow-up Period.
|
|
Metabolism and nutrition disorders
proteinuria
|
13.6%
3/22 • Adverse event (AE)data collected between 11/30/2005 and 1/26/2011. Therefore AE reporting period is 5.16 years or 5 years and 2 months, approximately.
Systemic adverse event assessment occurred every 21 days through investigator assessment during Treatment Period and every 3 months during Follow-up Period.
|
|
Nervous system disorders
mood alteration
|
13.6%
3/22 • Adverse event (AE)data collected between 11/30/2005 and 1/26/2011. Therefore AE reporting period is 5.16 years or 5 years and 2 months, approximately.
Systemic adverse event assessment occurred every 21 days through investigator assessment during Treatment Period and every 3 months during Follow-up Period.
|
|
General disorders
headache
|
13.6%
3/22 • Adverse event (AE)data collected between 11/30/2005 and 1/26/2011. Therefore AE reporting period is 5.16 years or 5 years and 2 months, approximately.
Systemic adverse event assessment occurred every 21 days through investigator assessment during Treatment Period and every 3 months during Follow-up Period.
|
|
General disorders
chills
|
9.1%
2/22 • Adverse event (AE)data collected between 11/30/2005 and 1/26/2011. Therefore AE reporting period is 5.16 years or 5 years and 2 months, approximately.
Systemic adverse event assessment occurred every 21 days through investigator assessment during Treatment Period and every 3 months during Follow-up Period.
|
|
General disorders
cold symptoms
|
9.1%
2/22 • Adverse event (AE)data collected between 11/30/2005 and 1/26/2011. Therefore AE reporting period is 5.16 years or 5 years and 2 months, approximately.
Systemic adverse event assessment occurred every 21 days through investigator assessment during Treatment Period and every 3 months during Follow-up Period.
|
|
General disorders
insomnia
|
9.1%
2/22 • Adverse event (AE)data collected between 11/30/2005 and 1/26/2011. Therefore AE reporting period is 5.16 years or 5 years and 2 months, approximately.
Systemic adverse event assessment occurred every 21 days through investigator assessment during Treatment Period and every 3 months during Follow-up Period.
|
|
Skin and subcutaneous tissue disorders
peeling skin
|
9.1%
2/22 • Adverse event (AE)data collected between 11/30/2005 and 1/26/2011. Therefore AE reporting period is 5.16 years or 5 years and 2 months, approximately.
Systemic adverse event assessment occurred every 21 days through investigator assessment during Treatment Period and every 3 months during Follow-up Period.
|
|
Gastrointestinal disorders
constipation
|
9.1%
2/22 • Adverse event (AE)data collected between 11/30/2005 and 1/26/2011. Therefore AE reporting period is 5.16 years or 5 years and 2 months, approximately.
Systemic adverse event assessment occurred every 21 days through investigator assessment during Treatment Period and every 3 months during Follow-up Period.
|
|
Gastrointestinal disorders
vomiting
|
9.1%
2/22 • Adverse event (AE)data collected between 11/30/2005 and 1/26/2011. Therefore AE reporting period is 5.16 years or 5 years and 2 months, approximately.
Systemic adverse event assessment occurred every 21 days through investigator assessment during Treatment Period and every 3 months during Follow-up Period.
|
|
Vascular disorders
rectal bleeding
|
9.1%
2/22 • Adverse event (AE)data collected between 11/30/2005 and 1/26/2011. Therefore AE reporting period is 5.16 years or 5 years and 2 months, approximately.
Systemic adverse event assessment occurred every 21 days through investigator assessment during Treatment Period and every 3 months during Follow-up Period.
|
|
Metabolism and nutrition disorders
AST elevated
|
9.1%
2/22 • Adverse event (AE)data collected between 11/30/2005 and 1/26/2011. Therefore AE reporting period is 5.16 years or 5 years and 2 months, approximately.
Systemic adverse event assessment occurred every 21 days through investigator assessment during Treatment Period and every 3 months during Follow-up Period.
|
|
Metabolism and nutrition disorders
hyperglycemia
|
9.1%
2/22 • Adverse event (AE)data collected between 11/30/2005 and 1/26/2011. Therefore AE reporting period is 5.16 years or 5 years and 2 months, approximately.
Systemic adverse event assessment occurred every 21 days through investigator assessment during Treatment Period and every 3 months during Follow-up Period.
|
|
Metabolism and nutrition disorders
hypokalemia
|
9.1%
2/22 • Adverse event (AE)data collected between 11/30/2005 and 1/26/2011. Therefore AE reporting period is 5.16 years or 5 years and 2 months, approximately.
Systemic adverse event assessment occurred every 21 days through investigator assessment during Treatment Period and every 3 months during Follow-up Period.
|
|
Metabolism and nutrition disorders
hyponatremia
|
9.1%
2/22 • Adverse event (AE)data collected between 11/30/2005 and 1/26/2011. Therefore AE reporting period is 5.16 years or 5 years and 2 months, approximately.
Systemic adverse event assessment occurred every 21 days through investigator assessment during Treatment Period and every 3 months during Follow-up Period.
|
|
Metabolism and nutrition disorders
serum total protein, decreased
|
9.1%
2/22 • Adverse event (AE)data collected between 11/30/2005 and 1/26/2011. Therefore AE reporting period is 5.16 years or 5 years and 2 months, approximately.
Systemic adverse event assessment occurred every 21 days through investigator assessment during Treatment Period and every 3 months during Follow-up Period.
|
|
Nervous system disorders
neuropathy
|
9.1%
2/22 • Adverse event (AE)data collected between 11/30/2005 and 1/26/2011. Therefore AE reporting period is 5.16 years or 5 years and 2 months, approximately.
Systemic adverse event assessment occurred every 21 days through investigator assessment during Treatment Period and every 3 months during Follow-up Period.
|
|
General disorders
dysuria
|
9.1%
2/22 • Adverse event (AE)data collected between 11/30/2005 and 1/26/2011. Therefore AE reporting period is 5.16 years or 5 years and 2 months, approximately.
Systemic adverse event assessment occurred every 21 days through investigator assessment during Treatment Period and every 3 months during Follow-up Period.
|
|
General disorders
throat sore
|
9.1%
2/22 • Adverse event (AE)data collected between 11/30/2005 and 1/26/2011. Therefore AE reporting period is 5.16 years or 5 years and 2 months, approximately.
Systemic adverse event assessment occurred every 21 days through investigator assessment during Treatment Period and every 3 months during Follow-up Period.
|
|
Respiratory, thoracic and mediastinal disorders
voice changes
|
9.1%
2/22 • Adverse event (AE)data collected between 11/30/2005 and 1/26/2011. Therefore AE reporting period is 5.16 years or 5 years and 2 months, approximately.
Systemic adverse event assessment occurred every 21 days through investigator assessment during Treatment Period and every 3 months during Follow-up Period.
|
|
Renal and urinary disorders
urinary frequency, increased
|
9.1%
2/22 • Adverse event (AE)data collected between 11/30/2005 and 1/26/2011. Therefore AE reporting period is 5.16 years or 5 years and 2 months, approximately.
Systemic adverse event assessment occurred every 21 days through investigator assessment during Treatment Period and every 3 months during Follow-up Period.
|
|
Renal and urinary disorders
urinary retention
|
9.1%
2/22 • Adverse event (AE)data collected between 11/30/2005 and 1/26/2011. Therefore AE reporting period is 5.16 years or 5 years and 2 months, approximately.
Systemic adverse event assessment occurred every 21 days through investigator assessment during Treatment Period and every 3 months during Follow-up Period.
|
Additional Information
Dr. Fairooz F. Kabbinavar, Chief Medical Officer
Translational Oncology Research International
Phone: 310-824-1934
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The obligations of confidentiality shall apply for a period of 5 years beyond termination of Agreement between Sponsor and PI,but do not apply to the extent information:is or later becomes generally known to the public;is obtained from third party without restriction who had legal right to disclose;is already possessed by PI,as demonstrated by recipient's written records predating receipt from Sponsor;or is required to be disclosed pursuant to a subpoena,law,regulation,or other legal proceeding.
- Publication restrictions are in place
Restriction type: OTHER