Trial Outcomes & Findings for Study of Bevacizumab and Erlotinib for Patients With Hormone Refractory Prostate Cancer (NCT NCT00996502)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

4 participants

Primary outcome timeframe

After three 21-day cycles

Results posted on

2019-03-27

Participant Flow

The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to the IRB in March 2010.

Participant milestones

Participant milestones
Measure	Combination Regimen Bevacizumab, Erlotinib, Docetaxel, Prednisone (dose escalation) Phase I: * Cohort 1: 55mg/m2 of Docetaxel on Day 1 of the cycle, 15mg/kg of Bevacizumab every 3 weeks, 200 mg of Erlotinib PO daily days 2-16, 5 mg of Prednisone PO bid * Cohort 2: 65mg/m2 of Docetaxel on Day 1 of the cycle, 15mg/kg of Bevacizumab every 3 weeks, 200 mg of Erlotinib PO daily days 2-16, 5 mg of Prednisone PO bid * Cohort 3: 75mg/m2 of Docetaxel on Day 1 of the cycle, 15mg/kg of Bevacizumab every 3 weeks, 200 mg of Erlotinib PO daily days 2-16, 5 mg of Prednisone PO bid Docetaxel: Phase I: * Cohort 1: 55mg/m2 of Docetaxel on Day 1 of the cycle * Cohort 2: 65mg/m2 of Docetaxel on Day 1 of the cycle * Cohort 3: 75mg/m2 of Docetaxel on Day 1 of the cycle Bevacizumab: 15mg/kg of Bevacizumab every 3 weeks Erlotinib: 200 mg of Erlotinib PO daily days 2-16 Prednisone: 5 mg of Prednisone PO bid
Overall Study STARTED	4
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Bevacizumab and Erlotinib for Patients With Hormone Refractory Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Combination Regimen n=4 Participants Bevacizumab, Erlotinib, Docetaxel, Prednisone (dose escalation) Phase I: * Cohort 1: 55mg/m2 of Docetaxel on Day 1 of the cycle, 15mg/kg of Bevacizumab every 3 weeks, 200 mg of Erlotinib PO daily days 2-16, 5 mg of Prednisone PO bid * Cohort 2: 65mg/m2 of Docetaxel on Day 1 of the cycle, 15mg/kg of Bevacizumab every 3 weeks, 200 mg of Erlotinib PO daily days 2-16, 5 mg of Prednisone PO bid * Cohort 3: 75mg/m2 of Docetaxel on Day 1 of the cycle, 15mg/kg of Bevacizumab every 3 weeks, 200 mg of Erlotinib PO daily days 2-16, 5 mg of Prednisone PO bid Docetaxel: Phase I: * Cohort 1: 55mg/m2 of Docetaxel on Day 1 of the cycle * Cohort 2: 65mg/m2 of Docetaxel on Day 1 of the cycle * Cohort 3: 75mg/m2 of Docetaxel on Day 1 of the cycle Bevacizumab: 15mg/kg of Bevacizumab every 3 weeks Erlotinib: 200 mg of Erlotinib PO daily days 2-16 Prednisone: 5 mg of Prednisone PO bid
Age, Customized 18 years and older	4 participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants

PRIMARY outcome

Timeframe: After three 21-day cycles

Population: The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in March 2010.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Every 9 weeks

Population: The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in March 2010.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Population: The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in March 2010.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: One year

Population: The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in March 2010.

Outcome measures

Outcome data not reported

Adverse Events

Combination Regimen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

CU PRS Administrator

Columbia University

Phone: 212-342-1643

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place