Treatment of Prostate Cancer With Adjuvant Bevacizumab Plus Erlotinib - Study Results

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Prostate Cancer
Intervention:	Drug: Erlotinib + Bevacizumab

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Dates of recruitment period: 6/23/2005 - 03/10/2009 Types of location: Academic medical clinics and community medical clinics.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There are no pre-assignment details to describe.

Reporting Groups

	Description
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.

Description

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.

Participant Flow for 2 periods

Period 1: Treatment Period

	Erlotinib + Bevacizumab
STARTED	22 ^[1]
COMPLETED	11 ^[2]
NOT COMPLETED	11
Withdrawal by Subject	4
Adverse Event	5
progressive disease	2

[1]	23 subjects registered for treatment, 1 withdrew consent after registration,22 received treatment.
[2]	Of 11 pts that did not complete treatment,5 stopped due to adverse event and entered followup period

Period 2: Follow-up Period

	Erlotinib + Bevacizumab
STARTED	16 ^[1]
COMPLETED	10
NOT COMPLETED	6
Withdrawal by Subject	1
progressive disease	4
Lost to Follow-up	1

[1]	followup includes 11 pts that completed treatment + 5 pts who stopped treatment due to adverse event

Baseline Characteristics

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Reporting Groups

	Description
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.

Description

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.

Baseline Measures

	Erlotinib + Bevacizumab
Number of Participants [units: participants]	22
Age [units: years] Median ( Full Range )	67 ( 51 to 76 )
Gender [units: participants]
Female	0
Male	22
Race (NIH/OMB) [units: participants]
American Indian or Alaska Native	0
Asian	2
Native Hawaiian or Other Pacific Islander	0
Black or African American	0
White	20
More than one race	0
Unknown or Not Reported	0

Outcome Measures

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1. Primary:

To Evaluate the Efficacy of Bevacizumab Plus Erlotinib [ Time Frame: Determined by time to tumor recurrence, as measured by rising prostate specific antigen (PSA) after radical prostatectomy. ]

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2. Primary:

Time to Tumor Recurrence [ Time Frame: Tumor progression assessed every 3 months during Follow-up Period for a maximum of 3 years after administration of first study treatment ]

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3. Secondary:

Time to Tumor Progression. [ Time Frame: Tumor progression assessed every 3 months during Follow-up Period for a maximum of 3 years after administration of first study treatment ]

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4. Secondary:

Overall Survival [ Time Frame: Survival status was assessed every 3 months after completion of study treatment for a maximum of 3 years after administration of first study treatment ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
This was a small study with only 22 participants who received study treatment. With such a small sample size the study doesnt have the statistcical power to make categorical assessments or statements.

Results Point of Contact:

Name/Title: Dr. Fairooz F. Kabbinavar, Chief Medical Officer
Organization: Translational Oncology Research International
phone: 310-824-1934
e-mail: FKabbina@mednet.ucla.edu

No publications provided

Responsible Party:	Fairooz Kabbinavar, Translational Oncology Research International
ClinicalTrials.gov Identifier:	NCT00203424 History of Changes
Other Study ID Numbers:	TORI GU-01, 05-07-102
Study First Received:	September 13, 2005
Results First Received:	April 12, 2011
Last Updated:	May 24, 2011
Health Authority:	United States: Food and Drug Administration