Paclitaxel Poliglumex and Estradiol in Treating Patients With Stage IV Prostate Cancer

This study has been terminated.

Study NCT00459810 Information provided by OHSU Knight Cancer Institute

First Received on April 11, 2007. Last Updated on June 1, 2011 History of Changes

Results First Received: May 25, 2010

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Prostate Cancer
Interventions:	Drug: transdermal estradiol Drug: paclitaxel poliglumex

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Twenty-one patients enrolled in the trial between March 2007 and May 2008 in the medical clinics at Oregon Health & Science University and the University of California at San Francisco.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Transdermal Estradiol and Paclitaxel Poliglumex	All subjects enrolled were treated with transdermal estradiol 0.2 mg/24 hours for 4 weeks followed by the same dose of transdermal estradiol and paclitaxel poliglumex PPX 150 mg/m2 IV every 28 days.

Participant Flow: Overall Study

	Transdermal Estradiol and Paclitaxel Poliglumex
STARTED	21
COMPLETED	21
NOT COMPLETED	0

Baseline Characteristics

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Reporting Groups

	Description
Transdermal Estradiol and Paclitaxel Poliglumex	All subjects enrolled were treated with transdermal estradiol 0.2 mg/24 hours for 4 weeks followed by the same dose of transdermal estradiol and paclitaxel poliglumex PPX 150 mg/m2 IV every 28 days.

Baseline Measures

	Transdermal Estradiol and Paclitaxel Poliglumex
Number of Participants [units: participants]	21
Age [units: participants]
<=18 years	0
Between 18 and 65 years	4
>=65 years	17
Age [units: years] Mean ± Standard Deviation	70 ± 7.6
Gender [units: participants]
Female	0
Male	21
Region of Enrollment [units: participants]
United States	21

Outcome Measures

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1. Primary:

Prostate Specific Antigen (PSA) Response Rate: Number of Subjects With Decreases in PSA of at Least 50% [ Time Frame: While receiving study agents (on average, 3 months) ]

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2. Secondary:

Measurable Disease Response Rate (Soft Tissue) [ Time Frame: While receiving study agents (on average, 3 months) ]

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3. Secondary:

Time to Disease Progression [ Time Frame: At time of progression by PSA or RECIST criteria ]

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4. Secondary:

Time to Death [ Time Frame: Measured at Date of Death from any cause ]

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5. Secondary:

Correlation of Levels of Serum Estradiol, Serum Cathepsin B, and Bone Turnover Markers With PSA Response [ Time Frame: Measured after 4 cycles of combination therapy ]

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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.

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
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Results Point of Contact:

Name/Title: Study Coordinator
Organization: Oregon Health & Science University Knight Cancer Institute
phone: (503) 494-2897
e-mail: eilersk@ohsu.edu

No publications provided

Responsible Party:	Tomasz M. Beer, OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:	NCT00459810 History of Changes
Other Study ID Numbers:	CDR0000540438, OHSU-2656
Study First Received:	April 11, 2007
Results First Received:	May 25, 2010
Last Updated:	June 1, 2011
Health Authority:	United States: Food and Drug Administration