Combination Chemotherapy Followed by Surgery in Treating Patients With Localized Prostate Cancer

This study is ongoing, but not recruiting participants.

Study NCT00017563 Information provided by OHSU Knight Cancer Institute

First Received on June 6, 2001. Last Updated on August 31, 2011 History of Changes

Results First Received: May 31, 2011

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Prostate Cancer
Interventions:	Drug: docetaxel Drug: mitoxantrone hydrochloride Procedure: conventional surgery

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
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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
Docetaxel and Mitox	Drug: docetaxel 35 mg/m2 i.v. over 15 - 30 minutes will be administered immediately after the mitoxantrone on the same schedule. Drug: mitoxantrone hydrochloride Initial dose will be 2 mg/m2 weekly for 3 of every 4 weeks. The dose will then be escalated as described in the dose escalation section up to a maximum dose of 6 mg/m2 weekly for 3 of every 4 weeks.

Description

Docetaxel and Mitox

Drug: docetaxel

35 mg/m2 i.v. over 15 - 30 minutes will be administered immediately after the mitoxantrone on the same schedule.

Drug: mitoxantrone hydrochloride

Initial dose will be 2 mg/m2 weekly for 3 of every 4 weeks. The dose will then be escalated as described in the dose escalation section up to a maximum dose of 6 mg/m2 weekly for 3 of every 4 weeks.

Participant Flow: Overall Study

	Docetaxel and Mitox
STARTED	57
COMPLETED	56
NOT COMPLETED	1

Baseline Characteristics

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Reporting Groups

	Description
Docetaxel and Mitox	Drug: docetaxel 35 mg/m2 i.v. over 15 - 30 minutes will be administered immediately after the mitoxantrone on the same schedule. Drug: mitoxantrone hydrochloride Initial dose will be 2 mg/m2 weekly for 3 of every 4 weeks. The dose will then be escalated as described in the dose escalation section up to a maximum dose of 6 mg/m2 weekly for 3 of every 4 weeks.

Description

Docetaxel and Mitox

Drug: docetaxel

35 mg/m2 i.v. over 15 - 30 minutes will be administered immediately after the mitoxantrone on the same schedule.

Drug: mitoxantrone hydrochloride

Initial dose will be 2 mg/m2 weekly for 3 of every 4 weeks. The dose will then be escalated as described in the dose escalation section up to a maximum dose of 6 mg/m2 weekly for 3 of every 4 weeks.

Baseline Measures

	Docetaxel and Mitox
Number of Participants [units: participants]	57
Age [units: participants]
<=18 years	0
Between 18 and 65 years	39
>=65 years	18
Age [units: years] Mean ± Standard Deviation	61.56 ± 6.279
Gender [units: participants]
Female	0
Male	57
Region of Enrollment [units: participants]
United States	57

Outcome Measures

1. Primary:

Number of Participants With 5-year Freedom From Prostate Specific Antigen (PSA) Recurrence. [ Time Frame: Every 3 months after surgery for up to 5 years. ]

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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 NOT 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.

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: Tomasz Beer, M.D.
Organization: OHSU Knight Cancer Institute
phone: 503-494-1080
e-mail: beert@ohsu.edu

No publications provided

Responsible Party:	OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:	NCT00017563 History of Changes
Other Study ID Numbers:	CDR0000068719, OHSU-6082, OHSU-HOR-00037-L, NCI-G01-1962
Study First Received:	June 6, 2001
Results First Received:	May 31, 2011
Last Updated:	August 31, 2011
Health Authority:	United States: Federal Government; United States: Food and Drug Administration