Docetaxel in Treating Patients With Relapsed Prostate Cancer

Phase 2

Terminated

• Conditions: Prostate Cancer

• Registration Number: NCT00482274
• Lead Sponsor: OHSU Knight Cancer Institute

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well docetaxel works in treating patients with relapsed prostate cancer.

Detailed Description

OBJECTIVES:

Primary

* Determine the complete response rate in patients with biochemically-relapsed, hormone-sensitive prostate cancer treated with docetaxel.

Secondary

* Determine the time to PSA recurrence in patients receiving this treatment.

* Determine the time to metastatic disease in patients receiving this treatment.

* Determine the time to androgen independent state in patients receiving this treatment.

* Determine the time to death from any cause in patients receiving this treatment.

OUTLINE: This is an open label study.

Patients receive docetaxel IV over 60 minutes on day 1. Treatment repeats every 21 days for 4-6 courses in the absence of unacceptable toxicity or disease progression.

After completion of study therapy, patients are followed periodically for up to 5 years.

PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-06-04
• Study First Submitted QC: 2007-06-04
• Study First Posted: 2007-06-05
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Results First Submitted: 2010-07-27
• Results First Submitted QC: 2010-07-27
• Results First Posted: 2010-08-24
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-26
• Last Update Posted: 2017-04-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 3

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of Participants With a Complete Response as Measured by Serum PSA Less Than 0.2 ng/ml	While receiving study treatment (approximately 6 months)	Complete response rate, as measured by PSA and defined as a PSA ≤0.2 ng/ml in PSA-relapsed, hormone-sensitive patients treated with docetaxel.

Secondary Outcome Measures

Name	Time	Method
Average Time for Participants to Develop PSA Recurrence (PSA > 0.2ng/ml)	Average days to develop recurrence from treatment start date amount applicable participants	Average time for participants to develop PSA recurrence (PSA \> 0.2ng/ml). Due to the limited enrollment, this analysis was not completed.
Time to Metastatic Disease	Measured at Time of documented metastases (no historical estimate is available)	Due to the limited enrollment, this analysis was not completed.
Time to Androgen Independent State	Measured at date of documented androgen independence (no estimate available)	Due to the limited enrollment, this analysis was not completed.
Time to Death From Any Cause	measured at date of death (no estimate available)	Due to the limited enrollment, this analysis was not completed.

Trial Locations

Locations (2)

University Cancer Center at University of Washington Medical Center; 🇺🇸 Seattle, Washington, United States

OHSU Knight Cancer Institute; 🇺🇸 Portland, Oregon, United States