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Docetaxel in Treating Patients With Relapsed Prostate Cancer

Primary Purpose

Prostate Cancer

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

docetaxel

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, recurrent prostate cancer, stage I prostate cancer, stage II prostate cancer, stage III prostate cancer, stage IV prostate cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Criteria for Patient eligibility

Inclusion criteria

Histologically confirmed adenocarcinoma of the prostate.
Prior primary therapy for prostate cancer, including radical prostatectomy, external beam radiation therapy, or brachytherapy.
Serum PSA > 0.2 ng/dL following 8 months of androgen deprivation therapy or a nadir PSA >0.2 ng/dL and at least 1 subsequent PSA values at the same or higher level, if prior to 8 months.
Serum testosterone < 50 ng/ml.
No evidence of metastases on bone scan.
No evidence of metastases on CT scan of the abdomen and pelvis.
ECOG performance status < 2.
Laboratory criteria for entry: absolute neutrophil count ≥ 1.2 K/cu mm, platelets ≥ 100 K/cu mm, serum bilirubin ≤ upper limit of normal (ULN), SGOT and SGPT ≤ 1.5 times institutional ULN if alkaline phosphatase ≤ ULN, alkaline phosphatase ≤ 5 times ULN if SGOT and SGPT are ≤ ULN, a serum creatinine ≤ 2 times institutional ULN.
Signed informed consent.

Exclusion Criteria

A second active malignancy during the last 5 years, except adequately treated non-melanoma skin cancer.
Life expectancy < 3 months.
Grade 2 or higher peripheral neuropathy.
Prior investigational agent within the past 28 days.
Less than a 10% decrease (or continued rise) in PSA in response to initial androgen-deprivation therapy.
More than 12 months since initiation of androgen-deprivation therapy.
Prior docetaxel chemotherapy.
Patients recently (within 28 days) started on corticosteroids, with the exception of inhaled and topical steroids. Patients on stable doses of systemic corticosteroids will be eligible.

Sites / Locations

OHSU Knight Cancer Institute
University Cancer Center at University of Washington Medical Center

Outcomes

Primary Outcome Measures

Number of Participants With a Complete Response as Measured by Serum PSA Less Than 0.2 ng/ml

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

Average Time for Participants to Develop PSA Recurrence (PSA > 0.2ng/ml)

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

Due to the limited enrollment, this analysis was not completed.

Time to Androgen Independent State

Due to the limited enrollment, this analysis was not completed.

Time to Death From Any Cause

Due to the limited enrollment, this analysis was not completed.

Full Information

NCT ID

NCT00482274

First Posted

June 4, 2007

Last Updated

April 26, 2017

Sponsor

OHSU Knight Cancer Institute

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00482274

Brief Title

Docetaxel in Treating Patients With Relapsed Prostate Cancer

Official Title

Phase II Study of the Early Use of Docetaxel in Patients With Biochemical Relapse After Primary Therapy for Prostate Cancer and an Incomplete Response to Androgen Deprivation Therapy.

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Terminated

Why Stopped

Drug supplier stopped funding due to loss of study drug (docetaxel) patent.

Study Start Date

May 2007 (undefined)

Primary Completion Date

July 2009 (Actual)

Study Completion Date

July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

OHSU Knight Cancer Institute

Collaborators

National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

adenocarcinoma of the prostate, recurrent prostate cancer, stage I prostate cancer, stage II prostate cancer, stage III prostate cancer, stage IV prostate cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

docetaxel

Other Intervention Name(s)

Taxotere

Intervention Description

Docetaxel 75 mg/m2 intravenously (IV) over 60 minutes will be given on day 1 of each 21 day cycle.

Primary Outcome Measure Information:

Title

Number of Participants With a Complete Response as Measured by Serum PSA Less Than 0.2 ng/ml

Description

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.

Time Frame

While receiving study treatment (approximately 6 months)

Secondary Outcome Measure Information:

Title

Average Time for Participants to Develop PSA Recurrence (PSA > 0.2ng/ml)

Description

Average time for participants to develop PSA recurrence (PSA > 0.2ng/ml). Due to the limited enrollment, this analysis was not completed.

Time Frame

Average days to develop recurrence from treatment start date amount applicable participants

Title

Time to Metastatic Disease

Description

Due to the limited enrollment, this analysis was not completed.

Time Frame

Measured at Time of documented metastases (no historical estimate is available)

Title

Time to Androgen Independent State

Description

Due to the limited enrollment, this analysis was not completed.

Time Frame

Measured at date of documented androgen independence (no estimate available)

Title

Time to Death From Any Cause

Description

Due to the limited enrollment, this analysis was not completed.

Time Frame

measured at date of death (no estimate available)

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Criteria for Patient eligibility Inclusion criteria Histologically confirmed adenocarcinoma of the prostate. Prior primary therapy for prostate cancer, including radical prostatectomy, external beam radiation therapy, or brachytherapy. Serum PSA > 0.2 ng/dL following 8 months of androgen deprivation therapy or a nadir PSA >0.2 ng/dL and at least 1 subsequent PSA values at the same or higher level, if prior to 8 months. Serum testosterone < 50 ng/ml. No evidence of metastases on bone scan. No evidence of metastases on CT scan of the abdomen and pelvis. ECOG performance status < 2. Laboratory criteria for entry: absolute neutrophil count ≥ 1.2 K/cu mm, platelets ≥ 100 K/cu mm, serum bilirubin ≤ upper limit of normal (ULN), SGOT and SGPT ≤ 1.5 times institutional ULN if alkaline phosphatase ≤ ULN, alkaline phosphatase ≤ 5 times ULN if SGOT and SGPT are ≤ ULN, a serum creatinine ≤ 2 times institutional ULN. Signed informed consent. Exclusion Criteria A second active malignancy during the last 5 years, except adequately treated non-melanoma skin cancer. Life expectancy < 3 months. Grade 2 or higher peripheral neuropathy. Prior investigational agent within the past 28 days. Less than a 10% decrease (or continued rise) in PSA in response to initial androgen-deprivation therapy. More than 12 months since initiation of androgen-deprivation therapy. Prior docetaxel chemotherapy. Patients recently (within 28 days) started on corticosteroids, with the exception of inhaled and topical steroids. Patients on stable doses of systemic corticosteroids will be eligible.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tomasz M. Beer, MD

Organizational Affiliation

OHSU Knight Cancer Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

OHSU Knight Cancer Institute

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239-3098

Country

United States

Facility Name

University Cancer Center at University of Washington Medical Center

City

Seattle

State/Province

Washington

ZIP/Postal Code

98195-6043

Country

United States

12. IPD Sharing Statement

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Docetaxel in Treating Patients With Relapsed Prostate Cancer

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