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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.


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

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Trial Information

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.


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.

Inclusion Criteria


Criteria for Patient eligibility

Inclusion criteria

1. Histologically confirmed adenocarcinoma of the prostate.

2. Prior primary therapy for prostate cancer, including radical prostatectomy, external
beam radiation therapy, or brachytherapy.

3. 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.

4. Serum testosterone < 50 ng/ml.

5. No evidence of metastases on bone scan.

6. No evidence of metastases on CT scan of the abdomen and pelvis.

7. ECOG performance status < 2.

8. 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.

9. Signed informed consent.

Exclusion Criteria

1. A second active malignancy during the last 5 years, except adequately treated
non-melanoma skin cancer.

2. Life expectancy < 3 months.

3. Grade 2 or higher peripheral neuropathy.

4. Prior investigational agent within the past 28 days.

5. Less than a 10% decrease (or continued rise) in PSA in response to initial
androgen-deprivation therapy.

6. More than 12 months since initiation of androgen-deprivation therapy.

7. Prior docetaxel chemotherapy.

8. 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.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome 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.

Outcome Time Frame:

While receiving study treatment (approximately 6 months)

Safety Issue:

No

Principal Investigator

Tomasz M. Beer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

OHSU Knight Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000546975

NCT ID:

NCT00482274

Start Date:

May 2007

Completion Date:

July 2009

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • recurrent prostate cancer
  • stage I prostate cancer
  • stage II prostate cancer
  • stage III prostate cancer
  • stage IV prostate cancer
  • Prostatic Neoplasms

Name

Location

University Cancer Center at University of Washington Medical CenterSeattle, Washington  98195
OHSU Knight Cancer InstitutePortland, Oregon  97239