Docetaxel in Treating Patients With Relapsed Prostate Cancer

Stopped early · Phase 2

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT00482274

Run by

OHSU Knight Cancer Institute

People needed

3

Starts

2007-05-01

Expected to finish

2009-07-01

Last updated by the study team

2017-04-28

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• OHSU Knight Cancer Institute — Portland, Oregon, United States
• University Cancer Center at University of Washington Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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