Docetaxel in Treating Patients With Relapsed Prostate Cancer

OHSU Knight Cancer Institute

Status and phase: Terminated; Phase 2

Conditions: Prostate Cancer

Treatments: Drug: docetaxel

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00482274

OHSU-SOL-06076-LM (Other Identifier)

OHSU-2838 (Other Identifier)

P30CA069533 (U.S. NIH Grant/Contract)

CDR0000546975

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)