Docetaxel in Treating Patients With Relapsed Prostate Cancer

NCT ID: NCT00482274

Last Updated: 2017-04-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2009-07-31

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

docetaxel

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

Intervention Type: DRUG

Other Intervention Names

Taxotere

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

OHSU Knight Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Tom Beer

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tomasz M. Beer, MD

Role: PRINCIPAL_INVESTIGATOR

OHSU Knight Cancer Institute

Locations

OHSU Knight Cancer Institute

Portland, Oregon, United States

University Cancer Center at University of Washington Medical Center

Seattle, Washington, United States

Countries

United States

Other Identifiers

P30CA069533

Identifier Type: NIH

Identifier Source: secondary_id

View Link

OHSU-2838

Identifier Type: OTHER

Identifier Source: secondary_id

OHSU-SOL-06076-LM

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000546975

Identifier Type: -

Identifier Source: org_study_id