Docetaxel in Treating Patients With Relapsed Prostate Cancer

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.

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.

Study Overview

• Status: Terminated
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: docetaxel

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.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239-3098
      • OHSU Knight Cancer Institute
  • Washington
    • Seattle, Washington, United States, 98195-6043
      • University Cancer Center at University of Washington Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	While receiving study treatment (approximately 6 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Average days to develop recurrence from treatment start date amount applicable participants
Time to Metastatic Disease	Due to the limited enrollment, this analysis was not completed.	Measured at Time of documented metastases (no historical estimate is available)
Time to Androgen Independent State	Due to the limited enrollment, this analysis was not completed.	Measured at date of documented androgen independence (no estimate available)
Time to Death From Any Cause	Due to the limited enrollment, this analysis was not completed.	measured at date of death (no estimate available)

Collaborators and Investigators

• Sponsor: OHSU Knight Cancer Institute
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Tomasz M. Beer, MD, OHSU Knight Cancer Institute

Study record dates

Study Major Dates

• Study Start: May 1, 2007
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: June 4, 2007
• First Submitted That Met QC Criteria: June 4, 2007
• First Posted (Estimate): June 5, 2007

Study Record Updates

• Last Update Posted (Actual): April 28, 2017
• Last Update Submitted That Met QC Criteria: April 26, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: stage III prostate cancer; stage IV prostate cancer; recurrent prostate cancer; adenocarcinoma of the prostate; stage I prostate cancer; stage II prostate cancer
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel
• Other Study ID Numbers: CDR0000546975; P30CA069533 (U.S. NIH Grant/Contract); OHSU-2838 (Other Identifier: OHSU IRB); OHSU-SOL-06076-LM (Other Identifier: OHSU Knight Cancer Institute)