Docetaxel in Treating Patients With Relapsed Prostate Cancer

This study has been terminated.
(Drug supplier stopped funding due to loss of study drug (docetaxel) patent.)
Sponsor:
Collaborator:
Information provided by:
OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT00482274
First received: June 4, 2007
Last updated: July 5, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: docetaxel
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by OHSU Knight Cancer Institute:

Primary Outcome Measures:
  • Number of Participants With a Complete Response as Measured by Serum PSA Less Than 0.2 ng/ml [ Time Frame: While receiving study treatment (approximately 6 months) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Average Time for Participants to Develop PSA Recurrence (PSA > 0.2ng/ml) [ Time Frame: Average days to develop recurrence from treatment start date amount applicable participants ] [ Designated as safety issue: No ]
    Average time for participants to develop PSA recurrence (PSA > 0.2ng/ml). Due to the limited enrollment, this analysis was not completed.

  • Time to Metastatic Disease [ Time Frame: Measured at Time of documented metastases (no historical estimate is available) ] [ Designated as safety issue: No ]
    Due to the limited enrollment, this analysis was not completed.

  • Time to Androgen Independent State [ Time Frame: Measured at date of documented androgen independence (no estimate available) ] [ Designated as safety issue: No ]
    Due to the limited enrollment, this analysis was not completed.

  • Time to Death From Any Cause [ Time Frame: measured at date of death (no estimate available) ] [ Designated as safety issue: No ]
    Due to the limited enrollment, this analysis was not completed.


Enrollment: 3
Study Start Date: May 2007
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: docetaxel
    Docetaxel 75 mg/m2 intravenously (IV) over 60 minutes will be given on day 1 of each 21 day cycle.
    Other Name: Taxotere
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00482274

Locations
United States, Oregon
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239-3098
United States, Washington
University Cancer Center at University of Washington Medical Center
Seattle, Washington, United States, 98195-6043
Sponsors and Collaborators
OHSU Knight Cancer Institute
Investigators
Principal Investigator: Tomasz M. Beer, MD OHSU Knight Cancer Institute
  More Information

No publications provided

Responsible Party: Tomasz M. Beer, OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT00482274     History of Changes
Other Study ID Numbers: CDR0000546975, P30CA069533, OHSU-2838, OHSU-SOL-06076-LM
Study First Received: June 4, 2007
Results First Received: July 27, 2010
Last Updated: July 5, 2011
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by OHSU Knight Cancer Institute:
adenocarcinoma of the prostate
recurrent prostate cancer
stage I prostate cancer
stage II prostate cancer
stage III prostate cancer
stage IV prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014