Docetaxel in Treating Patients With Relapsed Prostate Cancer

NCT00482274 | Terminated Phase 2 Results

• 4 other identifiers: CDR0000546975P30CA069533OHSU-2838OHSU-SOL-06076-LM
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 2

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.

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate; recurrent prostate cancer; stage I prostate cancer; stage II prostate cancer; stage III prostate cancer; stage IV prostate cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Average Time for Participants to Develop PSA Recurrence (PSA > 0.2ng/ml)

  Average days to develop recurrence from treatment start date amount applicable participants

• Time to Metastatic Disease

  Measured at Time of documented metastases (no historical estimate is available)

• Time to Androgen Independent State

  Measured at date of documented androgen independence (no estimate available)

• Time to Death From Any Cause

  measured at date of death (no estimate available)

Interventions

docetaxel DRUG

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

Also known as: Taxotere

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

OHSU Knight Cancer Institute

Portland, Oregon, 97239-3098, United States

Location

University Cancer Center at University of Washington Medical Center

Seattle, Washington, 98195-6043, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Limitations and Caveats

Due to withdrawal of sponsor support, this study was terminated after only 3 subjects were enrolled (of the planned 36 subjects). Sufficient data were not obtained to make statistically significant conclusions.

Results Point of Contact

• Title: Study Coordinator
• Organization: Oregon Health & Science University Knight Cancer Institute

eilersk@ohsu.edu

503 494-2897

Study Officials

• Tomasz M. Beer, MD

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 4, 2007
• First Posted: June 5, 2007
• Study Start: May 1, 2007
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: April 28, 2017
• Results First Posted: August 24, 2010

Record last verified: 2017-04

Locations

US (2)