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CompletedNCT00416533Updated Jan 19, 2017

Docetaxel, Doxorubicin, and Prednisone in Treating Patients With Advanced Prostate Cancer That Has Not Responded to Hormone Therapy

A Phase 2 interventional study of docetaxel and doxorubicin hydrochloride in Prostate Cancer, sponsored by Wake Forest University Health Sciences. Completed. Open to male participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2017-01-19.

Sponsored by Wake Forest University Health Sciences · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
47
Ages
18 Years to 120 Years
Sex
Male
01

Study summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel, doxorubicin, and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving docetaxel, doxorubicin, and prednisone together works in treating patients with advanced prostate cancer that has not responded to hormone therapy.

Read the detailed description

OBJECTIVES:

Primary

  • Assess prostate specific antigen response rate to docetaxel, doxorubicin hydrochloride, and prednisone in patients with hormone-refractory advanced prostate cancer.

Secondary

  • Assess if treatment with docetaxel, doxorubicin hydrochloride, and prednisone will improve health-related quality of life of these patients.
  • Assess the toxicity of docetaxel, doxorubicin hydrochloride, and prednisone.
  • Assess response rate in measurable disease.

OUTLINE: Patients receive docetaxel IV over 1 hour on day 1, doxorubicin hydrochloride IV over 15 minutes on days 1 and 8, and oral prednisone once daily on days 1-21. Treatment repeats every 21 days for at least 3 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, on day 1 of each course, after completion of 3 courses, and at disease progression.

After completing study treatment, patients are followed every 6 months for 1 year.

PROJECTED ACCRUAL: A total of 47 patients will be accrued for this study.

02

Conditions studied

  • Prostate Cancer

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Keywords

  • recurrent prostate cancer
  • stage III prostate cancer
  • stage IV prostate cancer
  • adenocarcinoma of the prostate
03

In context

Prostatic Neoplasms

6,484 studies on the registry are indexed under Prostatic Neoplasms; 1,415 are open to participants now.

This study's planned enrollment of 47 is below the median of 58 across 4,908 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Wake Forest University Health Sciences is the lead sponsor of 1,345 studies on the registry; 198 are open to participants now.

Of its 328 completed or terminated interventional studies of FDA-regulated products, 249 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 120 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the prostate with any of the following:

    • Prostate-specific antigen ≥ 10 mg/dL
    • Bone disease
    • Bidimensional soft tissue disease
    • Evaluable disease
  • Advanced disease AND failed prior primary androgen ablation therapy, including anti-androgen withdrawal
  • Disease not amenable to local curative treatment
  • No known brain metastases

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • Absolute neutrophil count ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Creatinine \< 2.0 mg/dL
  • SGPT and SGOT \< 1.5 times upper limit of normal (ULN)
  • Bilirubin ≤ ULN
  • Hemoglobin ≥ 10 g/dL
  • Ejection fraction ≥ 50%
  • Peripheral neuropathy ≤ grade 1
  • Fertile patients must use effective contraception during and for 3 months after completion of study treatment
  • No previous history of or concurrent malignancy, except for any of the following:

    • Inactive nonmelanoma skin cancer
    • Disease-free for five or more years
    • Adequately treated stage I or II cancer from which patient is currently in complete remission
  • No other serious medical illness that would limit survival to less than 3 months
  • No psychiatric condition that would prevent informed consent
  • No active, uncontrolled bacterial, viral, or fungal infection
  • No hemorrhagic disorder
  • No history of severe hypersensitivity reaction to other drugs formulated with polysorbate 80

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No new hormonal treatment within the past 4 weeks
  • No prior immunotherapy, chemotherapy, or bone-seeking radiopharmaceuticals (e.g., strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium)
  • Prior bisphosphonates allowed
  • At least 2 weeks since prior radiotherapy
  • No other concurrent chemotherapy
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Masking
None (open label)
Enrollment
47 participants (estimated)
06

Study locations

No study locations are listed for this record.

07

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2004 and a primary completion of Oct 2006. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 27, 2006
First posted
Dec 28, 2006
Start
Aug 2004
Primary completionActual
Oct 2006
Last update
Jan 19, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 19, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00416533
Responsible party
Sponsor
First posted
Dec 28, 2006
Start date
Aug 2004
Primary completion
Oct 2006
Last update
Jan 19, 2017

Study contacts

Frank M. Torti, MD, MPH
study chair · Wake Forest University Health Sciences
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Docetaxel · Doxorubicin · Prednisone

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