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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00416533
First Posted: December 28, 2006
Last Update Posted: January 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences
  Purpose

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.


Condition Intervention Phase
Prostate Cancer Drug: docetaxel Drug: doxorubicin hydrochloride Drug: prednisone Phase 2

Study Type: Interventional
Study Design: Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Taxotere (Docetaxel) Plus Adriamycin (Doxorubicin) and Prednisone (TAP) in Hormone-Refractory Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Wake Forest University Health Sciences:

Estimated Enrollment: 47
Study Start Date: August 2004
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00416533


Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Investigators
Study Chair: Frank M. Torti, MD, MPH Wake Forest University Health Sciences
  More Information

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT00416533     History of Changes
Other Study ID Numbers: CCCWFU-85302
CDR0000466318 ( Registry Identifier: PDQ (Physician Data Query) )
CCCWFU-BG04-264
AVENTIS-CCCWFU-85302
First Submitted: December 27, 2006
First Posted: December 28, 2006
Last Update Posted: January 19, 2017
Last Verified: June 2013

Keywords provided by Wake Forest University Health Sciences:
recurrent prostate cancer
stage III prostate cancer
stage IV prostate cancer
adenocarcinoma of the prostate

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Docetaxel
Liposomal doxorubicin
Doxorubicin
Prednisone
Hormones
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Anti-Inflammatory Agents
Glucocorticoids
Antineoplastic Agents, Hormonal