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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:
Collaborator:
Information provided by:
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT00416533
First received: December 27, 2006
Last updated: June 4, 2013
Last verified: June 2013
  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: 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 Comprehensive Cancer Center of Wake Forest University:

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

Ages Eligible for Study:   18 Years and older
Genders 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
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: NCT00416533

Sponsors and Collaborators
Comprehensive Cancer Center of Wake Forest University
Investigators
Study Chair: Frank M. Torti, MD, MPH Comprehensive Cancer Center of Wake Forest University
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00416533     History of Changes
Other Study ID Numbers: CCCWFU-85302, CDR0000466318, CCCWFU-BG04-264, AVENTIS-CCCWFU-85302
Study First Received: December 27, 2006
Last Updated: June 4, 2013
Health Authority: United States: Federal Government

Keywords provided by Comprehensive Cancer Center of Wake Forest University:
recurrent prostate cancer
stage III prostate cancer
stage IV prostate cancer
adenocarcinoma of the prostate

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

ClinicalTrials.gov processed this record on November 27, 2014