Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Objectives

Primary

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

Secondary

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

Entry 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

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

Patient Characteristics:

• ECOG performance status 0-1
• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• 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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

Wake Forest University Comprehensive Cancer Center

Frank Torti, MD, MPH, Protocol chair		Ph: 336-716-7971; 800-446-2255 Email: ftorti@wfubmc.edu

Registry Information
Official Title		A Phase II Study of Taxotere (Docetaxel) Plus Adriamycin (Doxorubicin) and Prednisone (TAP) in Hormone-Refractory Prostate Cancer
Registered in ClinicalTrials.gov		NCT00416533
Date Submitted to PDQ		2006-02-17
Information Last Verified		2007-05-13
NCI Grant/Contract Number		CA12197

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