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

Condition(s) targeted: Prostate Cancer

Intervention: docetaxel (Drug); doxorubicin hydrochloride (Drug); prednisone (Drug); chemotherapy (Procedure)

Phase: Phase 2

Status: Completed

Sponsored by: Wake Forest University

Official(s) and/or principal investigator(s):
Frank M. Torti, MD, MPH, Study Chair, Affiliation: Wake Forest University

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.

Official title: A Phase II Study of Taxotere (Docetaxel) Plus Adriamycin (Doxorubicin) and Prednisone (TAP) in Hormone-Refractory Prostate Cancer

Study design: Treatment, Open Label

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

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

Clinical trial summary from the National Cancer Institute's PDQ® database

Last updated: October 25, 2007