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

Phase 2
18 Years
Not Enrolling
Prostate Cancer

Thank you

Trial Information

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



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


- 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.

Inclusion Criteria


- 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


- 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


- 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

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Frank M. Torti, MD, MPH

Investigator Role:

Study Chair

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University


United States: Federal Government

Study ID:




Start Date:

August 2004

Completion Date:

Related Keywords:

  • Prostate Cancer
  • recurrent prostate cancer
  • stage III prostate cancer
  • stage IV prostate cancer
  • adenocarcinoma of the prostate
  • Prostatic Neoplasms