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

NCT ID: NCT00416533

Last Updated: 2017-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-08-31

Brief Summary

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.

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.

Conditions

Prostate Cancer

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

docetaxel

Intervention Type: DRUG

doxorubicin hydrochloride

Intervention Type: DRUG

prednisone

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frank M. Torti, MD, MPH

Role: STUDY_CHAIR

Wake Forest University Health Sciences

Other Identifiers

CDR0000466318

Identifier Type: REGISTRY

Identifier Source: secondary_id

CCCWFU-BG04-264

Identifier Type: -

Identifier Source: secondary_id

AVENTIS-CCCWFU-85302

Identifier Type: -

Identifier Source: secondary_id

CCCWFU-85302

Identifier Type: -

Identifier Source: org_study_id