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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Comprehensive Cancer Center of Wake Forest University; Wake Forest University Health Sciences
• Collaborator: National Cancer Institute (NCI)
• Treatments: Docetaxel; Doxorubicin; Hormones; Liposomal doxorubicin; Prednisone

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