RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Docetaxel may kill any remaining tumor cells following surgery.

PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating patients who have undergone surgery for prostate cancer.

Condition	Treatment or Intervention	Phase
stage I prostate cancer stage II prostate cancer stage III prostate cancer adenocarcinoma of the prostate	Drug: docetaxel  Procedure: adjuvant therapy  Procedure: chemotherapy	Phase II

Further Study Details: 

OBJECTIVES:

• Determine, preliminarily, the efficacy of docetaxel, in terms of progression-free and 3-year survival rate, in patients with adenocarcinoma of the prostate at high risk of relapse after radical prostatectomy.
• Determine the time to disease progression in patients treated with this drug.
• Determine the safety and tolerability of this drug in these patients.

OUTLINE: This is an open-label, multicenter study.

Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 3 years.

PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study within 2 years.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the prostate* NOTE: *All other variants are excluded
• No evidence of metastatic prostate cancer by bone scan and chest x-ray
• Prior prostatectomy within the past 4-8 weeks required
• Prostate-specific antigen value obtained within 6 months prior to prostatectomy
• High risk of disease progression
• Weighted risk of recurrence greater than 2.84

PATIENT CHARACTERISTICS: Age

• 18 and over

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• Neutrophil count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3
• Hemoglobin at least 10 g/dL

Hepatic

• Bilirubin no greater than upper limit of normal (ULN)
• AST/ALT no greater than 1.5 times ULN if alkaline phosphatase no greater than ULN OR
• Alkaline phosphatase no greater than 4 times ULN if AST and ALT no greater than ULN
• No acute hepatitis

Renal

• Creatinine less than 1.5 times ULN
• No uncontrolled hypercalcemia

Cardiovascular

• No uncontrolled cardiac arrhythmias
• No uncontrolled angina
• No uncompensated congestive heart failure
• No superior vena cava syndrome

Other

• Fertile patients must use effective contraception during and for 1 year after study
• No other prior malignancy except adequately treated nonmelanoma skin cancer or a curatively treated malignancy (including superficial bladder cancer) without evidence of disease for the past 5 years
• No peripheral neuropathy greater than grade 1
• No other unstable medical condition
• No active infection
• No gastrointestinal bleeding
• No uncontrolled diabetes
• No dementia
• No seizures
• No psychological, familial, sociological, or geographical condition or other circumstance that would preclude study completion or follow-up
• No history of hypersensitivity to products containing polysorbate 80

PRIOR CONCURRENT THERAPY: Biologic therapy

• No concurrent anticancer biologic therapy

Chemotherapy

• No prior systemic chemotherapy for prostate cancer
• No other concurrent systemic anticancer chemotherapy

Endocrine therapy

• No prior systemic hormonal therapy for prostate cancer
• No concurrent corticosteroids (except inhaled or topical corticosteroids)
• No concurrent systemic anticancer hormonal therapy
• No concurrent dehydroepiandrosterone (DHEA)

Radiotherapy

• No prior radiotherapy
• No radiotherapy during and for at least 30 days after study

Surgery

• See Disease Characteristics

Other

• No other prior systemic anticancer therapy
• No prior enrollment into this study
• No other concurrent alternative therapies including the following:
• Saw palmetto
• Lycopene
• PC-SPES (all types)
• No other concurrent anticancer therapy
• No other concurrent systemic therapy

Maryland
      Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore,  Maryland,  21231,  United States
New Jersey
      Aventis Pharmaceuticals, Incorporated, Bridgewater,  New Jersey,  08807-2854,  United States

Study ID Numbers:  CDR0000270750; AVENTIS-XRP6976J/2501; RPCI-DS-0212
Record last reviewed:  August 2004
Last Updated:  October 13, 2004
Record first received:  February 5, 2003
ClinicalTrials.gov Identifier:  NCT00054509
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08