Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Docetaxel in Treating Patients Who Have Undergone Surgery for Prostate Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	NCI, Pharmaceutical / Industry	AVENTIS-XRP6976J/2501 RPCI-DS-0212, NCT00054509

Objectives

1. 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.
2. Determine the time to disease progression in patients treated with this drug.
3. Determine the safety and tolerability of this drug in these patients.

Entry 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

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

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• Neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³
• 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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

Sanofi-Aventis - US - Bridgewater

Aventis Oncology		Ph: 800-798-7425 Email: contactus@1800rxtrial.com

Registry Information
Official Title		A Multicenter, Open-Label, Phase II Trial of Adjuvant Taxotere in Patients at High Risk of Relapse Following Prostatectomy
Trial Start Date		2002-07-23
Registered in ClinicalTrials.gov		NCT00054509
Date Submitted to PDQ		2003-01-07
Information Last Verified		2004-07-16
NCI Grant/Contract Number		P30-CA16056

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