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

Alternate Title

Paclitaxel and Carboplatin in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI, Pharmaceutical / Industry	UCLA-0202092 BMS-UCLA-020209201, NCI-G02-2121, NCT00049257

Objectives

1. Determine the prostate-specific antigen (PSA) response rate and time to PSA progression in patients with metastatic hormone-refractory prostate cancer treated with paclitaxel and carboplatin.
2. Determine the objective response rate, time to measurable or evaluable disease progression, and overall survival in patients treated with this regimen.
3. Determine the safety and toxicity of this regimen in these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed adenocarcinoma of the prostate



• Metastatic disease with progression despite androgen ablation (orchiectomy or luteinizing hormone-releasing hormone [LHRH] analogues)
  • Patients who have not undergone orchiectomy should continue LHRH analogues (e.g., leuprolide or goserelin)
  • Patients receiving LHRH analogues must have testosterone level less than 50 ng/dL
  • Disease progression defined as one of the following:
    • Progressive bidimensionally measurable disease independent of changes in PSA, bone scan, or performance status within past 30 days
    • At least 1 new lesion on bone scan within past 30 days and PSA at least 5 ng/mL



• Patients with bidimensionally measurable disease or bone metastases that are not progressive but who have a rising PSA (2 successive increases over at least 2 weeks) are eligible, provided pre-entry PSA is greater than 5 ng/mL

   [Note: Patients with elevated PSA as only evidence of disease are not eligible]




• No decreasing PSA levels after antiandrogen withdrawal



• No carcinomatous meningitis or brain metastases

Prior/Concurrent Therapy:

Biologic therapy

• No concurrent biologic therapy or immunotherapy

Chemotherapy

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

Endocrine therapy

• See Disease Characteristics
• At least 4 weeks since prior flutamide or nilutamide
• At least 6 weeks since prior bicalutamide
• No concurrent hormonal therapy (including megestrol)
• No concurrent anticancer hormonal therapy
• No concurrent steroids

Radiotherapy

• At least 4 weeks since prior radiotherapy
• No prior strontium chloride Sr 89 or other radioisotopes
• No concurrent radiotherapy

Surgery

• See Disease Characteristics
• More than 3 weeks since prior major surgery (excluding biopsy or venous access device placement) and recovered

Other

• No other concurrent investigational therapy
• No concurrent alternative or herbal therapies (including PC-SPES)

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• WBC at least 3,000/mm³
• Absolute granulocyte count at least 1,500/mm³
• Platelet count at least 100,000/mm³
• Hemoglobin at least 8.5 g/dL

Hepatic

• Bilirubin no greater than 1.5 mg/dL
• AST or ALT no greater than 2.5 times upper limit of normal

Renal

• Creatinine no greater than 2.5 mg/dL

Cardiovascular

• No history of uncontrolled serious cardiac disease
• No myocardial infarction within the past 6 months
• No congestive heart failure
• No unstable angina
• No valvular disease with documented ventricular compromise
• No uncontrolled hypertension
• No uncontrolled arrhythmia
• No clinically significant pericardial effusion

Other

• Fertile patients must use effective double-barrier contraception
• No peripheral sensory or motor neuropathy grade 2 or greater
• No other prior or concurrent malignancies except in situ carcinoma of any site, nonmelanoma skin cancer, or other malignancy treated with surgery or radiotherapy with a disease-free survival longer than 5 years
• No active serious infections
• No other serious underlying medical conditions that would preclude study
• No dementia or significantly altered mental status that would preclude informed consent

Expected Enrollment

Approximately 60 patients will be accrued for this study.

Outcomes

Prostate-specific antigen (PSA) response rate
Time to PSA progression

Objective response rate
Time to measurable or evaluable disease progression
Overall survival rate

Outline

This is an open-label study.

Patients receive paclitaxel IV on days 1, 8, and 15 and carboplatin IV on day 1. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 4 weeks for 12 weeks and then every 2 months thereafter.

Trial Contact Information

Trial Lead Organizations

Jonsson Comprehensive Cancer Center at UCLA

Fairooz Kabbinavar, MD, Principal investigator		Ph: 310-206-3921; 888-798-0719

Registry Information
Official Title		A Phase II Trial of Paclitaxel and Carboplatin in the Treatment of Hormone-Refractory Prostate Cancer (HRPC)
Trial Start Date		2002-08-30
Trial Completion Date		2008-10-31
Registered in ClinicalTrials.gov		NCT00049257
Date Submitted to PDQ		2002-09-11
Information Last Verified		2008-11-14
NCI Grant/Contract Number		CA16042

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