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A Phase II Trial of Paclitaxel and Carboplatin in the Treatment of Hormone-Refractory Prostate Cancer (HRPC)

Phase 2
18 Years
Not Enrolling
Prostate Cancer

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Trial Information

A Phase II Trial of Paclitaxel and Carboplatin in the Treatment of Hormone-Refractory Prostate Cancer (HRPC)


- 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.

- Determine the objective response rate, time to measurable or evaluable disease
progression, and overall survival in patients treated with this regimen.

- Determine the safety and toxicity of this regimen in these patients.

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.

PROJECTED ACCRUAL: Approximately 60 patients will be accrued for this study.

Inclusion Criteria:

- Patients must be informed of investigational nature of the study and written informed
consent must be obtained prior to study entry

- Patients >18 years of age

- Patients with a histologic diagnosis of adenocarcinoma of the prostate

- Patients must have metastatic disease with progression despite androgen ablation.
Patients who have not undergone orchiectomy must continue LHRH analogues. For
patients receiving LHRH analogues their testosterone level must be < 50ng/dL

- Patients with bidimensionally measurable disease or bone metastases that is not
progressive but who have a rising PSA are eligible

- Patients with an ECOG performance status <2

- Patients must have discontinued flutamide or nilutamide at least 4 weeks prior to the
first day of treatment with evidence of progressive disease. Patients must have
discontinued bicalutamide at least 6 weeks prior to registration with evidence of
progressive disease

- Patients with adequate hematological, renal, and hepatic function as defined by the
following required laboratory values:

- While blood cell count: > 3,000/mm3

- Absolute granulocyte count: > 1,500/mm3

- Platelets: > 100,000/mm3

- Hemoglobin: > 8.5 g/dL

- Total bilirubin: < 1.5 mg/dL

- Serum creatinine: < 2.5 mg/dL

- AST or ALT: < 2.5 x institutional upper limit of normal

- Patients may have received prior radiation therapy, provided at least 4 weeks have
elapsed since the conclusion of radiation therapy

Exclusion Criteria:

- Patients with biochemical only progression

- Patients who have received any prior chemotherapy for cancer of the prostate

- Patients who received antiandrogen therapy within 4 weeks prior to the first day of
treatment after cessation of flutamide or nilutamide, and or within 6 weeks prior to
registration after cessation of bicalutamide

- Patients receiving concomitant chemotherapy, biologic therapy, or radiation therapy

- Patients who have received Strontium 89 or other radioisotope therapies

- Patients with decreasing PSA levels following antiandrogen withdrawal

- Patients with > grade 1 peripheral sensory or motor neuropathy

- Patients with known carcinomatous meningitis or brain metastases are excluded

- Patients with past or current histories of neoplasm other than entry diagnosis except
for in-situ carcinoma of any site, non-melanoma skin cancer, or other malignancy
treated by surgery or radiation with a disease-free survival longer than 5 years

- Patients who have undergone major surgery < 3 weeks prior to registration, except for
biopsy or placement of a venous access device. Patients must have fully recovered
from all effects of any prior surgery

- Patients with histories of serious cardiac disease not adequately controlled:
documented myocardial infarction within the last 6 months preceding registration,
congestive heart failure, unstable angina, valvular disease with documented
ventricular compromise, uncontrolled hypertension, arrhythmia uncontrolled by
medication, clinically significant pericardial effusion

- Patients with active serious infections or other serious underlying medical
conditions that would otherwise impair their ability to receive protocol treatments

- Patients with dementia or significantly altered mental status that would prohibit the
understanding and/or giving of informed consent

- Patients receiving other investigational therapy

- Use of any investigational agent within 30 days of first day of treatment and use of
Ketoconazole, hydrocortisone, glucocorticoids, or megace within 30 days of first day
of treatment or other concomitant medications

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Prostate-specific Antigen (PSA) Response Rate

Outcome Description:

PSA response is defined as a decline from the baseline value of >=50% confirmed by a second PSA value 4 or more weeks later.

Outcome Time Frame:

Evaluated every 28 days during Treatment Period. Number of completed cycles among 58 treated patients range from 1 to 24 cycles with a median of 4.5 cycles. one cycle = 28 days.

Safety Issue:


Principal Investigator

Fairooz F. Kabbinavar, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Jonsson Comprehensive Cancer Center


United States: Federal Government

Study ID:




Start Date:

October 2002

Completion Date:

March 2009

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • recurrent prostate cancer
  • stage IV prostate cancer
  • Prostatic Neoplasms



Jonsson Comprehensive Cancer Center at UCLA Los Angeles, California  90095-1781