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Paclitaxel and Carboplatin in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
This study has been completed.
First Received: November 12, 2002   Last Updated: November 18, 2008   History of Changes
Sponsors and Collaborators: Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00049257
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining paclitaxel with carboplatin in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.


Condition Intervention Phase
Prostate Cancer
Drug: carboplatin
Drug: paclitaxel
Phase II

MedlinePlus related topics: Cancer Prostate Cancer
Drug Information available for: Paclitaxel Carboplatin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Trial of Paclitaxel and Carboplatin in the Treatment of Hormone-Refractory Prostate Cancer (HRPC)

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Prostate-specific antigen (PSA) response rate [ Designated as safety issue: No ]
  • Time to PSA progression [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective response rate [ Designated as safety issue: No ]
  • Time to measurable or evaluable disease progression [ Designated as safety issue: No ]
  • Overall survival rate [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: August 2002
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • WBC at least 3,000/mm^3
  • Absolute granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • 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

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00049257

Locations
United States, California
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
Principal Investigator: Fairooz F. Kabbinavar, MD Jonsson Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000258050, UCLA-0202092, BMS-UCLA-020209201, NCI-G02-2121
Study First Received: November 12, 2002
Last Updated: November 18, 2008
ClinicalTrials.gov Identifier: NCT00049257     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the prostate
recurrent prostate cancer
stage IV prostate cancer

Study placed in the following topic categories:
Genital Neoplasms, Male
Prostatic Diseases
Urogenital Neoplasms
Carboplatin
Antimitotic Agents
Genital Diseases, Male
Hormones
Recurrence
Paclitaxel
Tubulin Modulators
Adenocarcinoma
Prostatic Neoplasms
Antineoplastic Agents, Phytogenic

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Genital Neoplasms, Male
Prostatic Diseases
Antineoplastic Agents
Mitosis Modulators
Urogenital Neoplasms
Antimitotic Agents
Carboplatin
Genital Diseases, Male
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Paclitaxel
Therapeutic Uses
Tubulin Modulators
Antineoplastic Agents, Phytogenic
Prostatic Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009