Full Text View
Tabular View
No Study Results Posted
Related Studies
Paclitaxel and Carboplatin in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
This study has been completed.
Study NCT00049257   Information provided by National Cancer Institute (NCI)
First Received: November 12, 2002   Last Updated: November 18, 2008   History of Changes

November 12, 2002
November 18, 2008
August 2002
October 2008   (final data collection date for primary outcome measure)
  • Prostate-specific antigen (PSA) response rate [ Designated as safety issue: No ]
  • Time to PSA progression [ Designated as safety issue: No ]
  • Prostate-specific antigen (PSA) response rate
  • Time to PSA progression
Complete list of historical versions of study NCT00049257 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Objective response rate
  • Time to measurable or evaluable disease progression
  • Overall survival rate
 
Paclitaxel and Carboplatin in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
A Phase II Trial of Paclitaxel and Carboplatin in the Treatment of Hormone-Refractory Prostate Cancer (HRPC)

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.

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.

Phase II
Interventional
Treatment, Open Label
Prostate Cancer
  • Drug: carboplatin
  • Drug: paclitaxel
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
60
 
October 2008   (final data collection date for primary outcome measure)

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)
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00049257
 
CDR0000258050, UCLA-0202092, BMS-UCLA-020209201, NCI-G02-2121
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Fairooz F. Kabbinavar, MD Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP