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

This study has been completed.
Sponsor:
Collaborators:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00049257
First received: November 12, 2002
Last updated: August 2, 2012
Last verified: August 2012
  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 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Paclitaxel and Carboplatin in the Treatment of Hormone-Refractory Prostate Cancer (HRPC)

Resource links provided by NLM:


Further study details as provided by Jonsson Comprehensive Cancer Center:

Primary Outcome Measures:
  • Prostate-specific Antigen (PSA) Response Rate [ 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. ] [ Designated as safety issue: No ]
    PSA response is defined as a decline from the baseline value of >=50% confirmed by a second PSA value 4 or more weeks later.

  • Time to PSA Progression [ Time Frame: Evaluated every 28 days during Treatment Period ] [ Designated as safety issue: No ]
    In patients whose PSA has not decreased, progressive disease is a 25% increase over the baseline value and an increase in the absolute value PSA level by >=5ng/ml, confirmed by a second value at >=4 week intervals. In patients whose PSA has decreased but has not reached response criteria, progressive disease is defined as an increase in PSA by 25% over the nadir, provided that the increase is >=5ng/ml and is confirmed by a second value at >=4 week intervals.


Secondary Outcome Measures:
  • Objective Response Rate [ Time Frame: Evaluated every 12 weeks during Treatment Period ] [ Designated as safety issue: No ]
    Complete response:Complete disappearance of all clinically detectable malignant disease for at least 4 weeks.Partial Response:Definite improvement in evaluable disease estimated to be in excess of 50% and agreed upon by 2 investigators. Response must last for at least 4 weeks.Stable disease:No significant change in disease for at least 4 weeks. Includes an estimated decrease of <50% and lesions with an estimated increase of <25%.Progressive disease(PD):Definite increase in area of any malignant lesion estimated to be >=25% or appearance of new lesions. Need for radiotherapy is considered PD.

  • Overall Survival Rate [ Time Frame: Assessed every two months after completion of study treatment for 4 years ] [ Designated as safety issue: No ]
    Complete response:Complete disappearance of all clinically detectable malignant disease for at least 4 weeks.Partial Response:Definite improvement in evaluable disease estimated to be in excess of 50% and agreed upon by 2 investigators. Response must last for at least 4 weeks.Stable disease:No significant change in disease for at least 4 weeks. Includes an estimated decrease of <50% and lesions with an estimated increase of <25%.Progressive disease(PD):Definite increase in area of any malignant lesion estimated to be >=25% or appearance of new lesions. Need for radiotherapy is considered PD.


Enrollment: 58
Study Start Date: October 2002
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
Please see intervention descriptions
Drug: carboplatin
Administered Day 1 of each cycle. AUC=6.
Other Name: Paraplatin
Drug: paclitaxel
administered Days 1, 8, and 15 of each cycle. 100mg/m2
Other Name: Taxol

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Bristol-Myers Squibb
Investigators
Principal Investigator: Fairooz F. Kabbinavar, MD Jonsson Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00049257     History of Changes
Other Study ID Numbers: CDR0000258050, P30CA016042, UCLA-0202092, BMS-UCLA-020209201, NCI-G02-2121
Study First Received: November 12, 2002
Results First Received: April 28, 2011
Last Updated: August 2, 2012
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Jonsson Comprehensive Cancer Center:
adenocarcinoma of the prostate
recurrent prostate cancer
stage IV prostate cancer

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

ClinicalTrials.gov processed this record on October 02, 2014