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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
carboplatin
paclitaxel
Sponsored by
Jonsson Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, recurrent prostate cancer, stage IV prostate cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Jonsson Comprehensive Cancer Center at UCLA

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Please see intervention descriptions

Outcomes

Primary Outcome Measures

Prostate-specific Antigen (PSA) Response Rate
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
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
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
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.

Full Information

First Posted
November 12, 2002
Last Updated
August 17, 2020
Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00049257
Brief Title
Paclitaxel and Carboplatin in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
Official Title
A Phase II Trial of Paclitaxel and Carboplatin in the Treatment of Hormone-Refractory Prostate Cancer (HRPC)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
adenocarcinoma of the prostate, recurrent prostate cancer, stage IV prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Please see intervention descriptions
Intervention Type
Drug
Intervention Name(s)
carboplatin
Other Intervention Name(s)
Paraplatin
Intervention Description
Administered Day 1 of each cycle. AUC=6.
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Other Intervention Name(s)
Taxol
Intervention Description
administered Days 1, 8, and 15 of each cycle. 100mg/m2
Primary Outcome Measure Information:
Title
Prostate-specific Antigen (PSA) Response Rate
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.
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.
Title
Time to PSA Progression
Description
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.
Time Frame
Evaluated every 28 days during Treatment Period
Secondary Outcome Measure Information:
Title
Objective Response Rate
Description
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.
Time Frame
Evaluated every 12 weeks during Treatment Period
Title
Overall Survival Rate
Description
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.
Time Frame
Assessed every two months after completion of study treatment for 4 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fairooz F. Kabbinavar, MD
Organizational Affiliation
Jonsson Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jonsson Comprehensive Cancer Center at UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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