Prostate CancerPhase 2NCT00049257

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

A Phase 2 study testing carboplatin and paclitaxel in people with Prostate Cancer, run by Jonsson Comprehensive Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Prostate Cancer
What is being tested?: carboplatin and paclitaxel
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 58 participants
Where: 1 siteUnited States
Study dates: Oct 2002to Mar 2009
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

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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

Who cannot join

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

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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

Trial locations and contacts

1 site in 1 country.

United States1 site

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

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions: Prostate Cancer
Being tested: carboplatin, paclitaxel
Keywords: adenocarcinoma of the prostate, recurrent prostate cancer, stage IV prostate cancer
Medical subject headings: Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

carboplatinDrug
Also called Paraplatin
Administered Day 1 of each cycle. AUC=6.
paclitaxelDrug
Also called Taxol
administered Days 1, 8, and 15 of each cycle. 100mg/m2

Study groups in NCT00049257
Study group	Role	What they receive
Treatment	Experimental	Please see intervention descriptions Receives: Drug: carboplatin; Drug: paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
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.
Measured: Evaluated every 28 days during Treatment Period

Secondary outcomes (2)

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.
Measured: Evaluated every 12 weeks during Treatment Period
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.
Measured: Assessed every two months after completion of study treatment for 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2002Mar 2009

First posted27 Jan 2003 (estimated)
Study startOct 2002
Primary completionMar 2009
Study completionMar 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Prostate CancerStudies of the same condition, open and under way.
More trials run by Jonsson Comprehensive Cancer CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 58 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00049257
Sponsor's protocol ID: CDR0000258050
Other IDs: UCLA-0202092, BMS-UCLA-020209201, NCI-G02-2121
Status last verified: Aug 2012
First submitted: 12 Nov 2002
Last updated: 1 Sep 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 1 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II Trial of Paclitaxel and Carboplatin in the Treatment of Hormone-Refractory Prostate Cancer (HRPC)
ClinicalTrials.gov ID: NCT00049257
Acronym / sponsor ID: CDR0000258050
Conditions: Prostate Cancer
Keywords: adenocarcinoma of the prostate, recurrent prostate cancer, stage IV prostate cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 58 participants (actual)
Lead sponsor: Jonsson Comprehensive Cancer CenterUniversity, hospital or other
Collaborators: Bristol-Myers Squibb
Study start: Oct 2002
Primary completion: Mar 2009 (actual)
Study completion: Mar 2009 (actual)
First posted: 27 Jan 2003 (estimated)
Results: Posted 15 Mar 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment	Experimental	Drug: carboplatin, Drug: paclitaxelPlease see intervention descriptions

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

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

Key exclusion criteria (15 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
carboplatinAlso: ParaplatinAdministered Day 1 of each cycle. AUC=6.	Drug	Treatment
paclitaxelAlso: Taxoladministered Days 1, 8, and 15 of each cycle. 100mg/m2	Drug	Treatment

Primary outcome

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.
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
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.

2 secondary outcomes

Objective Response Rate
Time frame: Evaluated every 12 weeks during Treatment Period
Overall Survival Rate
Time frame: Assessed every two months after completion of study treatment for 4 years

Results and safety

Results posted to the registry on 15 Mar 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Carboplatin, Paclitaxel	58	45

Primary outcome: 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.. Number. Unit: participants

Measure	Carboplatin, Paclitaxel n = 58
Participants with PSA response	28
Participants with no PSA response	30

Primary outcome: Time to PSA Progression

Time frame: Evaluated every 28 days during Treatment Period. Median (Full Range). Unit: days

Measure	Carboplatin, Paclitaxel n = 58
Value	115 (26 to 394)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Carboplatin, Paclitaxel	14 of 58 (24.1%)	58 of ?	Not reported

Limitations and caveats (from the sponsor): The major weakness of the study is, it is a single-arm non-comparative study. With the small sample size of 58 participants who received treatment, the study does not have the statistical power to make categorical assessments or statements.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Fairooz F. Kabbinavar, MD principal investigator

Jonsson Comprehensive Cancer Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing carboplatin and paclitaxel in people with Prostate Cancer, run by Jonsson Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00049257.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2020.