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COMPLETEDPHASE2

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)

NCT00049257•Jonsson Comprehensive Cancer Center

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.

Eligibility

Age

18 - No limit years

Sex

MALE

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
+6 more criteria

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
+5 more criteria

Locations (1)

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, United States

Key Dates

Start Date

October 1, 2002

Primary Completion Date

March 1, 2009

Completion Date

March 1, 2009

Last Updated

September 1, 2020

Enrollment

ACTUAL participants

Conditions

Prostate Cancer

Interventions

carboplatin

DRUG

paclitaxel

DRUG

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

NCT04550494

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RECRUITINGPHASE2

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

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Metastatic Castration-Resistant Prostate Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 1, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

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Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

PSMA-PET: Deep Radiomic Biomarkers of Progression and Response Prediction in Prostate Cancer

Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPC