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Bi-Weekly Administration of Docetaxel for Older Men With Hormone Refractory Prostate Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Bi-Weekly Administration of Docetaxel for Older Men With Hormone Refractory Prostate Cancer

A Pilot Study of Docetaxel on a Bi-Weekly Schedule in the Treatment of Elderly Men With Hormone-Refractory Prostate Cancer (HRPC)

NCT00215709•Geriatric Oncology Consortium

View on ClinicalTrials.gov

Summary

This pilot study is designed to determine the feasibility and safety of administering docetaxel at various dosing levels on a bi-weekly schedule in older men with hormone refractory prostate cancer.

Detailed Description

The information obtained from this trial will help determine the feasibility and safety of administering docetaxel at various dosing levels on a bi-weekly schedule in this patient population. If the data from this phase I trial are encouraging, a phase II trial will be conducted to further assess the efficacy of this dosing schedule.

Eligibility

Age

65 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•age ≥ 65 years;
•histologically confirmed adenocarcinoma of the prostate;
•metastatic disease;
•unresponsive or refractory to hormonal therapy, as defined by at least 1 of the following criteria: progression of bidimensionally measurable disease; progression of evaluable but not measurable disease (bone scan); at least 2 consecutive rises in PSA at least 1 week apart;
•patients must have serum testosterone levels \< 50 ng/mL at time of study entry. For patients who are medically castrated, lutenizing hormone releasing hormone analog must continue to maintain testicular suppression;
•prior nonsteroidal antiandrogens (flutamide, ketoconazole, bicalutamide, or nilutamide) allowed if disease progression occurred. No evidence of response after antiandrogen withdrawal within 4 weeks for patients treated with flutamide, ketoconazole, nilutamide and 6 weeks for patients treated with bicalutamide;
•chemotherapy naïve;
•full recovery from the effects of any prior surgery or radiation therapy. At least 4 weeks since any radiation therapy;
•ECOG performance status 0-2;
•adequate kidney, liver, and bone marrow functions;
+1 more criteria

Exclusion Criteria

•Concurrent chemotherapy or immunotherapy;
•Patients who have received an investigational drug within 4 weeks of registration;
•Prior or concurrent malignancies (other than surgically treated carcinoma in situ of the cervix and squamous or basal cell carcinoma of the skin) within the preceding five years;
•Serious medical or psychiatric illness which would prevent informed consent;
•Life expectancy \< 3 months;
•Active uncontrolled bacterial, viral, or fungal infection until these conditions are corrected or controlled;
•Known hypersensitivity to study drug or to other drugs formulated with polysorbate 80.

Locations (1)

Baltimore, Maryland, United States

Key Dates

Start Date

July 1, 2004

Completion Date

July 1, 2007

Last Updated

November 19, 2007

Enrollment

ACTUAL participants

Conditions

Prostate Cancer

Interventions

docetaxel

DRUG

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

NCT04550494

Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8+29 more

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RECRUITINGPHASE2

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

NCT06842498

Metastatic Castration-Resistant Prostate Cancer

View study

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: November 19, 2007Data 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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Bi-Weekly Administration of Docetaxel for Older Men With Hormone Refractory Prostate Cancer

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)

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

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