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Alkylating agents

Paclitaxel + Estramustine for Prostate Cancer

Phase 2

Waitlist Available

Research Sponsored by St. Barnabas Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least 4 weeks since prior antiandrogen therapy with at least 2 rises in PSA levels

At least 4 weeks since prior radiotherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is studying how well paclitaxel and estramustine work in treating patients with metastatic prostate cancer that has not responded to hormone therapy.

Who is the study for?

This trial is for men with metastatic prostate cancer that hasn't improved with hormone therapy. Participants must have a rising PSA level, confirmed metastatic disease, and no other active cancers in the last 5 years. They should have adequate kidney, liver, and blood function and a life expectancy allowing participation.Check my eligibility

What is being tested?

The study is testing the combination of two chemotherapy drugs: paclitaxel and estramustine. The goal is to see if this combo is more effective in patients whose prostate cancer has spread and isn't responding to hormone treatments anymore.See study design

What are the potential side effects?

Chemotherapy drugs like paclitaxel and estramustine can cause side effects including nausea, hair loss, fatigue, increased risk of infection due to low blood cell counts, nerve damage leading to numbness or tingling sensations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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It's been over 4 weeks since my last antiandrogen therapy, and my PSA levels have risen twice.

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It has been over 4 weeks since my last radiation treatment.

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I have never been treated with taxanes.

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I can take care of myself and am up and about more than 50% of my waking hours.

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My prostate cancer has spread, doesn't respond to hormone therapy, and my PSA is rising or above 8.

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My cancer progressed despite hormone therapy for prostate cancer.

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I haven't had any cancer except for skin cancer or localized cancer in the last 5 years.

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It has been over 4 weeks since my last chemotherapy session.

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I have never been treated with estramustine.

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I have had only one chemotherapy treatment before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

St. Barnabas Medical CenterLead Sponsor

12 Previous Clinical Trials

2,915 Total Patients Enrolled

Stuart P. Leitner, MDStudy ChairSt. Barnabas Medical Center

Media Library

Estramustine (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT00003717 — Phase 2

Prostate Cancer Clinical Trial 2023: Estramustine Highlights & Side Effects. Trial Name: NCT00003717 — Phase 2

Estramustine (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00003717 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment for the study still ongoing?

"External data from clinicaltrials.gov indicates that this investigation is not currently admitting patients, despite having been initially listed on October 1st 1998 and last amended on December 18th 2013. That said, there are 1321 alternative trials actively enrolling at the moment."

Answered by AI

Has this therapeutic intervention received regulatory authorization?

"As it is a Phase 2 trial, our team at Power assessed the safety of this treatment to be a 2, as there are some data points that allude to its security, but none providing evidence for efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Paclitaxel Plus Estramustine in Treating Patients With Metastatic Prostate Cancer

1998. "Paclitaxel Plus Estramustine in Treating Patients With Metastatic Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00003717.

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