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Alkylating agents

Combination Chemotherapy for Prostate Cancer

Phase 2
Waitlist Available
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Performance status: Karnofsky 60-100% ECOG 0-2
No concurrent antiandrogen therapy withdrawal: Must continue antiandrogen therapy until completion of study OR Must discontinue flutamide at least 4 weeks before or bicalutamide at least 8 weeks before study enrollment, and must have disease progression off antiandrogen therapy, defined by serial increase in PSA (at least 2 measurements taken at least 2 weeks apart) or measurable tumor
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial is studying how well giving combination chemotherapy helps to treat patients with prostate cancer that has not responded to hormone therapy.

Who is the study for?
Men with prostate cancer that hasn't improved with hormone therapy can join this trial. They need to have a type of cancer called adenocarcinoma, which hasn't been treated with chemo yet. Their disease must be getting worse despite antiandrogen therapy, and they should not have other serious health issues or another cancer in the last 5 years. Participants must be adults expected to live at least another 6 months.Check my eligibility
What is being tested?
The study is testing how well different chemotherapy drugs work together on patients whose prostate cancer didn’t respond to hormone treatment. It's a Phase II trial, meaning it focuses on the effectiveness of this combination chemotherapy approach.See study design
What are the potential side effects?
Chemotherapy can cause side effects like fatigue, nausea, hair loss, increased risk of infection due to low blood cell counts, and potential damage to organs such as the heart or liver depending on individual health conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can care for myself but may not be able to do active work.
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I have stopped or will continue antiandrogen therapy as required, with disease progression confirmed.
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My prostate cancer has not responded to hormone therapy and I haven't had chemotherapy.
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My creatinine level is 2.0 mg/dL or lower.
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I do not have any active infections and I am HIV negative.
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My heart function is normal and I have no history of severe heart disease.
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I am not allergic to E. coli proteins or drugs with polysorbate 80.
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My liver tests are within the required range.
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My cancer can be measured or seen on tests.
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I am 18 years old or older.

Timeline

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

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor
1,371 Previous Clinical Trials
1,378,218 Total Patients Enrolled
12 Trials studying Prostate Cancer
4,844 Patients Enrolled for Prostate Cancer
Debra Litwak, PharmDStudy ChairAmgen

Media Library

Cyclophosphamide (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT00005960 — Phase 2
Prostate Cancer Research Study Groups:
Prostate Cancer Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT00005960 — Phase 2
Cyclophosphamide (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00005960 — Phase 2

Frequently Asked Questions

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

Is this intervention safe for those being treated?

"This treatment option has been allocated a safety rating of 2, given the current Phase 2 status which implies that there is some evidence for its security, however none to back up efficacy."

Answered by AI

How many facilities are monitoring this experiment?

"Currently, this medical trial is being operated in 6 distinct locations spread across the country. Hickory, Los Angeles and Great Neck are among them. To limit travel requirements when participating, it is essential to pick a clinic near you."

Answered by AI

Are there currently any vacancies for participation in this medical trial?

"According to clinicaltrials.gov, this study is no longer actively recruiting participants. It was initially published on October 1st 1999 and the last update was December 3rd 2013. Despite this trial's inactivity, there are currently 1653 other medical studies that still need patients' participation."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
New York Medical College
What portion of applicants met pre-screening criteria?
Did not meet criteria
~14 spots leftby Apr 2025