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Mitotic Inhibitor

Chemotherapy + Filgrastim for Bladder 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
Histologically proven locally recurrent or advanced transitional cell carcinoma (TCC) of the urothelial tract (bladder, renal pelvis, or ureter) or TCC with squamous cell or glandular elements not amenable to curative treatment
Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN), SGOT no greater than 3 times ULN
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial is studying how well combination chemotherapy with gemcitabine and docetaxel works when given with filgrastim in treating patients with urothelium cancer.

Who is the study for?
This trial is for adults over 18 with locally recurrent or advanced urothelium cancer, including bladder and kidney tumors. Participants must have a good performance status (able to carry out normal activities), no active infections, no recent other cancers except certain treated stages or early prostate cancer, not be pregnant/nursing, and willing to use contraception. They cannot have brain metastases or prior treatment with the study drugs.Check my eligibility
What is being tested?
The effectiveness of combination chemotherapy using gemcitabine and docetaxel plus filgrastim is being tested in this Phase II trial. Filgrastim may help boost the immune system after chemotherapy side effects. The goal is to see how well these drugs work together in treating patients with advanced urothelial cancer.See study design
What are the potential side effects?
Potential side effects include reactions related to immune system stimulation by filgrastim such as bone pain and fever; typical chemotherapy-related issues like nausea, fatigue, hair loss; blood disorders from low white cell counts increasing infection risk; liver function changes; and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is a type of bladder cancer that cannot be cured with surgery or radiation.
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My liver function tests are within the required limits.
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My blood counts meet the required levels and I don't have a bleeding disorder.
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My cancer has not spread to my brain.
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I am over 18 years old.
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My cancer has spread after bladder and prostate removal surgery.
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I am mostly independent and active.
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My creatinine level is 2.0 mg/dL or lower.

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
1,359 Previous Clinical Trials
1,384,511 Total Patients Enrolled
Jennifer TamStudy ChairAmgen

Media Library

Docetaxel (Mitotic Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT00005958 — Phase 2
Transitional Cell Carcinoma Research Study Groups:
Transitional Cell Carcinoma Clinical Trial 2023: Docetaxel Highlights & Side Effects. Trial Name: NCT00005958 — Phase 2
Docetaxel (Mitotic Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00005958 — Phase 2

Frequently Asked Questions

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

Are volunteers still being accepted for this research project?

"Unfortunately, this particular clinical trial is not currently looking for new participants. This information can be found on clinicaltrials.gov, which also indicates that the last update to this study was on December 3rd, 2013. Although this study is no longer active, there are 635 other trials that are still recruiting patients."

Answered by AI

Has this medication been cleared for general use by the FDA?

"This particular Phase 2 trial lacks evidence of efficacy, but there is some data supporting the safety of the proposed treatment. Consequently, our team at Power rated this a 2."

Answered by AI

Is this study taking place at many different locations throughout the United States?

"Currently, this trial is underway at 13 total locations. These are: Center for Hematology-Oncology in Boca Raton, Florida; St. Joseph Medical Center in Towson, Maryland; Memphis Cancer Center, Inc. in Memphis, Tennessee; and 10 other sites."

Answered by AI
~14 spots leftby Mar 2025