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Anti-metabolites

Chemotherapy Combination for Bladder Cancer

Phase 2
Waitlist Available
Led By Arlene Siefker-Radtke, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Bi-dimensionally measurable disease with specific size criteria for liver, lung, node-only disease, and bone involvement
Patients with a history of cardiac disease must have adequate cardiac function
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 2 cycles (6 weeks)
Awards & highlights

Study Summary

This trial is studying a combination of drugs as a possible treatment for adenocarcinoma of the urothelium or urachal remnant.

Who is the study for?
This trial is for adults with advanced or inoperable adenocarcinoma of the urothelium or urachal remnant, who understand the study's experimental nature. They should have a life expectancy over 9 months, decent physical function (Zubrod PS ≤2), and adequate organ function. Pregnant women, those with mental disabilities unable to consent, uncontrolled brain metastases, or other life-threatening illnesses are excluded.Check my eligibility
What is being tested?
The trial tests a combination chemotherapy regimen using fluorouracil (5-FU), leucovorin, gemcitabine, and cisplatin on patients with metastatic or unresectable bladder-related cancers. It aims to see how well these drugs work together to stop cancer cells from growing by attacking them in different ways.See study design
What are the potential side effects?
Potential side effects include nausea and vomiting; mouth sores; low blood cell counts leading to increased infection risk, bleeding problems, fatigue; kidney damage; nerve damage causing numbness or tingling; hearing loss due to Cisplatin.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer can be measured in two ways and meets size requirements.
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My heart is functioning well despite my history of heart issues.
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I am 18 years old or older.
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My cancer, which is mostly adenocarcinoma, started in the urinary tract.
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My cancer has spread or cannot be removed with surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 2 cycles (6 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 2 cycles (6 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Patients with Response
Secondary outcome measures
Number of Patients with Dose-Limiting Toxicity

Trial Design

1Treatment groups
Experimental Treatment
Group I: 5-FU, Leucovorin, Gemcitabine + CisplatinExperimental Treatment4 Interventions
5-FU continuous infusion over Days 1 - 5; Leucovorin once a day as a short infusion on Days 1 - 5; Cisplatin infusion over a few hours (usually 2-4 hours) once a day on Days 1 - 5; Gemcitabine infusion over 30 minutes on Days 1 & 5 only.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
5-Fluorouracil (5-FU)
2003
Completed Phase 3
~5560
Leucovorin
2005
Completed Phase 4
~5730
Gemcitabine
2017
Completed Phase 3
~2070
Cisplatin
2013
Completed Phase 3
~1940

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,600 Total Patients Enrolled
20 Trials studying Urethral Cancer
2,125 Patients Enrolled for Urethral Cancer
M.D. Anderson Cancer CenterLead Sponsor
2,958 Previous Clinical Trials
1,798,403 Total Patients Enrolled
3 Trials studying Urethral Cancer
178 Patients Enrolled for Urethral Cancer
Arlene Siefker-Radtke, MDPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
232 Total Patients Enrolled
1 Trials studying Urethral Cancer
80 Patients Enrolled for Urethral Cancer

Media Library

5-Fluorouracil (5-FU) (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT00082706 — Phase 2
Urethral Cancer Research Study Groups: 5-FU, Leucovorin, Gemcitabine + Cisplatin
Urethral Cancer Clinical Trial 2023: 5-Fluorouracil (5-FU) Highlights & Side Effects. Trial Name: NCT00082706 — Phase 2
5-Fluorouracil (5-FU) (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00082706 — Phase 2

Frequently Asked Questions

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

What are the most common Gemcitabine side effects that patients experience?

"While there is some evidence that gemcitabine is safe, it did not receive a higher score because this drug is still in Phase 2 clinical trials. This means that, while there are animal studies and small human trials supporting safety, large-scale efficacy has yet to be proven."

Answered by AI

For what purpose is Gemcitabine most often leveraged?

"Gemcitabine has been shown to be an effective treatment against malignant neoplasms of the pancreas, urinary bladder, and neoplasm metastasis."

Answered by AI

What is the target sample size for this research?

"This study has wrapped up its participant recruitment. However, if you're still interested in other trials, there are 1176 and 1305 respectively for cancer of the urethra and Gemcitabine that are ongoing."

Answered by AI

Are patients able to enroll in this clinical trial at this time?

"This study is no longer recruiting patients. According to the clinical trial information first posted on April 1st, 2003 and last edited on October 20th, 2022, this study has ended. However, there are 1176 other studies involving cancer of the urethra that are actively recruiting participants and 1305 trials for Gemcitabine currently admitting patients."

Answered by AI
~2 spots leftby Dec 2024