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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

Must not have

Patients with uncontrolled CNS metastases

Patients with metastases to the bladder from a primary adenocarcinoma arising outside the urinary tract

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every 2 cycles (6 weeks)

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My brain metastases are not under control.

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My cancer started outside the urinary tract and has spread to my bladder.

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I do not have a severe illness that would stop me from completing the treatment.

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I am mentally capable of understanding and consenting to participate.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 2 cycles (6 weeks)

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Patients with Response

Secondary study objectives

Number of Patients with Dose-Limiting Toxicity

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~6010