CompletedPhase 2

Combination Chemotherapy in Treating Patients With Advanced Cancer of the Urothelium and Decreased Kidney Function

United StatesStarted 2001-01-02

Plain-language summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have advanced cancer of the urothelium with decreased kidney function.

Who can participate

Age range

18 Years – 120 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

DISEASE CHARACTERISTICS: * Histologically confirmed progressive regional or metastatic transitional cell carcinoma of the urothelium * Mixed histologies containing a component of transitional cell carcinoma allowed * Bidimensionally measurable disease * No clinical evidence of CNS metastases * Clinically unsuspected organ-confined prostate cancer found at time of cystoprostatectomy allowed PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 mg/dL * SGOT no greater than 2.5 times upper limit of normal (ULN) and alkaline phosphatase normal OR * Alkaline phosphatase no greater than 4 times ULN and SGOT normal OR * SGOT less than 1.5 times ULN and alkaline phosphatase less than 2.5 times ULN Renal: * Creatinine no greater than 3.0 mg/dL * Glomerular filtration rate no greater than 50 mL/min Cardiovascular: * No history of American Heart Association class III or IV heart disease * No uncontrolled congestive heart failure * No severe cardiac arrhythmias Other: * Not pregnant or nursing * Fertile patients must use effective contraception * No preexisting peripheral neuropathy grade 2 or greater * No active unresolved infection requiring parenteral antibiotics within the past 7 days * No other malignancy within the past 5 years except curatively treated basal cell o…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

Trial details

NCT IDNCT00005644

SponsorEastern Cooperative Oncology Group

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2003-02

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