Completed

Phase II Trial of Neoadjuvant, Multi-Agent Chemotherapy For Locally Advanced Urothelial Cancer

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What is being tested

Data Collection

Who is being recruted

Urogenital Diseases
+18

+ Urinary Bladder Diseases
+ Urinary Bladder Neoplasms
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: July 2001
See protocol details

Summary

Principal SponsorM.D. Anderson Cancer Center
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: July 1, 2001Actual date on which the first participant was enrolled.

OBJECTIVES: Primary * Determine the response rate and 4-year disease-free survival of patients with locally advanced carcinoma of the urothelium undergoing radical cystectomy treated with neoadjuvant chemotherapy comprising ifosfamide, doxorubicin, and gemcitabine followed by cisplatin, gemcitabine, and ifosfamide. Secondary * Compare perioperative morbidity and mortality of patients treated with this regimen vs historical standards. OUTLINE: Patients receive neoadjuvant chemotherapy comprising ifosfamide IV over 3 hours on days 1-4, doxorubicin IV on day 3, gemcitabine IV over 30 minutes on days 2 and 4, and filgrastim (G-CSF) subcutaneously on days 7-12 or until blood counts recover. Treatment repeats every 3 weeks for a total of 3 courses. Patients then receive cisplatin IV, gemcitabine IV over 90 minutes, and ifosfamide IV over 30 minutes on day 1. Treatment repeats every 2 weeks for a total of 4-6 courses. Four to six weeks after the completion of all neoadjuvant chemotherapy, patients undergo cystectomy. Patients are followed at 9, 12, 15, 18, 24, and 30 months and then annually thereafter. PROJECTED ACCRUAL: A total of 31-49 patients will be accrued for this study within 16-25 months.

Official TitlePhase II Trial of Neoadjuvant, Multi-Agent Chemotherapy For Locally Advanced Urothelial Cancer 
NCT00080795
Principal SponsorM.D. Anderson Cancer Center
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
65 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Urogenital Diseases
Urinary Bladder Diseases
Urinary Bladder Neoplasms
Carcinoma
Carcinoma, Transitional Cell
Female Urogenital Diseases and Pregnancy Complications
Kidney Diseases
Kidney Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Ureteral Diseases
Ureteral Neoplasms
Urethral Diseases
Urethral Neoplasms
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Female Urogenital Diseases
Male Urogenital Diseases
Criteria

DISEASE CHARACTERISTICS: * Histologically confirmed carcinoma of the urothelium, meeting 1 of the following criteria for locally advanced disease: * Clinical stage T3b disease, defined by presence of a mass on examination under anesthesia * Clinical stage T4a disease, defined by direct invasion of prostatic stroma, vagina, or rectum * Lymphovascular invasion on transurethral resection specimen * Upper tract disease or micropapillary histology allowed * No evidence of disease outside the pelvis PATIENT CHARACTERISTICS: Age * Any age Performance status * 0-2 Life expectancy * Not specified Hematopoietic * Bone marrow function adequate Hepatic * Liver function adequate Renal * Creatinine clearance ≥ 45 mL/min Cardiovascular * Ejection fraction ≥ 50% Other * Not pregnant * No other malignancy likely to be life-threatening within the next 4 years PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * See Disease Characteristics

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives
Study Objectives
Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
M.D. Anderson Cancer Center at University of TexasHouston, United StatesSee the location
CompletedOne Study Center