NCT00080795

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as ifosfamide, doxorubicin, gemcitabine, and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug, and giving them before surgery, may shrink the tumor so that it can be removed. PURPOSE: This phase II trial is studying how well neoadjuvant combination chemotherapy works in treating patients undergoing radical cystectomy for locally advanced carcinoma of the urothelium.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2001

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2001

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

April 7, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 8, 2004

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

October 22, 2012

Status Verified

October 1, 2012

Enrollment Period

4.8 years

First QC Date

April 7, 2004

Last Update Submit

October 18, 2012

Conditions

Bladder CancerTransitional Cell Cancer of the Renal Pelvis and UreterUrethral Cancer

Keywords

stage III bladder cancerregional transitional cell cancer of the renal pelvis and ureteranterior urethral cancerposterior urethral cancerurethral cancer associated with invasive bladder cancer

Outcome Measures

Primary Outcomes (2)

  • Response rate

    6 weeks following treatment

  • Disease-free survival at 4 years

    4 years

Secondary Outcomes (1)

  • Comparison of perioperative treatment morbidity and mortality with historical standards

    Minimally reviewed following 6 weeks post treatment

Interventions

filgrastimBIOLOGICAL
cisplatinDRUG
doxorubicin hydrochlorideDRUG
gemcitabine hydrochlorideDRUG
ifosfamideDRUG
conventional surgeryPROCEDURE
neoadjuvant therapyPROCEDURE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

M.D. Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009, United States

Location

MeSH Terms

Conditions

Urinary Bladder NeoplasmsUrethral Neoplasms

Interventions

FilgrastimCisplatinDoxorubicinGemcitabineIfosfamideNeoadjuvant Therapy

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesUrethral Diseases

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingCyclophosphamidePhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhosphoramidesOrganophosphorus CompoundsOxazinesCombined Modality TherapyTherapeutics

Study Officials

  • Randall E. Millikan, MD, PhD

    M.D. Anderson Cancer Center

    STUDY CHAIR

  • Colin P. Dinney, MD

    M.D. Anderson Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2004

First Posted

April 8, 2004

Study Start

July 1, 2001

Primary Completion

May 1, 2006

Study Completion

May 1, 2006

Last Updated

October 22, 2012

Record last verified: 2012-10

Locations

US(1)