NCT00003105

Brief 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 tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy in treating patients with metastatic or locally advanced bladder cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 1997

Longer than P75 for phase_1

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

September 1, 1997

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2004

Completed
Last Updated

July 3, 2013

Status Verified

July 1, 2013

Enrollment Period

6.9 years

First QC Date

November 1, 1999

Last Update Submit

July 2, 2013

Conditions

Bladder CancerTransitional Cell Cancer of the Renal Pelvis and Ureter

Keywords

stage III bladder cancerrecurrent bladder cancerstage IV bladder cancertransitional cell carcinoma of the bladdermetastatic transitional cell cancer of the renal pelvis and ureterregional transitional cell cancer of the renal pelvis and ureterrecurrent transitional cell cancer of the renal pelvis and ureter

Interventions

filgrastimBIOLOGICAL
cisplatinDRUG
doxorubicin hydrochlorideDRUG
gemcitabine hydrochlorideDRUG
ifosfamideDRUG
paclitaxelDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed transitional cell carcinoma of the urothelium * Measurable disease, defined as unresectable or metastatic urothelial tract tumors OR * Evaluable disease, defined as T3b or T4a bladder tumors PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 70-100% Life expectancy: * Not specified Hematopoietic: * Granulocyte count greater than 1,500/mm\^3 * Platelet count greater than 150,000/mm\^3 Hepatic: * Bilirubin less than 1.5 times normal * SGOT less than 2 times normal Renal: * Creatinine less than 1.5 mg/dL OR * Creatinine clearance greater than 60 mL/min Cardiovascular: * No New York Heart Association class III or IV heart disease * No serious cardiac arrhythmias, including first, second, or third degree heart block * LVEF at least 50% Other: * No uncontrolled infection * No other active malignancy except curatively treated nonmelanomatous skin cancer or carcinoma in situ of the cervix * Fertile patients must use effective barrier contraception before, during, and for 6 months after study and are encouraged to continue for 2 years or longer after study PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior systemic chemotherapy Endocrine therapy: * Not specified Radiotherapy: * At least 3 weeks since prior radiotherapy 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)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Related Publications (1)

  • Milowsky MI, Nanus DM, Maluf FC, Mironov S, Shi W, Iasonos A, Riches J, Regazzi A, Bajorin DF. Final results of sequential doxorubicin plus gemcitabine and ifosfamide, paclitaxel, and cisplatin chemotherapy in patients with metastatic or locally advanced transitional cell carcinoma of the urothelium. J Clin Oncol. 2009 Sep 1;27(25):4062-7. doi: 10.1200/JCO.2008.21.2241. Epub 2009 Jul 27.

    PMID: 19636012RESULT

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

FilgrastimCisplatinDoxorubicinGemcitabineIfosfamidePaclitaxel

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital 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 CompoundsOxazinesTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicDiterpenesTerpenes

Study Officials

  • Dean F. Bajorin, MD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

September 1, 1997

Primary Completion

August 1, 2004

Study Completion

August 1, 2004

Last Updated

July 3, 2013

Record last verified: 2013-07

Locations

US(1)