Combination Chemotherapy in Patients With Advanced Urinary Tract Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT00002684

Recruitment Status : Completed

First Posted : January 27, 2003

Last Update Posted : July 3, 2013

Sponsor:

Information provided by:

Memorial Sloan Kettering Cancer Center

Study Description

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as cisplatin, ifosfamide, and paclitaxel, use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving drugs in different ways may kill more tumor cells.

PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating patients with metastatic urinary tract cancer that cannot be treated with surgery.

Condition or disease	Intervention/treatment	Phase
Bladder Cancer Urethral Cancer	Drug: cisplatin Drug: ifosfamide Drug: paclitaxel	Phase 2

Detailed Description:

OBJECTIVES:

Determine the efficacy of cisplatin, ifosfamide, and paclitaxel in patients with unresectable or metastatic urothelial cancer (nontransitional cell histologies).

OUTLINE: Patients receive paclitaxel IV over 3 hours and cisplatin IV over 1 hour on day 1 and ifosfamide IV over 1 hour on days 1-3. Filgrastim (G-CSF) is administered subcutaneously daily beginning on day 6 and continuing through day 17 or until blood counts recover. Treatment continues every 3 weeks for a maximum of 6 courses in the absence of stable or progressive disease after completion of course 2 or complete response after completion of course 4.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 2 years.

Study Design

Layout table for study information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	40 participants
Primary Purpose:	Treatment
Official Title:	Phase II Trial of Paclitaxel, Cisplatin and Ifosfamide in Patients With Advanced Urothelial Tumors
Study Start Date :	May 1995
Actual Primary Completion Date :	October 2007
Actual Study Completion Date :	October 2007

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Bladder cancer

Drug Information available for: Ifosfamide

Genetic and Rare Diseases Information Center resources: Urethral Cancer

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

Efficacy

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically proven unresectable or metastatic urothelial cancer
- No transitional cell histologies
Bidimensionally measurable disease

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

Karnofsky 60-100%

Hematopoietic:

WBC at least 3,500/mm^3
Platelet count greater than 150,000/mm^3

Hepatic:

Bilirubin less than 2.0 mg/dL

Renal:

Creatinine less than 1.5 mg/dL OR
Creatinine clearance greater than 55 mL/min

Cardiovascular:

No New York Heart Association class III or IV heart disease

Other:

No other concurrent malignancy except basal cell skin cancer

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

Not specified

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002684

Locations

Layout table for location information

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021

Sponsors and Collaborators

Memorial Sloan Kettering Cancer Center

Investigators

Layout table for investigator information

Study Chair:	Dean F. Bajorin, MD	Memorial Sloan Kettering Cancer Center

More Information

Layout table for additonal information

ClinicalTrials.gov Identifier:	NCT00002684 History of Changes
Other Study ID Numbers:	95-031 CDR0000064373 ( Registry Identifier: PDQ (Physician Data Query) ) NCI-V95-0743
First Posted:	January 27, 2003 Key Record Dates
Last Update Posted:	July 3, 2013
Last Verified:	July 2013

Keywords provided by Memorial Sloan Kettering Cancer Center:


stage III bladder cancer recurrent bladder cancer stage IV bladder cancer squamous cell carcinoma of the bladder adenocarcinoma of the bladder	recurrent urethral cancer distal urethral cancer proximal urethral cancer urethral cancer associated with invasive bladder cancer

Additional relevant MeSH terms:

Layout table for MeSH terms

Urinary Bladder Neoplasms Urethral Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplasms Urinary Bladder Diseases Urologic Diseases Urethral Diseases Paclitaxel Albumin-Bound Paclitaxel	Cisplatin Ifosfamide Isophosphamide mustard Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Alkylating Alkylating Agents

To Top