Combination Chemotherapy in Patients With Advanced Urinary Tract Cancer - Full Text View

Purpose

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	Intervention	Phase
Bladder Cancer Urethral Cancer	Drug: cisplatin Drug: ifosfamide Drug: paclitaxel	Phase 2


Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
Official Title:	Phase II Trial of Paclitaxel, Cisplatin and Ifosfamide in Patients With Advanced Urothelial Tumors

Resource links provided by NLM:

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

Further study details as provided by Memorial Sloan Kettering Cancer Center:

Primary Outcome Measures:

Efficacy


Estimated Enrollment:	40
Study Start Date:	May 1995
Study Completion Date:	October 2007
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
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

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002684

Locations


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


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

More Information


ClinicalTrials.gov Identifier:	NCT00002684 History of Changes
Other Study ID Numbers:	95-031 CDR0000064373 ( Registry Identifier: PDQ (Physician Data Query) ) NCI-V95-0743
Study First Received:	November 1, 1999
Last Updated:	July 2, 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:


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

ClinicalTrials.gov processed this record on July 19, 2017