Combination Chemotherapy in Patients With Advanced Urinary Tract Cancer

Study Description

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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

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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

Arms and Interventions

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Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Efficacy

Eligibility Criteria

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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

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted:	January 27, 2003
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:

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