Clinical trial NCT00002684: Combination Chemotherapy in Patients With Advanced Urinary Tract Cancer
Official title: Phase II Trial of Paclitaxel, Cisplatin and Ifosfamide in Patients With Advanced Urothelial Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bladder Cancer
Urethral Cancer
Keywords: 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
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2003-01-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Efficacy
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Dean F. Bajorin, MD
role: STUDY_CHAIR
References: