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Phase II Trial of Paclitaxel, Cisplatin and Ifosfamide in Patients With Advanced Urothelial Tumors


Phase 2
18 Years
N/A
Not Enrolling
Both
Bladder Cancer, Urethral Cancer

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Trial Information

Phase II Trial of Paclitaxel, Cisplatin and Ifosfamide in Patients With Advanced Urothelial Tumors


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Efficacy

Safety Issue:

No

Principal Investigator

Dean F. Bajorin, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000064373

NCT ID:

NCT00002684

Start Date:

May 1995

Completion Date:

Related Keywords:

  • Bladder Cancer
  • Urethral Cancer
  • 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
  • Urinary Bladder Neoplasms
  • Urethral Neoplasms
  • Urologic Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021