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Combination Chemotherapy Following Surgery in Treating Patients With Urinary Tract Cancer
This study has been completed.
Sponsored by: Tulane University Health Sciences Center
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00028860
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy following surgery in treating patients who have urinary tract cancer.


Condition Intervention Phase
Bladder Cancer
Transitional Cell Cancer of the Renal Pelvis and Ureter
Drug: carboplatin
Drug: filgrastim
Drug: gemcitabine hydrochloride
Drug: ifosfamide
Drug: paclitaxel
Procedure: adjuvant therapy
Phase II

Genetics Home Reference related topics: bladder cancer
MedlinePlus related topics: Bladder Cancer Cancer
Drug Information available for: Ifosfamide Carboplatin Filgrastim Gemcitabine hydrochloride Gemcitabine Paclitaxel
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: A Phase II Trial Of Adjuvant Chemotherapy For High Risk Transitional Cell Carcinoma Of The Urothelium

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: October 2001
Detailed Description:

OBJECTIVES:

  • Determine the time to treatment failure and disease-free survival in patients with high-risk transitional cell carcinoma of the urothelium treated with adjuvant paclitaxel, ifosfamide, carboplatin, and gemcitabine.
  • Determine the tolerability and feasibility of this regimen in these patients.

OUTLINE: Patients are stratified according to disease stage.

Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 1 hour on day 1, ifosfamide IV over 1 hour on days 1-3, and filgrastim (G-CSF) subcutaneously (SC) once daily beginning on day 4 and continuing until blood counts recover. Treatment repeats every 21 days for a total of 2 courses.

Beginning 3 weeks after the completion of the second course of chemotherapy, patients receive gemcitabine IV over 30 minutes on days 1 and 8 and carboplatin IV over 1 hour on day 1. Patients also receive G-CSF SC once daily on days 2-6 and again beginning on day 9 and continuing until blood counts recover. Treatment repeats every 21 days for a total of 2 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed at 3 months, every 6 months for 2 years, and then annually for 3 years.

PROJECTED ACCRUAL: A total of 10-30 patients will be accrued for this study.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of transitional cell carcinoma of the urothelium including bladder, ureter, and renal pelvis

    • T3b-4, N0, M0 OR
    • Any T, N1-3, M0
  • Cystectomy within the past 8 weeks

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Performance status:

  • ECOG 0-1

Life expectancy:

  • At least 12 months

Hematopoietic:

  • Absolute granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • AST or ALT no greater than 2.5 times ULN

Renal:

  • Creatinine no greater than ULN
  • Albumin no greater than ULN

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other prior malignancy except curatively treated carcinoma in situ of the cervix or non-melanoma skin cancer
  • No active serious infection, other serious underlying medical condition, dementia, or significantly altered mental status that would preclude study participation
  • No known hypersensitivity to Cremophor EL
  • No pre-existing clinically significant grade 2 or greater neuropathy
  • No AIDS (HIV positivity alone allowed)
  • No known hypersensitivity to E. coli-derived products

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy for malignancy
  • No neoadjuvant chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior radiotherapy for malignancy

Surgery:

  • See Disease Characteristics

Other:

  • No other concurrent investigational therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00028860

Locations
United States, Louisiana
Tulane Cancer Center at Tulane University Hospital and Clinic
New Orleans, Louisiana, United States, 70112
Sponsors and Collaborators
Tulane University Health Sciences Center
Investigators
Study Chair: Raja Mudad, MD, FACP Tulane University Health Sciences Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000069142, TULCC-RM-002, AMGEN-TULCC-RM-002, BMS-TULCC-RM-002
Study First Received: January 4, 2002
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00028860  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III bladder cancer
stage IV bladder cancer
transitional cell carcinoma of the bladder
localized transitional cell cancer of the renal pelvis and ureter
regional transitional cell cancer of the renal pelvis and ureter

Study placed in the following topic categories:
Cystocele
Urinary Bladder Diseases
Urinary Bladder Neoplasms
Ureteral Diseases
Urogenital Neoplasms
Carboplatin
Renal cancer
Kidney cancer
Carcinoma, Transitional Cell
Urologic Neoplasms
Transitional cell carcinoma
Carcinoma
Ifosfamide
Urologic Diseases
Paclitaxel
Kidney Neoplasms
Kidney Diseases
Gemcitabine
Ureteral Neoplasms
Urinary tract neoplasm
Isophosphamide mustard
Bladder neoplasm
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Physiological Effects of Drugs
Enzyme Inhibitors
Antimitotic Agents
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Phytogenic
Alkylating Agents

ClinicalTrials.gov processed this record on January 16, 2009