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Combination Chemotherapy Following Surgery in Treating Patients With Urinary Tract Cancer

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ClinicalTrials.gov Identifier: NCT00028860
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 10, 2013
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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 or disease Intervention/treatment Phase
Bladder Cancer Transitional Cell Cancer of the Renal Pelvis and Ureter Biological: filgrastim Drug: carboplatin Drug: gemcitabine hydrochloride Drug: ifosfamide Drug: paclitaxel Procedure: adjuvant therapy Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Phase II Trial Of Adjuvant Chemotherapy For High Risk Transitional Cell Carcinoma Of The Urothelium
Study Start Date : October 2001
Actual Study Completion Date : October 2004






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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00028860     History of Changes
Other Study ID Numbers: TULCC-RM-002
CDR0000069142 ( Registry Identifier: PDQ (Physician Data Query) )
AMGEN-TULCC-RM-002
BMS-TULCC-RM-002
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: July 10, 2013
Last Verified: August 2004

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

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Carcinoma, Transitional Cell
Kidney Neoplasms
Ureteral Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Diseases
Ureteral Diseases
Gemcitabine
Carboplatin
Ifosfamide
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Alkylating Agents