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Combination Chemotherapy Following Surgery in Treating Patients With Urinary Tract Cancer

Primary Purpose

Bladder Cancer, Transitional Cell Cancer of the Renal Pelvis and Ureter

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
filgrastim
carboplatin
gemcitabine hydrochloride
ifosfamide
paclitaxel
adjuvant therapy
Sponsored by
Tulane University Health Sciences Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring 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

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tulane Cancer Center at Tulane University Hospital and Clinic

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 4, 2002
Last Updated
July 9, 2013
Sponsor
Tulane University Health Sciences Center
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1. Study Identification

Unique Protocol Identification Number
NCT00028860
Brief Title
Combination Chemotherapy Following Surgery in Treating Patients With Urinary Tract Cancer
Official Title
A Phase II Trial Of Adjuvant Chemotherapy For High Risk Transitional Cell Carcinoma Of The Urothelium
Study Type
Interventional

2. Study Status

Record Verification Date
August 2004
Overall Recruitment Status
Completed
Study Start Date
October 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Tulane University Health Sciences Center

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer, Transitional Cell Cancer of the Renal Pelvis and Ureter
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
filgrastim
Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Intervention Type
Drug
Intervention Name(s)
ifosfamide
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raja Mudad, MD, FACP
Organizational Affiliation
Tulane University Health Sciences Center
Official's Role
Study Chair
Facility Information:
Facility Name
Tulane Cancer Center at Tulane University Hospital and Clinic
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States

12. IPD Sharing Statement

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Combination Chemotherapy Following Surgery in Treating Patients With Urinary Tract Cancer

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