Combination Chemotherapy Following Surgery in Treating Patients With Urinary Tract Cancer

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

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.

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 Design

• 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

Arms and Interventions

Outcome Measures

Eligibility Criteria

• 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

Contacts and Locations

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

• ClinicalTrials.gov Identifier: NCT00028860
• 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
• 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; Paclitaxel; Carboplatin; Ifosfamide; Antineoplastic Agents, Phytogenic; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antiviral Agents; Anti-Infective Agents; Enzyme Inhibitors