Combination Chemotherapy Following Surgery in Treating Patients With Urinary Tract Cancer

NCT ID: NCT00028860

Last Updated: 2013-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-10-31
• Study Completion Date: 2004-10-31

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.

Conditions

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

Study Design

• Primary Study Purpose: TREATMENT

Interventions

filgrastim

Intervention Type: BIOLOGICAL

carboplatin

Intervention Type: DRUG

gemcitabine hydrochloride

Intervention Type: DRUG

ifosfamide

Intervention Type: DRUG

paclitaxel

Intervention Type: DRUG

adjuvant therapy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tulane University Health Sciences Center

OTHER

Sponsor Role: lead

Principal Investigators

Raja Mudad, MD, FACP

Role: STUDY_CHAIR

Tulane University Health Sciences Center

Locations

Tulane Cancer Center at Tulane University Hospital and Clinic

New Orleans, Louisiana, United States

Countries

United States

Other Identifiers

CDR0000069142

Identifier Type: REGISTRY

Identifier Source: secondary_id

AMGEN-TULCC-RM-002

Identifier Type: -

Identifier Source: secondary_id

BMS-TULCC-RM-002

Identifier Type: -

Identifier Source: secondary_id

TULCC-RM-002

Identifier Type: -

Identifier Source: org_study_id