Clinical trial NCT00028860: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: 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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-01-27
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Tulane Cancer Center at Tulane University Hospital and Clinic
state: Louisiana
Study officials:
affiliation: Tulane University Health Sciences Center
name: Raja Mudad, MD, FACP
role: STUDY_CHAIR
References: