Randomized Phase II/III Study Assessing Gemcitabine/Carboplatin And Methotrexate/Carboplatin/Vinblastine In Previously Untreated Patients With Advanced Urothelial Cancer Ineligible For Cisplatin Based Chemotherapy
18 Years
N/A
Both
Bladder Cancer, Transitional Cell Cancer of the Renal Pelvis and Ureter, Urethral Cancer
Trial Information
Randomized Phase II/III Study Assessing Gemcitabine/Carboplatin And Methotrexate/Carboplatin/Vinblastine In Previously Untreated Patients With Advanced Urothelial Cancer Ineligible For Cisplatin Based Chemotherapy
OBJECTIVES:
- Compare the antitumor activity of gemcitabine and carboplatin vs methotrexate,
carboplatin, and vinblastine in patients with transitional cell cancer of the
urothelium who are ineligible for cisplatin-based chemotherapy.
- Compare the toxicity and acute and intermediate (1-2 years) side effects of these
regimens in these patients.
- Compare the complete response rates, progression-free survival, and overall survival of
patients treated with these regimens.
- Compare the symptoms and quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two
treatment arms.
- Arm I: Patients receive methotrexate* IV and vinblastine IV on days 1, 15, and 22 and
carboplatin IV over 1 hour on day 1. Courses repeat every 28 days in the absence of
disease progression or unacceptable toxicity.
- Arm II: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and carboplatin
IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease
progression or unacceptable toxicity.
NOTE: * Methotrexate is omitted for patients with pleural effusion or ascites until complete
resolution and for patients with a glomerular filtration rate less than 30 mL/min or
creatinine greater than 2 mg/dL
Patients in either arm who achieve a complete response (CR) receive 2 additional courses of
chemotherapy beyond CR.
Quality of life is assessed at baseline, after every 2 courses of chemotherapy, and within 6
weeks of completion of therapy.
Patients are followed within 6 weeks, every 3 months for 1 year, and then every 6 months
thereafter.
PROJECTED ACCRUAL: A total of 156 patients (78 per treatment arm) will be accrued for the
phase II portion of this study. A total of 225 patients will be accrued for the phase II +
III portions of this study within 5 years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed transitional cell cancer of the urothelium, including the
renal pelvis, ureters, urinary bladder, and urethra, meeting 1 of the following
criteria:
- Unresected positive lymph node
- Distant metastases (M1, stage IV)
- Unresectable primary bladder cancer (T3-4)
- Measurable disease
- Ineligible for cisplatin-based chemotherapy and presenting with the following:
- WHO performance status 2 AND/OR
- Glomerular filtration rate greater than 30 mL/min but less than 60 mL/min
- No brain metastases or other CNS lesions
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- See Disease Characteristics
Life expectancy:
- Not specified
Hematopoietic:
- WBC at least 4,000/mm^3
- Platelet count at least 125,000/mm^3
Hepatic:
- Bilirubin no greater than 1.25 times normal
- AST/ALT no greater than 3 times normal (5 times normal if liver metastases are
present)
Renal:
- See Disease Characteristics
- Calcium normal
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 6 months after study
participation
- No psychological, familial, sociological, or geographical condition that would
preclude study participation
- No other prior or concurrent malignancy except cured basal cell skin cancer or
carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior systemic biologic therapy
Chemotherapy:
- See Disease Characteristics
- No prior systemic cytotoxic therapy (including adjuvant and neoadjuvant chemotherapy)
Endocrine therapy:
- Not specified
Radiotherapy:
- At least 3 months since prior radiotherapy
- Prior radiotherapy to study lesions allowed if there is evidence of disease
progression
Surgery:
- Not specified
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Outcome Measure:
Duration of survival
Safety Issue:
No
Principal Investigator
Gerwin Kaiser, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Klinikum Nuernberg - Klinikum Nord
Authority:
United States: Federal Government
Study ID:
EORTC-30986
NCT ID:
NCT00014274
Start Date:
January 2001
Completion Date:
Related Keywords:
- Bladder Cancer
- Transitional Cell Cancer of the Renal Pelvis and Ureter
- Urethral Cancer
- stage III bladder cancer
- stage IV bladder cancer
- transitional cell carcinoma of the bladder
- anterior urethral cancer
- posterior urethral cancer
- urethral cancer associated with invasive bladder cancer
- metastatic transitional cell cancer of the renal pelvis and ureter
- regional transitional cell cancer of the renal pelvis and ureter
- Urinary Bladder Neoplasms
- Urethral Neoplasms
- Carcinoma, Transitional Cell
- Kidney Neoplasms
- Ureteral Neoplasms
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