Combination Chemotherapy in Treating Patients With Transitional Cell Cancer of the Urothelium

Launched by EUROPEAN ORGANISATION FOR RESEARCH AND TREATMENT OF CANCER - EORTC · Jan 26, 2003

Keywords

ClinConnect Summary

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, multi...

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Eligibility 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