Combination Chemotherapy in Treating Patients With Advanced Cancer of the Urothelium and Decreased Kidney Function

Eastern Cooperative Oncology Group

Overview

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 cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have advanced cancer of the urothelium with decreased kidney function.

OBJECTIVES: * Determine the response rate of patients with progressive regional or metastatic transitional cell carcinoma of the urothelium with renal insufficiency when treated with paclitaxel and gemcitabine. * Determine the toxicity of this regimen in this patient population. OUTLINE: Patients receive paclitaxel IV over 1 hour followed immediately by gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment continues every 4 weeks for a minimum of 3 courses in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 10-27 patients will be accrued for this study within 10-27 months.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

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

Interventions

gemcitabine hydrochlorideDRUG

paclitaxelDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: * Histologically confirmed progressive regional or metastatic transitional cell carcinoma of the urothelium * Mixed histologies containing a component of transitional cell carcinoma allowed * Bidimensionally measurable disease * No clinical evidence of CNS metastases * Clinically unsuspected organ-confined prostate cancer found at time of cystoprostatectomy allowed PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 mg/dL * SGOT no greater than 2.5 times upper limit of normal (ULN) and alkaline phosphatase normal OR * Alkaline phosphatase no greater than 4 times ULN and SGOT normal OR * SGOT less than 1.5 times ULN and alkaline phosphatase less than 2.5 times ULN Renal: * Creatinine no greater than 3.0 mg/dL * Glomerular filtration rate no greater than 50 mL/min Cardiovascular: * No history of American Heart Association class III or IV heart disease * No uncontrolled congestive heart failure * No severe cardiac arrhythmias Other: * Not pregnant or nursing * Fertile patients must use effective contraception * No preexisting peripheral neuropathy grade 2 or greater * No active unresolved infection requiring parenteral antibiotics within the past 7 days * No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior systemic biologic response modifier therapy for advanced disease * Prior intravesical BCG for superficial disease allowed Chemotherapy: * Prior intravesical chemotherapy for superficial disease allowed * No prior chemotherapy for advanced disease * At least 6 months since prior adjuvant/neoadjuvant methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC) or cisplatin, methotrexate, and vinblastine (CMV), or cisplatin as a radiosensitizer Endocrine therapy: * Not specified Radiotherapy: * At least 4 weeks since prior radiotherapy * No concurrent radiotherapy Surgery: * See Disease Characteristics * At least 4 weeks since prior major surgery and recovered Other: * No concurrent hemodialysis

Locations (16)

CCOP - Cedar Rapids Oncology Project

Cedar Rapids, Iowa, United States

CCOP - Kalamazoo

Kalamazoo, Michigan, United States

Data from ClinicalTrials.gov

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