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Home > "C" Clinical Trials Conditions > Combination Chemotherapy in Treating Patients With Advanced Bladder or Kidney Cancer  Combination Chemotherapy in Treating Patients With Advanced Bladder or Kidney Cancer
Combination Chemotherapy in Treating Patients With Advanced Bladder or Kidney Cancer
For Condition: metastatic transitional cell cancer of the renal pelvis and ureter,transitional cell carcinoma of the bladder,localized transitional cell cancer of the renal pelvis and ureter,stage 4 bladder cancer,regional transitional cell cancer of the renal pelvis and ureter,stage 3 bladder cancer
Status: Recruiting
Sponsor(s): Memorial Sloan-Kettering Cancer Center , National Cancer Institute (NCI)
Synopsis: 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 I trial to study the effectiveness of combination chemotherapy consisting of gemcitabine, doxorubicin, paclitaxel, and carboplatin in treating patients with advanced bladder or kidney cancer and impaired kidney function.
Details: OBJECTIVES: - Determine the safety and toxicity of dose-dense carboplatin plus paclitaxel on a weekly schedule given in sequence after gemcitabine and doxorubicin in patients with renal impairment and metastatic or locally advanced transitional cell carcinoma of the urothelium. - Observe the outcome of this sequential systemic chemotherapy in these patients, or following surgical resection as adjuvant therapy in patients in whom poor renal function precludes the use of cisplatin-based chemotherapy. OUTLINE: This is a dose escalation study of carboplatin. Patients receive gemcitabine IV over 10 minutes for 6 doses on weeks 1, 2, 3, 5, 6, and 7. On week 9, patients receive doxorubicin IV over 15 minutes for 4 doses at 2 week intervals (weeks 9, 11, 13, and 15). Filgrastim (G-CSF) is given subcutaneously on days 3 through 10 of each 2-week course of doxorubicin. On week 17, patients receive the combination of paclitaxel and carboplatin by one hour continuous infusion weekly for 6 courses. Each cohort of 3 patients is entered on sequentially increasing doses of carboplatin. If any patient experiences dose limiting toxicity (DLT), then 6 patients are entered at that dose level. If 3 patients experience DLT at any dose level, the maximum tolerated dose has been surpassed and a total of 6 patients are treated at the previous level. Patients are evaluated at week 16 and at end of study. PROJECTED ACCRUAL: There will be 18-30 patients accrued into this study over 9-15 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed advanced transitional cell urothelial cancer - Clinical Stage IV: T any, N1-3, M0; T any, N any, M1; or cT4, Nx, M0 (bladder tumors) - Pathological Stage III or IV bladder cancer: T any, N1-3, M0; T3b, N0, M0; T4, N0, M0; and T4, Nx, M0 - Pathological Stage III or IV urothelial cancer of the renal pelvis or ureter: T any, N1-3, M0; T3, N0, M0; T4, N0, M0; and surgery has been performed within 10 weeks of initiation of therapy - Impaired renal function (See Renal function tests) PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 60-100% OR - ECOG 0-1 Life expectancy: - Not specified Hematopoietic: - Granulocyte count at least 1,500/mm^3 - Platelet count at least 150,000/mm^3 Hepatic: - Bilirubin less than 1.5 times normal - Alkaline phosphatase less than 2 times normal - SGOT less than 2 times normal Renal: - Creatinine greater than 1.5 mg/dL but no greater than 2.5 mg/dL OR - Creatinine clearance 30-59 mL/min Cardiovascular: - Normal cardiac function by history, physical examination, and chest radiograph OR - If prior cardiac disease, left ventricular ejection fraction must be at least 50% by radionuclide ventriculogram or echocardiogram - No serious cardiac arrhythmias; including first, second, and third degree heart block - No New York Heart Association class III or IV heart disease Other: - No uncontrolled infection - No other active cancer, except nonmelanomatous skin cancer and in situ carcinoma of the cervix curatively treated - Not pregnant - Effective barrier contraception required for all fertile patients during and for 6 months after therapy (encouraged to continue for 2 years or longer) PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior systemic chemotherapy Endocrine therapy: - Not specified Radiotherapy: - No prior radiotherapy to the bladder - At least 4 weeks since any other prior radiotherapy Surgery: - See Disease Characteristics
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DeanBajorin, Study Chair, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Dean Bajorin 646-422-4333
New York Weill Cornell Cancer Center at Cornell University *Recruiting*
New York City, New York, 10021
United States
Recruiting David Nanus 212-746-2920
Additional Information:
Study ID Numbers: CDR0000066319; MSKCC-97114,NCI-G98-1438
Study Start Date:
Record last reviewed: September 1998
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003342
Other Regional Transitional Cell Cancer Of The Renal Pelvis And Ureter Studies:
1. R115777 in Treating Patients With Advanced Bladder Cancer
2. Gemcitabine, Cisplatin, and Amifostine Following Surgery in Treating Patients With Locally Advanced Bladder Cancer
3. Radiation Therapy and Combination Chemotherapy in Treating Patients With Stage II or Stage III Bladder Cancer
4. Combination Chemotherapy in Treating Patients With Advanced Bladder or Kidney Cancer
5. Transurethral Resection and Combination Chemotherapy in Treating Patients With Stage II or Stage III Bladder Cancer
Related Studies:
Other regional transitional cell cancer of the renal pelvis and ureter Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Combination Chemotherapy in Treating Patients With Advanced Bladder or Kidney Cancer
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