Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Combination Chemotherapy in Treating Patients With Advanced Bladder or Kidney Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Closed	18 and over	NCI	MSKCC-97114 NCI-G98-1438, NCT00003342

Objectives

1. 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.
2. 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.

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)

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

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/mm³
• Platelet count at least 150,000/mm³

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)

Expected Enrollment

There will be 18-30 patients accrued into this study over 9-15 months.

Outline

This is a dose escalation study of carboplatin.

Patients receive gemcitabine IV over 10 minutes and doxorubicin IV over 15 minutes for 5 doses on weeks 1, 3, 5, 7, and 9. Filgrastim (G-CSF) is given subcutaneously on days 3 through 10 of each 2-week course. On week 11, patients receive paclitaxel and carboplatin IV over 1 hour weekly for 12 weeks.

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.

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Dean Bajorin, MD, Protocol chair		Ph: 646-422-4333; 800-525-2225

Registry Information
Official Title		Phase I Trial of Dose-Dense Gemcitabine, Doxorubicin, Then Paclitaxel Plus Carboplatin In Patients With Transitional Cell Carcinoma of the Urothelium and Impaired Renal Function
Trial Start Date		1997-12-23
Registered in ClinicalTrials.gov		NCT00003342
Date Submitted to PDQ		1998-05-22
Information Last Verified		2005-09-19
NCI Grant/Contract Number		P30-CA08748

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