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Combination Chemotherapy in Treating Patients With Advanced Bladder or Kidney Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003342
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 3, 2013
National Cancer Institute (NCI)
Information provided by:
Memorial Sloan Kettering Cancer Center

November 1, 1999
January 27, 2003
July 3, 2013
December 1997
July 2007   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00003342 on Archive Site
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Combination Chemotherapy in Treating Patients With Advanced Bladder or Kidney Cancer
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

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: This phase I trial is studying the side effects of giving gemcitabine, doxorubicin, and paclitaxel together with carboplatin in treating patients with advanced bladder or kidney cancer and impaired kidney function.


  • 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 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.

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

Phase 1
Primary Purpose: Treatment
  • Bladder Cancer
  • Transitional Cell Cancer of the Renal Pelvis and Ureter
  • Biological: filgrastim
  • Drug: carboplatin
  • Drug: doxorubicin hydrochloride
  • Drug: gemcitabine hydrochloride
  • Drug: paclitaxel
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
July 2007
July 2007   (Final data collection date for primary outcome measure)


  • 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)



  • 18 and over

Performance status:

  • Karnofsky 60-100% OR
  • ECOG 0-1

Life expectancy:

  • Not specified


  • Granulocyte count at least 1,500/mm^3
  • Platelet count at least 150,000/mm^3


  • Bilirubin less than 1.5 times normal
  • Alkaline phosphatase less than 2 times normal
  • SGOT less than 2 times normal


  • Creatinine greater than 1.5 mg/dL but no greater than 2.5 mg/dL OR
  • Creatinine clearance 30-59 mL/min


  • 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


  • 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)


Biologic therapy:

  • Not specified


  • No prior systemic chemotherapy

Endocrine therapy:

  • Not specified


  • No prior radiotherapy to the bladder
  • At least 4 weeks since any other prior radiotherapy


  • See Disease Characteristics
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Dean F. Bajorin, MD Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP