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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Bladder Cancer, Transitional Cell Cancer of the Renal Pelvis and Ureter

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Trial Information

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


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 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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Dean F. Bajorin, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000066319

NCT ID:

NCT00003342

Start Date:

December 1997

Completion Date:

Related Keywords:

  • Bladder Cancer
  • Transitional Cell Cancer of the Renal Pelvis and Ureter
  • stage III bladder cancer
  • stage IV bladder cancer
  • transitional cell carcinoma of the bladder
  • metastatic transitional cell cancer of the renal pelvis and ureter
  • localized transitional cell cancer of the renal pelvis and ureter
  • regional transitional cell cancer of the renal pelvis and ureter
  • Urinary Bladder Neoplasms
  • Carcinoma, Transitional Cell
  • Kidney Neoplasms
  • Ureteral Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer Center New York, New York  10021
New York Weill Cornell Cancer Center at Cornell University New York, New York  10021