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Phase I/II Trial of Sequential Doxorubicin/Gemcitabine (AG) and Ifosfamide, Paclitaxel, and Cisplatin (ITP) Chemotherapy (AG-ITP) in Patients With Metastatic or Locally Advanced Transitional Cell Carcinoma of the Urothelium


Phase 1/Phase 2
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/II Trial of Sequential Doxorubicin/Gemcitabine (AG) and Ifosfamide, Paclitaxel, and Cisplatin (ITP) Chemotherapy (AG-ITP) in Patients With Metastatic or Locally Advanced Transitional Cell Carcinoma of the Urothelium


OBJECTIVES:

- Determine the safety and toxicity of doxorubicin, gemcitabine, and filgrastim (G-CSF)
followed by ifosfamide, paclitaxel, cisplatin, and G-CSF in patients with metastatic or
locally advanced transitional cell carcinoma of the urothelium.

- Determine the efficacy of this regimen in this patient population.

OUTLINE: This is a dose-escalation study of gemcitabine.

Patients receive doxorubicin IV over 30 minutes and gemcitabine IV on day 1 and filgrastim
(G-CSF) subcutaneously (SC) on days 3-11. Treatment repeats every 2 weeks for 5 courses.

After completion of the fifth course, patients receive paclitaxel IV over 3 hours and
cisplatin IV over 1 hour on day 1, ifosfamide IV over 1 hour on days 1-3, and G-CSF SC daily
on days 6-17. Treatment repeats every 3-4 weeks for 4 courses.

Cohorts of 3-6 patients receive escalating doses of gemcitabine until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 3
of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional
patients are treated at the MTD.

PROJECTED ACCRUAL: A maximum of 20 patients will be accrued for phase I and a maximum of 10
patients will be accrued for phase II within 2-3 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed transitional cell carcinoma of the urothelium

- Measurable disease, defined as unresectable or metastatic urothelial tract tumors OR

- Evaluable disease, defined as T3b or T4a bladder tumors

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Karnofsky 70-100%

Life expectancy:

- Not specified

Hematopoietic:

- Granulocyte count greater than 1,500/mm^3

- Platelet count greater than 150,000/mm^3

Hepatic:

- Bilirubin less than 1.5 times normal

- SGOT less than 2 times normal

Renal:

- Creatinine less than 1.5 mg/dL OR

- Creatinine clearance greater than 60 mL/min

Cardiovascular:

- No New York Heart Association class III or IV heart disease

- No serious cardiac arrhythmias, including first, second, or third degree heart block

- LVEF at least 50%

Other:

- No uncontrolled infection

- No other active malignancy except curatively treated nonmelanomatous skin cancer or
carcinoma in situ of the cervix

- Fertile patients must use effective barrier contraception before, during, and for 6
months after study and are encouraged to continue for 2 years or longer after study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior systemic chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- At least 3 weeks since 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:

CDR0000065841

NCT ID:

NCT00003105

Start Date:

September 1997

Completion Date:

Related Keywords:

  • Bladder Cancer
  • Transitional Cell Cancer of the Renal Pelvis and Ureter
  • stage III bladder cancer
  • recurrent bladder cancer
  • stage IV bladder cancer
  • transitional cell carcinoma of the bladder
  • metastatic transitional cell cancer of the renal pelvis and ureter
  • regional transitional cell cancer of the renal pelvis and ureter
  • recurrent 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 CenterNew York, New York  10021