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Combination Chemotherapy in Treating Patients With Metastatic or Locally Advanced Bladder Cancer
This study is ongoing, but not recruiting participants.
First Received: November 1, 1999   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003105
  Purpose

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/II trial to study the effectiveness of combination chemotherapy in treating patients with metastatic or locally advanced bladder cancer.


Condition Intervention Phase
Bladder Cancer
Transitional Cell Cancer of the Renal Pelvis and Ureter
Biological: filgrastim
Drug: cisplatin
Drug: doxorubicin hydrochloride
Drug: gemcitabine hydrochloride
Drug: ifosfamide
Drug: paclitaxel
Phase I
Phase II

Study Type: Interventional
Study Design: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 30
Study Start Date: September 1997
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003105

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Study Chair: Dean F. Bajorin, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000065841, MSKCC-97095, NCI-G97-1339
Study First Received: November 1, 1999
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00003105     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Antimetabolites
Anti-Infective Agents
Urinary Tract Neoplasm
Immunologic Factors
Ureteral Diseases
Urogenital Neoplasms
Urologic Neoplasms
Carcinoma, Transitional Cell
Anti-Bacterial Agents
Renal Cancer
Urologic Diseases
Cisplatin
Kidney Neoplasms
Kidney Diseases
Bladder Neoplasm
Gemcitabine
Alkylating Agents
Kidney Cancer
Cystocele
Urinary Bladder Diseases
Urinary Bladder Neoplasms
Antimitotic Agents
Immunosuppressive Agents
Antiviral Agents
Recurrence
Doxorubicin
Carcinoma
Ifosfamide
Radiation-Sensitizing Agents
Paclitaxel

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Ureteral Diseases
Urogenital Neoplasms
Antibiotics, Antineoplastic
Urologic Neoplasms
Carcinoma, Transitional Cell
Neoplasms by Site
Urologic Diseases
Cisplatin
Kidney Neoplasms
Therapeutic Uses
Kidney Diseases
Gemcitabine
Alkylating Agents
Neoplasms by Histologic Type
Mitosis Modulators
Urinary Bladder Diseases
Urinary Bladder Neoplasms
Enzyme Inhibitors
Antimitotic Agents
Immunosuppressive Agents
Antiviral Agents
Doxorubicin
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 01, 2009