Combination Chemotherapy in Treating Patients With Metastatic or Locally Advanced Bladder Cancer
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ClinicalTrials.gov Identifier: NCT00003105 |
Recruitment Status :
Completed
First Posted : January 27, 2003
Last Update Posted : July 3, 2013
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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 or disease | Intervention/treatment | 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 1 Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Primary Purpose: | 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 |
Study Start Date : | September 1997 |
Actual Primary Completion Date : | August 2004 |
Actual Study Completion Date : | August 2004 |


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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003105
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 |
Study Chair: | Dean F. Bajorin, MD | Memorial Sloan Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT00003105 |
Other Study ID Numbers: |
97-095 CDR0000065841 ( Registry Identifier: PDQ (Physician Data Query) ) NCI-G97-1339 |
First Posted: | January 27, 2003 Key Record Dates |
Last Update Posted: | July 3, 2013 |
Last Verified: | July 2013 |
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 Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplasms Urinary Bladder Diseases Urologic Diseases Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Kidney Diseases Ureteral Diseases |
Gemcitabine Paclitaxel Cisplatin Doxorubicin Liposomal doxorubicin Ifosfamide Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antimetabolites Antiviral Agents |