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| ID | Type | Description | Link |
|---|---|---|---|
| E-5899 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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 cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have advanced cancer of the urothelium with decreased kidney function.
OBJECTIVES:
OUTLINE: Patients receive paclitaxel IV over 1 hour followed immediately by gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment continues every 4 weeks for a minimum of 3 courses in the absence of unacceptable toxicity or disease progression.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 10-27 patients will be accrued for this study within 10-27 months.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gemcitabine hydrochloride | Drug | |||
| paclitaxel | Drug |
DISEASE CHARACTERISTICS:
Histologically confirmed progressive regional or metastatic transitional cell carcinoma of the urothelium
Bidimensionally measurable disease
No clinical evidence of CNS metastases
Clinically unsuspected organ-confined prostate cancer found at time of cystoprostatectomy allowed
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Name | Affiliation | Role |
|---|---|---|
| David J. Vaughn, MD | Abramson Cancer Center at Penn Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CCOP - Cedar Rapids Oncology Project | Cedar Rapids | Iowa | 52403-1206 | United States | ||
| CCOP - Kalamazoo |
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| Kalamazoo |
| Michigan |
| 49007-3731 |
| United States |
| Veterans Affairs Medical Center - East Orange | East Orange | New Jersey | 07019 | United States |
| James P. Wilmot Cancer Center | Rochester | New York | 14642 | United States |
| Albert Einstein Clinical Cancer Center | The Bronx | New York | 10461 | United States |
| CCOP - Merit Care Hospital | Fargo | North Dakota | 58122 | United States |
| Ireland Cancer Center | Cleveland | Ohio | 44106-5065 | United States |
| Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio | 44195 | United States |
| University of Pennsylvania Cancer Center | Philadelphia | Pennsylvania | 19104 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| CCOP - Sioux Community Cancer Consortium | Sioux Falls | South Dakota | 57104 | United States |
| CCOP - Scott and White Hospital | Temple | Texas | 76508 | United States |
| CCOP - St. Vincent Hospital Cancer Center, Green Bay | Green Bay | Wisconsin | 54301 | United States |
| CCOP - Marshfield Medical Research and Education Foundation | Marshfield | Wisconsin | 54449 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226-3596 | United States |
| Veterans Affairs Medical Center - Milwaukee (Zablocki) | Milwaukee | Wisconsin | 53295 | United States |
| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| D014523 | Urethral Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D014522 | Urethral Diseases |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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