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Combination Chemotherapy in Treating Patients With Advanced Cancer of the Urothelium and Decreased Kidney Function Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about Combination Chemotherapy in Treating Patients With Advanced Cancer of the Urothelium and Decreased Kidney Function conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Combination Chemotherapy in Treating Patients With Advanced Cancer of the Urothelium and Decreased Kidney Function Clinical research trials and Combination Chemotherapy in Treating Patients With Advanced Cancer of the Urothelium and Decreased Kidney Function health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like Combination Chemotherapy in Treating Patients With Advanced Cancer of the Urothelium and Decreased Kidney Function. Combination Chemotherapy in Treating Patients With Advanced Cancer of the Urothelium and Decreased Kidney Function Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a Combination Chemotherapy in Treating Patients With Advanced Cancer of the Urothelium and Decreased Kidney Function clinical trial. Human subjects often get the best healthcare available for their Combination Chemotherapy in Treating Patients With Advanced Cancer of the Urothelium and Decreased Kidney Function condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy in Treating Patients With Advanced Cancer of the Urothelium and Decreased Kidney Function  Combination Chemotherapy in Treating Patients With Advanced Cancer of the Urothelium and Decreased Kidney Function
Combination Chemotherapy in Treating Patients With Advanced Cancer of the Urothelium and Decreased Kidney Function
For Condition: Cancer of the Renal Pelvis and Ureter,Gastrointestinal Cancer,Urethral Cancer,Bladder Cancer
Status: No longer recruiting
Sponsor(s): Eastern Cooperative Oncology Group , National Cancer Institute (NCI)
Synopsis: 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.
Details: OBJECTIVES: - Determine the response rate of patients with progressive regional or metastatic transitional cell carcinoma of the urothelium with renal insufficiency when treated with paclitaxel and gemcitabine. - Determine the toxicity of this regimen in this patient population. 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed progressive regional or metastatic transitional cell carcinoma of the urothelium - Mixed histologies containing a component of transitional cell carcinoma allowed - Bidimensionally measurable disease - No clinical evidence of CNS metastases - Clinically unsuspected organ-confined prostate cancer found at time of cystoprostatectomy allowed PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - Not specified Hematopoietic: - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than 1.5 mg/dL - SGOT no greater than 2.5 times upper limit of normal (ULN) and alkaline phosphatase normal OR - Alkaline phosphatase no greater than 4 times ULN and SGOT normal OR - SGOT less than 1.5 times ULN and alkaline phosphatase less than 2.5 times ULN Renal: - Creatinine no greater than 3.0 mg/dL - Glomerular filtration rate no greater than 50 mL/min Cardiovascular: - No history of American Heart Association class III or IV heart disease - No uncontrolled congestive heart failure - No severe cardiac arrhythmias Other: - Not pregnant or nursing - Fertile patients must use effective contraception - No preexisting peripheral neuropathy grade 2 or greater - No active unresolved infection requiring parenteral antibiotics within the past 7 days - No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior systemic biologic response modifier therapy for advanced disease - Prior intravesical BCG for superficial disease allowed Chemotherapy: - Prior intravesical chemotherapy for superficial disease allowed - No prior chemotherapy for advanced disease - At least 6 months since prior adjuvant/neoadjuvant methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC) or cisplatin, methotrexate, and vinblastine (CMV), or cisplatin as a radiosensitizer Endocrine therapy: - Not specified Radiotherapy: - At least 4 weeks since prior radiotherapy - No concurrent radiotherapy Surgery: - See Disease Characteristics - At least 4 weeks since prior major surgery and recovered Other: - No concurrent hemodialysis
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DavidVaughn, Study Chair, University of Pennsylvania Cancer Center
CCOP - Marshfield Medical Research and Education Foundation
Marshfield, Wisconsin, 54449
United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, 54301
United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, 52403-1206
United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
United States
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, 07019
United States
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee, Wisconsin, 53295
United States
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
United States
CCOP - Scott and White Hospital
Temple, Texas, 76508
United States
James P. Wilmot Cancer Center
Rochester, New York, 14642
United States
Albert Einstein Clinical Cancer Center
Bronx, New York, 10461
United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104
United States
CCOP - Merit Care Hospital
Fargo, North Dakota, 58122
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226-3596
United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, 57104
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
CCOP - Kalamazoo
Kalamazoo, Michigan, 49007-3731
United States
Additional Information:
Study ID Numbers: CDR0000067810; E-5899
Study Start Date:
Record last reviewed: March 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005644
Other Cancer Of The Renal Pelvis And Ureter Studies:
1. Combination Chemotherapy in Treating Patients With Advanced Cancer of the Urothelium and Decreased Kidney Function
Related Studies:
Other Cancer of the Renal Pelvis and Ureter Clinical Trials
Other Wisconsin Clinical Trials
Other Marshfield Clinical Trials
Combination Chemotherapy in Treating Patients With Advanced Cancer of the Urothelium and Decreased Kidney Function
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