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Fluorouracil, Leucovorin, Gemcitabine, and Cisplatin in Treating Patients With Metastatic or Unresectable Adenocarcinoma of the Urothelium or Urachal Remnant Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Fluorouracil, Leucovorin, Gemcitabine, and Cisplatin in Treating Patients With Metastatic or Unresectable Adenocarcinoma of the Urothelium or Urachal Remnant conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Fluorouracil, Leucovorin, Gemcitabine, and Cisplatin in Treating Patients With Metastatic or Unresectable Adenocarcinoma of the Urothelium or Urachal Remnant Clinical research trials and Fluorouracil, Leucovorin, Gemcitabine, and Cisplatin in Treating Patients With Metastatic or Unresectable Adenocarcinoma of the Urothelium or Urachal Remnant medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Fluorouracil, Leucovorin, Gemcitabine, and Cisplatin in Treating Patients With Metastatic or Unresectable Adenocarcinoma of the Urothelium or Urachal Remnant. Fluorouracil, Leucovorin, Gemcitabine, and Cisplatin in Treating Patients With Metastatic or Unresectable Adenocarcinoma of the Urothelium or Urachal Remnant Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Fluorouracil, Leucovorin, Gemcitabine, and Cisplatin in Treating Patients With Metastatic or Unresectable Adenocarcinoma of the Urothelium or Urachal Remnant clinical trial. Subjects often receive the most expert healthcare possible for their Fluorouracil, Leucovorin, Gemcitabine, and Cisplatin in Treating Patients With Metastatic or Unresectable Adenocarcinoma of the Urothelium or Urachal Remnant condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "F" Clinical Trials Conditions > Fluorouracil, Leucovorin, Gemcitabine, and Cisplatin in Treating Patients With Metastatic or Unresectable Adenocarcinoma of the Urothelium or Urachal Remnant  Fluorouracil, Leucovorin, Gemcitabine, and Cisplatin in Treating Patients With Metastatic or Unresectable Adenocarcinoma of the Urothelium or Urachal Remnant
Fluorouracil, Leucovorin, Gemcitabine, and Cisplatin in Treating Patients With Metastatic or Unresectable Adenocarcinoma of the Urothelium or Urachal Remnant
For Condition: Bladder Cancer,Urethral Cancer
Status: Recruiting
Sponsor(s): M.D. Anderson Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, gemcitabine, and cisplatin, work in 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 II trial to study the effectiveness of combining fluorouracil with leucovorin, gemcitabine, and cisplatin in treating patients who have metastatic or unresectableadenocarcinoma (cancer) of the urothelium or urachal remnant (part of the bladder).
Details: OBJECTIVES: Primary - Determine the response rate and overall survival of patients with metastatic or unresectable adenocarcinoma of the urothelium or urachal remnant treated with fluorouracil, leucovorin calcium, gemcitabine, and cisplatin. Secondary - Determine the toxicity of this regimen in these patients. OUTLINE: Patients are stratified according to diagnosis (adenocarcinoma of the urothelium vs adenocarcinoma of the urachal remnant). Patients receive fluorouracil IV continuously, leucovorin calcium IV once daily, and cisplatin IV once daily on days 1-5 and gemcitabine IV on days 1 and 5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3-6 months. PROJECTED ACCRUAL: A total of 23-46 patients (7-18 with adenocarcinoma of the urachal remnant and 16-28 with adenocarcinoma of the urothelium) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma* of the urothelium or urachal remnant - Metastatic or unresectable disease NOTE: *At least 50% of the histology must be adenocarcinoma - Measurable or evaluable disease* - Bidimensionally measurable disease - Liver and lung lesions at least 1 cm in greatest dimension - Node-only disease at least 1.5 cm in greatest dimension - Disease confined to the bone allowed provided a measurable lytic defect or soft-tissue component is present - Three-dimensional mass or pelvic sidewall fixation on bladder examination under anesthesia is considered measurable disease NOTE: *Patients with no measurable disease allowed provided a serum marker (e.g., carcinoembryonic antigen, CA 125, CA19-9, or βhCG) is at least 4 times upper limit of normal (ULN) - No bladder metastases due to a primary adenocarcinoma arising outside the urinary tract - No uncontrolled CNS metastases PATIENT CHARACTERISTICS: Age - Not specified Performance status - Zubrod 0-2* NOTE: *Zubrod 3 allowed if of recent onset and due entirely to the cancer and not to comorbidity Life expectancy - At least 9 months (based on comorbidity) - At least 9 weeks (based on natural history of the cancer) Hematopoietic - Absolute neutrophil count 1,800/mm^3* - Platelet count 150,000/mm^3* NOTE: *Supranormal values due to benign or inconsequential etiology allowed Hepatic - SGPT or SGOT 2 times ULN - Bilirubin 2 times ULN Renal - Creatinine clearance 35 mL/min Cardiovascular - Ejection fraction 50% for patients with a history of cardiac disease or ischemic heart disease on EKG Other - Not pregnant or nursing - No overt psychosis or mental disability that would preclude giving informed consent - No other life-threatening illness that would preclude study completion - No other malignancy that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - At least 6 weeks since prior pelvic irradiation - No prior radiotherapy to more than 10% of the bone marrow Surgery - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ArleneSiefker-Radtke, Principal Investigator, M.D. Anderson Cancer Center
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030-4009
United States
Recruiting Arlene Siefker-Radtke 713-792-2830
Additional Information:
Study ID Numbers: CDR0000355828; MDA-ID-030111
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00082706
Other Bladder Cancer Studies:
1. Combination Chemotherapy in Treating Patients With Transitional Cell Cancer of the Urothelium
2. Fluorouracil, Leucovorin, Gemcitabine, and Cisplatin in Treating Patients With Metastatic or Unresectable Adenocarcinoma of the Urothelium or Urachal Remnant
3. LMB-9 Immunotoxin in Treating Patients With Advanced Colon, Breast, Non-small Cell Lung, Bladder, Pancreatic, or Ovarian Cancer
4. Trastuzumab and Combination Chemotherapy in Treating Patients With Locally Recurrent or Metastatic Urinary Tract Cancer
5. Combination Chemotherapy Followed By Observation or Surgery in Treating Patients With Stage II or Stage III Cancer of the Urothelium
Related Studies:
Other Bladder Cancer Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Fluorouracil, Leucovorin, Gemcitabine, and Cisplatin in Treating Patients With Metastatic or Unresectable Adenocarcinoma of the Urothelium or Urachal Remnant
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