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Pemetrexed Disodium in Treating Patients With Locally Advanced or Metastatic Recurrent Cancer of the Urothelium Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Pemetrexed Disodium in Treating Patients With Locally Advanced or Metastatic Recurrent Cancer of the Urothelium conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Pemetrexed Disodium in Treating Patients With Locally Advanced or Metastatic Recurrent Cancer of the Urothelium Clinical research trials and Pemetrexed Disodium in Treating Patients With Locally Advanced or Metastatic Recurrent Cancer of the Urothelium health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Pemetrexed Disodium in Treating Patients With Locally Advanced or Metastatic Recurrent Cancer of the Urothelium. Pemetrexed Disodium in Treating Patients With Locally Advanced or Metastatic Recurrent Cancer of the Urothelium Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Pemetrexed Disodium in Treating Patients With Locally Advanced or Metastatic Recurrent Cancer of the Urothelium clinical trial. Human subjects often get the best healthcare possible for their Pemetrexed Disodium in Treating Patients With Locally Advanced or Metastatic Recurrent Cancer of the Urothelium condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Pemetrexed Disodium in Treating Patients With Locally Advanced or Metastatic Recurrent Cancer of the Urothelium  Pemetrexed Disodium in Treating Patients With Locally Advanced or Metastatic Recurrent Cancer of the Urothelium
Pemetrexed Disodium in Treating Patients With Locally Advanced or Metastatic Recurrent Cancer of the Urothelium
For Condition: recurrent transitional cell cancer of the renal pelvis and ureter,recurrent 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,stage 4 bladder cancer
Status: No longer recruiting
Sponsor(s): Jonsson Comprehensive Cancer Center , 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. PURPOSE: Phase II trial to study the effectiveness of pemetrexed disodium in treating patients who have locally advanced or metastatic recurrent cancer of the urothelium.
Details: OBJECTIVES: - Determine the antitumor activity of pemetrexed disodium, in terms of tumor response rate, in patients with locally advanced or metastatic recurrent transitional cell carcinoma of the urothelium. - Determine the duration of response, time to progressive disease, time to treatment failure, and survival of patients treated with this drug. - Determine the quantitative and qualitative toxic effects of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed at 30 days and then every 4 months for up to 18 months. PROJECTED ACCRUAL: A total of 14-43 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed stage IV transitional cell carcinoma (TCC) of the urothelium - Mixed histologies allowed provided that the majority of disease is TCC - Measurable or evaluable disease - No clinically significant pleural effusions or ascites - No documented prior or concurrent brain metastases PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - WHO 0-1 Life expectancy: - At least 12 weeks Hematopoietic: - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 9 g/dL Hepatic: - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - AST and ALT no greater than 3 times ULN (5 times ULN if liver metastases present) - Alkaline phosphatase no greater than 3 times ULN (5 times ULN if liver metastases present) Renal: - Creatinine clearance at least 45 mL/min Other: - Able to take folic acid or vitamin B12 supplementation - No active infection - No serious concurrent systemic disorder that would preclude study - No second primary malignancy that is clinically detectable - No other malignancy within the past 5 years except carcinoma in situ of the cervix, adequately treated basal cell or squamous cell skin cancer, or stage I or II adenocarcinoma of the prostate (for which patient completed treatment more than 6 months ago) - No significant weight loss (more than 10%) within the past 6 weeks - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for at least 3 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy: - No concurrent immunotherapy - No concurrent stimulators of thrombopoiesis Chemotherapy: - Less than 12 months since prior adjuvant or neoadjuvant chemotherapy - Prior intravesical therapy allowed - No more than 1 prior chemotherapy regimen for advanced or metastatic disease - No concurrent chemotherapy Endocrine therapy: - No concurrent hormonal anticancer therapy Radiotherapy: - At least 3 weeks since prior radiotherapy and recovered - No prior radiotherapy to sole indicator lesion - No prior radiotherapy to whole pelvis or to 25% or more of bone marrow - No concurrent radiotherapy Surgery: - No concurrent surgery for cancer Other: - At least 30 days since prior investigational agents - No prior pemetrexed disodium therapy - No other concurrent experimental medications - No salicylate or other nonsteroidal anti-inflammatory agents 2 days before, during, and for 2 days after study drug (5 days for agents with a long half-life [e.g., piroxicam, cox-2 inhibitors, naproxen, diflunisal, or nabumetone])
Total Enrollment:
Location and Contact Information:
Overall Study Official:
FairoozKabbinavar, Principal Investigator, Jonsson Comprehensive Cancer Center
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Additional Information:
Study ID Numbers: CDR0000069367; UCLA-0112033,NCI-G02-2072,LILLY-H3E-MC-JMEU
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00039260
Other Stage 4 Bladder Cancer Studies:
1. Combination Chemotherapy in Treating Patients With Stage IV Locally Advanced or Metastatic Bladder Cancer
2. Comparison of Immediate and Delayed Adjuvant Chemotherapy in Treating Patients Who Have Undergone a Radical Cystectomy for Stage III or Stage IV Transitional Cell Carcinoma of the Bladder Urothelium
3. ZD 1839 in Treating Patients With Advanced Cancer of the Urinary Tract
4. Pemetrexed Disodium in Treating Patients With Locally Advanced or Metastatic Recurrent Cancer of the Urothelium
5. Cisplatin, Paclitaxel, and Gemcitabine in Treating Patients With Progressive Unresectable Regional or Metastatic Bladder Cancer
Related Studies:
Other stage 4 bladder cancer Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
Pemetrexed Disodium in Treating Patients With Locally Advanced or Metastatic Recurrent Cancer of the Urothelium
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