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Gemcitabine Plus Pemetrexed Disodium in Treating Patients With Unresectable or Metastatic Biliary Tract or Gallbladder Cancer 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 Gemcitabine Plus Pemetrexed Disodium in Treating Patients With Unresectable or Metastatic Biliary Tract or Gallbladder Cancer conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Gemcitabine Plus Pemetrexed Disodium in Treating Patients With Unresectable or Metastatic Biliary Tract or Gallbladder Cancer Clinical research trials and Gemcitabine Plus Pemetrexed Disodium in Treating Patients With Unresectable or Metastatic Biliary Tract or Gallbladder Cancer 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 Gemcitabine Plus Pemetrexed Disodium in Treating Patients With Unresectable or Metastatic Biliary Tract or Gallbladder Cancer. Gemcitabine Plus Pemetrexed Disodium in Treating Patients With Unresectable or Metastatic Biliary Tract or Gallbladder Cancer 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 Gemcitabine Plus Pemetrexed Disodium in Treating Patients With Unresectable or Metastatic Biliary Tract or Gallbladder Cancer clinical trial. Subjects often receive the most expert healthcare possible for their Gemcitabine Plus Pemetrexed Disodium in Treating Patients With Unresectable or Metastatic Biliary Tract or Gallbladder Cancer 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 > "G" Clinical Trials Conditions > Gemcitabine Plus Pemetrexed Disodium in Treating Patients With Unresectable or Metastatic Biliary Tract or Gallbladder Cancer  Gemcitabine Plus Pemetrexed Disodium in Treating Patients With Unresectable or Metastatic Biliary Tract or Gallbladder Cancer
Gemcitabine Plus Pemetrexed Disodium in Treating Patients With Unresectable or Metastatic Biliary Tract or Gallbladder Cancer
For Condition: unresectable gallbladder cancer,adult primary cholangiocellular carcinoma,unresectable extrahepatic bile duct cancer,advanced adult primary liver cancer
Status: Recruiting
Sponsor(s): North Central Cancer Treatment Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy such as gemcitabine use different ways to stop tumor cells from dividing so they stop growing or die. Pemetrexed disodium may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Combining gemcitabine with pemetrexed disodium may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of combining gemcitabine with pemetrexed disodium in treating patients who have unresectable or metastaticbiliary tract or gallbladder cancer.
Details: OBJECTIVES: - Determine the maximum tolerated dose of gemcitabine when administered with pemetrexed disodium in patients with unresectable or metastatic biliary tract or gallbladder cancer. - Determine the 6-month survival rate of patients treated with this regimen. - Determine the best objective tumor response rate and duration of best objective tumor response in patients treated with this regimen. - Determine the time to progression and overall survival of patients treated with this regimen. - Determine the toxic effects of this regimen in these patients. - Determine the individual patient variation in toxicity of and/or response to this regimen due to genetic differences in proteins involved in drug response in these patients. OUTLINE: This is a phase I dose-escalation study of gemcitabine followed by a phase II multicenter study. - Patients receive pemetrexed disodium IV over 10 minutes and gemcitabine IV over 30 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. 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 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. - Phase II: Patients receive pemetrexed disodium as in phase I and gemcitabine at the recommended phase II dose. Patients are followed every 3 months for 1 year and then every 6 months for 4 years. PROJECTED ACCRUAL: A total of 86 patients (21 for phase I [accruing patients participating at the Mayo Clinic-Rochester center only] and 65 for phase II) will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - One of the following histologically or cytologically confirmed cancers not amenable to treatment with combined chemotherapy and radiotherapy: - Biliary tract (intrahepatic, extrahepatic, or ampulla of Vater) carcinoma - Gallbladder carcinoma - Unresectable or metastatic disease - No CNS metastases - Prior brain metastases treated with surgery or radiosurgery allowed provided treatment was completed at least 4 weeks ago and there is no evidence of CNS progression - No clinically significant pericardial or pleural effusion or ascites unless able to be drained before study entry PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - At least 3 months Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin no greater than 3 times upper limit of normal (ULN) - AST no greater than 5 times ULN Renal - Creatinine no greater than 1.5 times ULN OR - Creatinine clearance at least 45 mL/min Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer - Able to tolerate folic acid, corticosteroids, or cyanocobalamin supplements PRIOR CONCURRENT THERAPY: Biologic therapy - More than 4 weeks since prior biologic or immunologic therapy - No prior biologic or immunologic therapy for metastatic disease - No concurrent immunotherapy - No concurrent colony-stimulating factors during course 1 Chemotherapy - No prior chemotherapy for metastatic disease - No prior gemcitabine - Prior chemoembolization allowed provided the following are true: - At least 4 weeks since prior chemoembolization - Evidence of new tumor growth since therapy - At least 6 months since prior chemotherapy used as a radiosensitizer (in adjuvant setting or for locally advanced disease) - No other concurrent chemotherapy Endocrine therapy - Not specified Radiotherapy - Prior radiofrequency ablation allowed provided the following are true: - At least 4 weeks since prior radiofrequency ablation - Evidence of new tumor growth since therapy - No prior radiotherapy to 25% or more of the bone marrow - More than 4 weeks since prior radiotherapy - No concurrent radiotherapy Surgery - Not specified Other - Prior embolization allowed provided the following are true: - At least 4 weeks since prior embolization - Evidence of new tumor growth since therapy - No prior pemetrexed disodium - No aspirin or nonsteroidal anti-inflammatory drugs for at least 2 days (5 days for long-acting agents [e.g., piroxicam]) before, during, and for at least 2 days after administration of pemetrexed disodium - No concurrent cyclo-oxygenase-2 inhibitors
Total Enrollment:
Location and Contact Information:
Overall Study Official:
StevenAlberts, Study Chair, Mayo Clinic Cancer Center
Mayo Clinic *Recruiting*
Jacksonville, Florida, 32224
United States
Recruiting Edith Perez 904-953-0118
Mayo Clinic Cancer Center *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting Steven Alberts 507-284-2511
Additional Information:
Study ID Numbers: CDR0000298862; NCCTG-N9943
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00059865
Other Unresectable Extrahepatic Bile Duct Cancer Studies:
1. 3-AP and Gemcitabine in Treating Patients With Unresectable or Metastatic Biliary Duct or Gallbladder Cancer
2. Combination Chemotherapy in Treating Patients With Unresectable or Metastatic Biliary Tract or Gallbladder Cancer
3. Radiation Therapy in Treating Patients With Bile Duct, Gallbladder, or Pancreatic Cancer
4. DX-8951f in Treating Patients With Biliary Cancer
5. Gemcitabine Plus Pemetrexed Disodium in Treating Patients With Unresectable or Metastatic Biliary Tract or Gallbladder Cancer
Related Studies:
Other unresectable extrahepatic bile duct cancer Clinical Trials
Other Florida Clinical Trials
Other Jacksonville Clinical Trials
Gemcitabine Plus Pemetrexed Disodium in Treating Patients With Unresectable or Metastatic Biliary Tract or Gallbladder Cancer
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