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Triacetyluridine and Fluorouracil Compared With Gemcitabine in Treating Patients With Unresectable Locally Advanced, or Metastatic Pancreatic Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Triacetyluridine and Fluorouracil Compared With Gemcitabine in Treating Patients With Unresectable Locally Advanced, or Metastatic Pancreatic Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Triacetyluridine and Fluorouracil Compared With Gemcitabine in Treating Patients With Unresectable Locally Advanced, or Metastatic Pancreatic Cancer Clinical research trials and Triacetyluridine and Fluorouracil Compared With Gemcitabine in Treating Patients With Unresectable Locally Advanced, or Metastatic Pancreatic Cancer medical trials happen in hundreds of localities throughout the U.S.A.. 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 does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Triacetyluridine and Fluorouracil Compared With Gemcitabine in Treating Patients With Unresectable Locally Advanced, or Metastatic Pancreatic Cancer. Triacetyluridine and Fluorouracil Compared With Gemcitabine in Treating Patients With Unresectable Locally Advanced, or Metastatic Pancreatic Cancer Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Triacetyluridine and Fluorouracil Compared With Gemcitabine in Treating Patients With Unresectable Locally Advanced, or Metastatic Pancreatic Cancer clinical trial. Participants frequently obtain the most expert healthcare available for their Triacetyluridine and Fluorouracil Compared With Gemcitabine in Treating Patients With Unresectable Locally Advanced, or Metastatic Pancreatic Cancer condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "T" Clinical Trials Conditions > Triacetyluridine and Fluorouracil Compared With Gemcitabine in Treating Patients With Unresectable Locally Advanced, or Metastatic Pancreatic Cancer  Triacetyluridine and Fluorouracil Compared With Gemcitabine in Treating Patients With Unresectable Locally Advanced, or Metastatic Pancreatic Cancer
Triacetyluridine and Fluorouracil Compared With Gemcitabine in Treating Patients With Unresectable Locally Advanced, or Metastatic Pancreatic Cancer
For Condition: Pancreatic Cancer,Drug Toxicity,adenocarcinoma of the pancreas
Status: Recruiting
Sponsor(s): Wellstat Therapeutics ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving the drugs in different combinations may kill more tumor cells. Chemoprotective drugs such as triacetyluridine may protect normal cells from the side effects of chemotherapy. It is not yet known which chemotherapy regimen is more effective in treating pancreatic cancer. PURPOSE: Randomizedphase III trial to compare the effectiveness of fluorouracil plus triacetyluridine with that of gemcitabine in treating patients who have locally advanced or metastatic pancreatic cancer that cannot be treated with surgery.
Details: OBJECTIVES: - Compare the survival of patients with unresectable locally advanced or metastatic pancreatic cancer treated with triacetyluridine and high-dose fluorouracil vs gemcitabine. - Compare the time to tumor progression, overall response rate, and response duration in patients treated with these regimens. - Compare the safety of these regimens in these patients. OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to disease stage (II or III vs IV). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive high-dose fluorouracil (5-FU) IV over 30 minutes once weekly on weeks 1-3 followed by 1 week of rest. After each dose of 5-FU, patients receive oral triacetyluridine every 8 hours for a total of 8 doses. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. - Arm II: Patients receive gemcitabine IV over 30 minutes once weekly on weeks 1-7 followed by 1 week of rest (course 1). Subsequent courses are given on weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed for survival. PROJECTED ACCRUAL: A total of 260 patients (130 per treatment arm) will be accrued for this study within 30 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed adenocarcinoma of the pancreas - Unresectable locally advanced or metastatic disease - Stage II, III, or IV - Measurable or evaluable disease - No elevated tumor marker (CA 19-9) only - No clinically significant third-space fluid accumulation (e.g., ascites or pleural effusion) - No carcinoid, islet cell, or lymphoma of the pancreas - No prior or concurrent brain or leptomeningeal metastases PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 70-100% Life expectancy: - At least 3 months Hematopoietic: - WBC at least 3,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 9.5 g/dL Hepatic: - Bilirubin no greater than 2.0 mg/dL - ALT or AST less than 3 times upper limit of normal (ULN) (5 times ULN if liver metastases present) - No uncontrolled hepatic dysfunction Renal: - Creatinine less than 2.0 mg/dL - No uncontrolled renal dysfunction Cardiovascular: - No uncontrolled cardiovascular disease requiring therapy, including the following: - Angina - Arrhythmias - Uncompensated cardiac failure - Myocardial infarction within the past 6 months Pulmonary: - No uncontrolled pulmonary dysfunction Gastrointestinal: - Able to take and/or retain oral medication - No uncontrolled malabsorption syndrome or any other condition that would interfere with intestinal absorption Other: - No known allergy to fluorouracil (5-FU), gemcitabine, triacetyluridine, or any of their components - No dihydropyrimidine-dehydrogenase deficiency - No active uncontrolled infection - No uncontrolled neurologic or psychiatric dysfunction - No other malignancy except previously resected basal cell cancer or curatively resected stage I or less cervical cancer that has been disease free for at least 5 years - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: - No concurrent biologic therapy (including immunotherapy) for cancer Chemotherapy: - No prior chemotherapy for cancer other than as a radiosensitizer - No prior 5-FU or gemcitabine other than as a radiosensitizer - No prior triacetyluridine - No other concurrent chemotherapy (including leucovorin calcium) for cancer Endocrine therapy: - No concurrent hormonal therapy for cancer - Concurrent megestrol, oral contraceptives, or postmenopausal estrogen replacement therapy allowed Radiotherapy: - Prior radiotherapy allowed - No concurrent radiotherapy Surgery: - See Disease Characteristics - Prior resection of pancreas allowed Other: - At least 30 days since prior investigational drug or therapeutic device - No other concurrent anticancer therapy - No other concurrent investigational drugs or devices - No concurrent drugs that would interact adversely with 5-FU or gemcitabine
Total Enrollment:
Location and Contact Information:
Overall Study Official:
LennySmith, Study Chair, Wellstat Therapeutics
Providence Saint Joseph Medical Center - Burbank *Recruiting*
Burbank, California, 91505
United States
Recruiting Raul Mena 818-847-3218
Medical City Dallas Hospital *Recruiting*
Dallas, Texas, 75230
United States
Recruiting Mark Capistrano 972-566-4175
St. John's Mercy Medical Center *Recruiting*
St. Louis, Missouri, 63141
United States
Recruiting John Eckardt 314-569-6933 ext. 4083
Memorial Regional Hospital Comprehensive Cancer Center *Recruiting*
Hollywood, Florida, 33021
United States
Recruiting Atif Hussein 954-986-6363
Florida Oncology Associates *Recruiting*
Jacksonville, Florida, 32207
United States
Recruiting Yousif Abubakr 904-739-7779
Swedish-American Regional Cancer Center *Recruiting*
Rockford, Illinois, 61104
United States
Recruiting William Schulz 815-489-4413
Temple University Hospital *Recruiting*
Philadelphia, Pennsylvania, 19140-5158
United States
Recruiting Nevena Damjanov 215-707-2777
Veterans Affairs Medical Center - Palo Alto *Recruiting*
Palo Alto, California, 94304
United States
Recruiting Tony Reid 650-493-5000 ext. 62039
Florida Cancer Specialists *Recruiting*
Ft. Myers, Florida, 33908
United States
Recruiting James Reeves 239-274-9930
Cancer Centers of the Carolinas - Eastside *Recruiting*
Greenville, South Carolina, 29615
United States
Recruiting Jeffrey Giguere 864-987-7000
Oncology & Hematology Associates of West Broward *Recruiting*
Tamarac, Florida, 33321
United States
Recruiting Sumit Sawhney 954-726-0035
Columbia Comprehensive Cancer Care Clinic *Recruiting*
Columbia, Missouri, 65201
United States
Recruiting Ali Khojasteh 573-893-6404
Penn State Cancer Institute at Milton S. Hershey Medical Center *Recruiting*
Hershey, Pennsylvania, 17033-0850
United States
Recruiting Jill Smith 717-531-0123
Corpus Christi Cancer Center *Recruiting*
Corpus Christi, Texas, 78412
United States
Recruiting Albert Wood 361-993-3456
Greater Baltimore Medical Center and Cancer Center *Recruiting*
Baltimore, Maryland, 21204-6881
United States
Recruiting Gary Cohen 443-849-3051
Green Cancer Center at Scripps Clinic *Recruiting*
La Jolla, California, 92037
United States
Recruiting William Miller 858-554-8832
Cancer Center at Hackensack University Medical Center *Recruiting*
Hackensack, New Jersey, 07601
United States
Recruiting Robert Alter 201-996-5900
Cancer Care Center *Recruiting*
New Albany, Indiana, 47150
United States
Recruiting Naveed Chowhan 812-945-4000
CCOP - Metro-Minnesota *Recruiting*
St. Louis Park, Minnesota, 55416
United States
Recruiting Patrick Flynn 952-993-15175
Summit Oncology Associates *Recruiting*
Akron, Ohio, 44304
United States
Recruiting Douglas Trochelman 330-375-4221
St. Joseph's Hospital *Recruiting*
Savannah, Georgia, 31419
United States
Recruiting Ray Maddox 912-692-6404
University of New Mexico Cancer Research and Treatment Center *Recruiting*
Albuquerque, New Mexico, 87131
United States
Recruiting Fa-Chyi Lee 505-272-2776
Southwest Oncology Association *Recruiting*
Lafayette, Louisiana, 70503
United States
Recruiting Luis Meza 337-234-4535
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center *Recruiting*
Spartanburg, South Carolina, 29303
United States
Recruiting James Bearden 864-560-6812
Washington Cancer Institute *Recruiting*
Washington D.C., District of Columbia, 20010
United States
Recruiting David Perry 202-877-2843
University of Alabama at Birmingham Comprehensive Cancer Center *Recruiting*
Birmingham, Alabama, 35293-3300
United States
Recruiting Albert LoBuglio 205-975-7162
South West Oncology Associates *Recruiting*
Lafayette, Louisiana, 70503
United States
Recruiting Luis Meza 337-234-4535
McGill University *Recruiting*
Montreal, Quebec, H2W 1S6
Canada
Recruiting Wilson Miller 514-398-1444
Northwestern Ontario Regional Cancer Care *Recruiting*
Thunder Bay, Ontario, P7B 6V4
Canada
Recruiting Dimitrios Vergidis 807-343-1610
Florida Cancer Institute *Recruiting*
New Port Richey, Florida, 34652
United States
Recruiting William Paladine 727-843-9841
Pasco Pinellas Cancer Center - Tarpon Springs *Recruiting*
Tarpon Springs, Florida, 34689
United States
Recruiting Julio Hajdenberg 727-849-6690
New York Weill Cornell Cancer Center at Cornell University *Recruiting*
New York City, New York, 10021
United States
Recruiting Roger Keresztes 212-746-3915
Abramson Cancer Center at University of Pennsylvania Medical Center *Recruiting*
Philadelphia, Pennsylvania, 19104
United States
Recruiting Daniel Haller 215-662-6318
Ottawa Regional Cancer Centre *Recruiting*
Ottawa, Ontario, K1H 1C4
Canada
Recruiting Jean Maroun 613-737-7700, ext. 6802
Capitol Comprehensive Cancer Care Clinic *Recruiting*
Jefferson City, Missouri, 65109
United States
Recruiting Ali Khojasteh 573-893-6404
Northwest Oncology and Hematology Associates *Recruiting*
Coral Springs, Florida, 33065
United States
Recruiting Steven Weiss 954-755-1904
Brookwood Medical Center *Recruiting*
Birmingham, Alabama, 35209-6804
United States
Recruiting Luigi Bertoli 205-824-3635
University of Miami Sylvester Cancer Center *Recruiting*
Miami, Florida, 33136
United States
Recruiting Pasquale Benedetto 305-243-4909
Pearlman Comprehensive Cancer Center at South Georgia Medical Center *Recruiting*
Valdosta, Georgia, 31602
United States
Recruiting Jeffrey Hoy 229-259-4628
St. Luke's Hospital *Recruiting*
Duluth, Minnesota, 55805-1983
United States
Recruiting Ron Kirschling 218-249-3081
Queens Medical Associates, PC *Recruiting*
Fresh Meadows, New York, 11365
United States
Recruiting Barry Kaplan 718-460-2300 ext. 614
Wellstat Therapeutics *Recruiting*
Gaithersburg, Maryland, 20878
United States
Recruiting Patient Hotline 866-812-8504
Jackson Oncology Associates, PLLC *Recruiting*
Jackson, Mississippi, 39202
United States
Recruiting Gerry Houston 601-355-2485
City of Hope Comprehensive Cancer Center *Recruiting*
Duarte, California, 91010-3000
United States
Recruiting Stephen Shibata 626-359-8111 ext. 63087
Additional Information:
Study ID Numbers: CDR0000068931; PRONEURON-401.00.001,UAB-F010524008,WELLSTAT-401.00.001,UAB-0105
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00024427
Other Drug Toxicity Studies:
1. Electroporation Therapy With Bleomycin in Treating Patients With Pancreatic Cancer
2. Fluorouracil, Gemcitabine, and Radiation Therapy in Treating Patients With Cancer of the Pancreas
3. Fluorouracil With or Without Cisplatin in Treating Patients With Advanced or Metastatic Cancer of the Pancreas
4. Gemcitabine Plus Radiation Therapy in Treating Patients With Pancreatic Cancer
5. Flavopiridol Plus Radiation Therapy Followed By Gemcitabine in Treating Patients With Locally Advanced, Unresectable Pancreatic Cancer
Related Studies:
Other Drug Toxicity Clinical Trials
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Other New Port Richey Clinical Trials
Triacetyluridine and Fluorouracil Compared With Gemcitabine in Treating Patients With Unresectable Locally Advanced, or Metastatic Pancreatic Cancer
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