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Tezacitabine with or without 5-Fluorouracil (5-FU) for advanced esophageal cancer or gastric cancer Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Tezacitabine with or without 5-Fluorouracil (5-FU) for advanced esophageal cancer or gastric cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Tezacitabine with or without 5-Fluorouracil (5-FU) for advanced esophageal cancer or gastric cancer Clinical research trials and Tezacitabine with or without 5-Fluorouracil (5-FU) for advanced esophageal cancer or gastric cancer medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Tezacitabine with or without 5-Fluorouracil (5-FU) for advanced esophageal cancer or gastric cancer. Tezacitabine with or without 5-Fluorouracil (5-FU) for advanced esophageal cancer or gastric cancer Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Tezacitabine with or without 5-Fluorouracil (5-FU) for advanced esophageal cancer or gastric cancer clinical trial. Participants frequently get the best healthcare available for their Tezacitabine with or without 5-Fluorouracil (5-FU) for advanced esophageal cancer or gastric cancer condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "T" Clinical Trials Conditions > Tezacitabine with or without 5-Fluorouracil (5-FU) for advanced esophageal cancer or gastric cancer  Tezacitabine with or without 5-Fluorouracil (5-FU) for advanced esophageal cancer or gastric cancer
Tezacitabine with or without 5-Fluorouracil (5-FU) for advanced esophageal cancer or gastric cancer
For Condition: Stomach Neoplasms,Esophageal Neoplasms,Adenocarcinoma
Status: Recruiting
Sponsor(s): Chiron Corporation ,
Synopsis: The purpose of this study is to evaluate the efficacy and safety of tezacitabine when given alone or in combination with 5-fluorouracil (5-FU) to subjects who have advanced esophageal or gastric adenocarcinoma.
Details:
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Males and females greater than or equal to 18 years of age. - Histologically confirmed recurrent (inoperable) or metastatic adenocarcinoma of the esophagus, gastroesophageal junction, or stomach. - At least one bidimensionally measurable lesion, not previously irradiated, with a diameter that meets RECIST criteria, that can be serially measured. Intraluminal tumors, evaluable only by endoscopy, are not acceptable as target lesions. - Karnofsky Performance Score greater than or equal to 70%. - Subjects must be in the second line therapy setting, thus they must have experienced progression following treatment with one (and only one) prior chemotherapy regimen used for the treatment of unresectable locally advanced, recurrent, or metastatic disease. - Recovery from any serious (grade 3 or higher) toxic effects of prior radiation therapy. - Adequate hematologic profile: absolute neutrophil count greater than or equal to 1,500/mm3; hemoglobin greater than or equal to 9 g/dL; hematocrit greater than or equal to 30% (transfusion allowed); and platelet count greater than or equal to 100,000/mm3. - Adequate hepatic function: bilirubin less than or equal to 1.5 mg/dL; AST and ALT less that 2.5 X ULN (5 X ULN if liver involved with tumor); alkaline phosphatase less than 5 X ULN - Adequate renal function; serum creatinine less than or equal to 1.5 mg/dL or calculated creatinine clearance greater than 50 mL/min. - Both male and female subjects of childbearing potential must be using a contraceptive method that is medically acceptable to the investigative center. - Disease-free from a prior malignancy, other than non-melanoma skin cancer or carcinoma in-situ of the cervix, for greater than 5 years. Exclusion Criteria: - Unstable angina or class III or IV New York Heart Association heart disease. - CNS metastases. - Pregnant or breast-feeding. - Uncontrolled seizure disorder. - Ongoing (grade 3 or higher) stomatitis, esophagopharyngitis, or uncontrolled diarrhea. - Impaired nutritional status as evidenced by a serum albumin of 2.7 mg/dL or less. - Major surgery, chemotherapy, immunotherapy, or radiotherapy during the 28 days preceding the first study treatment. Concomitant anticancer therapy (chemotherapy, immunotherapy, or radiation) or other investigational agents during study participation or 28 days prior to study participation.
Total Enrollment:
Location and Contact Information:
Sharp Clinical Oncology Research *Recruiting*
San Diego, California, 92123
United States
Recruiting
Northwestern University, Feinberg School of Medicine, Division of Hematology/Oncology *Recruiting*
Chicago, Illinois, 60611
United States
Recruiting
Cleveland Clinic Foundation *Recruiting*
Cleveland, Ohio, 44195
United States
Recruiting
Kansas City Oncology and Hematology Group *Recruiting*
Kansas City, Missouri, 64111
United States
Recruiting
Duke University Medical Center *Recruiting*
Durham, North Carolina, 27710
United States
Recruiting
Denver VAMC *Recruiting*
Denver, Colorado, 80220
United States
Recruiting
University of Texas, MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030
United States
Recruiting
USC/Norris Comprehensive Cancer Center *Recruiting*
Los Angeles, California, 90033
United States
Recruiting
Washington University School of Medicine *Recruiting*
St. Louis, Missouri, 63110
United States
Recruiting
Ochsner Clinic Foundation *Recruiting*
New Orleans, Louisiana, 70121
United States
Recruiting
ACRC/Arizona Clinical Research Center *Recruiting*
Tucson, Arizona, 85712
United States
Recruiting
The University of Chicago *Recruiting*
Chicago, Illinois, 60637
United States
Recruiting
UCSF Comprehensive Cancer Center *Recruiting*
San Francisco, California, 94115-1705
United States
Recruiting
Desert Regional Medical Center *Recruiting*
Palm Springs, California, 92262
United States
Recruiting
Fox Chase Cancer Center *Recruiting*
Philadelphia, Pennsylvania, 19111
United States
Recruiting
Memorial Regional Comprehensive Cancer Center *Recruiting*
Weston, Florida, 33326
United States
Recruiting
Swedish Cancer Institute *Recruiting*
Seattle, Washington, 98104
United States
Recruiting
Josephine Ford Cancer Center, Henry Ford Health System *Recruiting*
Detroit, Michigan, 48202
United States
Recruiting
Comprehensive Cancer Center at DRMC *Recruiting*
Palm Springs, California, 92262
United States
Recruiting
The Sarah Cannon Cancer Center, Tennessee Oncology *Recruiting*
Nashville, Tennessee, 37203
United States
Recruiting
LSU Health Sciences Center, Dept. of Medicine, Hematology/Oncology *Recruiting*
Shreveport, Louisiana, 77130
United States
Recruiting
Vanderbilt-Ingram Cancer Center *Recruiting*
Nashville, Tennessee, 37232
United States
Recruiting
University of Michigan Medical Center
Ann Arbor, Michigan, 48109-0922
United States
Glendale Memorial Hospital *Recruiting*
Glendale, California, 91204
United States
Recruiting
Tower Hematology Oncology Medical Group *Recruiting*
Los Angeles, California, 90048
United States
Recruiting
Massachusetts General Hospital *Recruiting*
Boston, Massachusetts, 02114
United States
Recruiting
H. Lee Moffitt Cancer Center and Research Institute *Recruiting*
Tampa, Florida, 33612-9497
United States
Recruiting
Cancer Institute Medical Group *Recruiting*
Santa Monica, California, 90404
United States
Recruiting
University of Alabama at Birmingham *Recruiting*
Birmingham, Alabama, 35294
United States
Recruiting
Additional Information:
Study ID Numbers: TEZ001;
Study Start Date:
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00054873
Other Adenocarcinoma Studies:
1. Tezacitabine with or without 5-Fluorouracil (5-FU) for advanced esophageal cancer or gastric cancer
2. Study of T900607-sodium in subjects with previously treated gastric cancer or adenocarcinoma of the esophagus
3. A Safety and Effectiveness Study of Aroplatin in Patients with Advanced Solid Malignancies
4. Magnetic-Targeted Doxorubicin in Treating Patients with Cancer Metastatic to the Liver
Related Studies:
Other Adenocarcinoma Clinical Trials
Other Missouri Clinical Trials
Other Kansas City Clinical Trials
Tezacitabine with or without 5-Fluorouracil (5-FU) for advanced esophageal cancer or gastric cancer
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