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Oxaliplatin With Fluorouracil and Leucovorin in Treating Patients With Recurrent or Metastatic Cancer of the Esophagus or Stomach Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Oxaliplatin With Fluorouracil and Leucovorin in Treating Patients With Recurrent or Metastatic Cancer of the Esophagus or Stomach conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Oxaliplatin With Fluorouracil and Leucovorin in Treating Patients With Recurrent or Metastatic Cancer of the Esophagus or Stomach Clinical research trials and Oxaliplatin With Fluorouracil and Leucovorin in Treating Patients With Recurrent or Metastatic Cancer of the Esophagus or Stomach health trials occur in hundreds of cities 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 assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Oxaliplatin With Fluorouracil and Leucovorin in Treating Patients With Recurrent or Metastatic Cancer of the Esophagus or Stomach. Oxaliplatin With Fluorouracil and Leucovorin in Treating Patients With Recurrent or Metastatic Cancer of the Esophagus or Stomach Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Oxaliplatin With Fluorouracil and Leucovorin in Treating Patients With Recurrent or Metastatic Cancer of the Esophagus or Stomach clinical trial. Participants oftentimes recieve the most expert healthcare available for their Oxaliplatin With Fluorouracil and Leucovorin in Treating Patients With Recurrent or Metastatic Cancer of the Esophagus or Stomach condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "O" Clinical Trials Conditions > Oxaliplatin With Fluorouracil and Leucovorin in Treating Patients With Recurrent or Metastatic Cancer of the Esophagus or Stomach  Oxaliplatin With Fluorouracil and Leucovorin in Treating Patients With Recurrent or Metastatic Cancer of the Esophagus or Stomach
Oxaliplatin With Fluorouracil and Leucovorin in Treating Patients With Recurrent or Metastatic Cancer of the Esophagus or Stomach
For Condition: stage 4 esophageal cancer,recurrent esophageal cancer,adenocarcinoma of the stomach,Adenocarcinoma of the Esophagus,recurrent gastric cancer,stage 4 gastric cancer
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , University of Chicago Cancer Research Center
Synopsis: RATIONALE: Drugs used in chemotherapy use 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 oxaliplatin, fluorouracil, and leucovorin in treating patients who have recurrent or metastatic cancer of the esophagus or stomach.
Details: OBJECTIVES: I. Determine the response rate in patients with recurrent or metastatic carcinoma of the esophagus or gastric cardia receiving the combination of oxaliplatin, fluorouracil, and leucovorin calcium. II. Determine the duration of response and overall survival of this patient population receiving this regimen. III. Determine the toxicity, including neurotoxicity, of this regimen in this patient population. PROTOCOL OUTLINE: This is an open label, multicenter study. Patients receive oxaliplatin IV over 2 hours on day 1, then leucovorin calcium IV over 2 hours with fluorouracil IV bolus, followed by fluorouracil IV over 22 hours on days 1 and 2. Treatment continues every 2 weeks for a minimum of 3 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease receive at least 3 additional courses of therapy. Patients are followed for a minimum of 2 years or until death. PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study over 18 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically or cytologically confirmed carcinoma of the esophagus or gastric cardia; Stage IV or recurrent - Bidimensionally measurable disease --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: At least 4 weeks since prior chemotherapy; No more than 1 prior chemotherapy regimen for carcinoma of the esophagus or gastric cardia; No prior fluorouracil - Endocrine therapy: Not specified - Radiotherapy: At least 4 weeks since prior radiotherapy - Surgery: Not specified - Other: No other concurrent investigational agents --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-2; Karnofsky 50-100% - Life expectancy: Not specified - Hematopoietic: WBC greater than 3,000/mm3; Absolute neutrophil count at least 1,500/mm3; Platelet count greater than 100,000/mm3; Hemoglobin greater than 10 g/dL - Hepatic: Bilirubin normal; SGOT less than 2 times upper limit of normal (ULN) - Renal: BUN less than 1.5 times ULN; Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 50 mL/min - Cardiovascular: No congestive heart failure; No unstable angina pectoris; No myocardial infarction within the past 6 months - Other: Not pregnant or nursing; Fertile patients must use effective contraception during and for 6 months after study; No allergy to platinum compounds or antiemetics appropriate for study; No uncontrolled concurrent illness; No active infection; No HIV positive patients receiving antiretroviral therapy (HAART); No clinical evidence of peripheral neuropathy by physical exam or history
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AnnMauer, Study Chair, University of Chicago Cancer Research Center
Louis A. Weiss Memorial Hospital
Chicago, Illinois, 60640
United States
University of Puerto Rico School of Medicine Medical Sciences Campus
San Juan, , 00936-5067
Puerto Rico
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
University of Illinois at Chicago
Chicago, Illinois, 60612
United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
United States
Grant/Riverside Methodist Hospitals
Columbus, Ohio, 43214
United States
Lutheran General Cancer Care Center
Park Ridge, Illinois, 60068
United States
Evanston Northwestern Health Care
Evanston, Illinois, 60201
United States
Lakeland Medical Center - St. Joseph
Saint Joseph, Michigan, 49085
United States
Fort Wayne Medical Oncology and Hematology, Inc.
Ft. Wayne, Indiana, 46885-5099
United States
Loyola University Medical Center
Maywood, Illinois, 60153
United States
Central Baptist Hospital
Lexington, Kentucky, 40503
United States
Cancer Care Specialists of Central Illinois, S.C.
Decatur, Illinois, 62526
United States
Columbia LaGrange Memorial Hospital
LaGrange, Illinois, 60525
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
Oncology/Hematology Associates of Central Illinois, P.C.
Peoria, Illinois, 61602
United States
Yale Comprehensive Cancer Center
New Haven, Connecticut, 06520-8028
United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0752
United States
Ingalls Memorial Hospital
Harvey, Illinois, 60426
United States
Central Illinois Hematology Oncology Center
Springfield, Illinois, 62701
United States
Michiana Hematology/Oncology P.C.
South Bend, Indiana, 46617
United States
Cancer Centers of the Carolinas
Greenville, South Carolina, 29605
United States
Additional Information:
Study ID Numbers: CDR0000067355; UCCRC-10015,NCI-T99-0010
Study Start Date: December 2000
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004127
Other Adenocarcinoma Of The Stomach Studies:
1. Erlotinib in Treating Patients With Locally Advanced or Metastatic Stomach Cancer or Gastroesophageal Junction Cancer
2. Aminocamptothecin in Treating Patients With Stomach Cancer or Cancer of the Esophagus
3. Gemcitabine and Irinotecan in Treating Patients With Metastatic or Recurrent Cancer of the Esophagus
4. Antineoplaston Therapy in Treating Patients With Stomach Cancer
5. Vaccine Therapy in Treating Patients With Metastatic or Recurrent Cancer
Related Studies:
Other adenocarcinoma of the stomach Clinical Trials
Other Illinois Clinical Trials
Other Chicago Clinical Trials
Oxaliplatin With Fluorouracil and Leucovorin in Treating Patients With Recurrent or Metastatic Cancer of the Esophagus or Stomach
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