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Oxaliplatin With Fluorouracil and Leucovorin in Treating Patients With Recurrent or Metastatic Cancer of the Esophagus or Stomach Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about 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 devoted 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 healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as 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 allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve 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. Subjects frequently obtain the most expert healthcare possible for their Oxaliplatin With Fluorouracil and Leucovorin in Treating Patients With Recurrent or Metastatic Cancer of the Esophagus or Stomach condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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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 Esophagus Studies:
1. DX-8951f in Treating Patients With Metastatic Stomach Cancer
2. BMS-247550 in Treating Patients With Recurrent Metastatic Stomach Cancer That Has Been Previously Treated With Chemotherapy
3. Vaccine Therapy in Treating Patients With Metastatic or Recurrent Cancer
4. Assessing Quality of Life of Patients With Stomach Cancer
5. Neoadjuvant Irinotecan and Cisplatin Followed By Surgical Resection in Treating Patients With Locally Advanced Cancer of the Stomach or Gastroesophageal Junction
Related Studies:
Other Adenocarcinoma of the Esophagus Clinical Trials
Other Illinois Clinical Trials
Other Decatur Clinical Trials
Oxaliplatin With Fluorouracil and Leucovorin in Treating Patients With Recurrent or Metastatic Cancer of the Esophagus or Stomach
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