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Irinotecan in Treating Patients With Advanced Cancer of the Stomach Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Irinotecan in Treating Patients With Advanced Cancer of the Stomach conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Irinotecan in Treating Patients With Advanced Cancer of the Stomach Clinical research trials and Irinotecan in Treating Patients With Advanced Cancer of the Stomach healthcare trials occur in a lot of 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 generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Irinotecan in Treating Patients With Advanced Cancer of the Stomach. Irinotecan in Treating Patients With Advanced Cancer of the Stomach Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Irinotecan in Treating Patients With Advanced Cancer of the Stomach clinical trial. Test subjects typically receive the most effective healthcare possible for their Irinotecan in Treating Patients With Advanced Cancer of the Stomach condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "I" Clinical Trials Conditions > Irinotecan in Treating Patients With Advanced Cancer of the Stomach  Irinotecan in Treating Patients With Advanced Cancer of the Stomach
Irinotecan in Treating Patients With Advanced Cancer of the Stomach
For Condition: diffuse adenocarcinoma of the stomach,stage 4 esophageal cancer,stage 4 gastric cancer,mixed adenocarcinoma of the stomach,Adenocarcinoma of the Esophagus,intestinal adenocarcinoma of the stomach
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , North Central Cancer Treatment Group
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients who have advanced cancer of the stomach.
Details: OBJECTIVES: I. Evaluate the response rate, survival, and toxicity of previously untreated patients with locally advanced or metastatic gastric cancer who are treated with irinotecan (CPT-11). PROTOCOL OUTLINE: This is a nonrandomized study. Patients receive irinotecan (CPT-11) by IV over 90 minutes every 3 weeks. Dosage modifications are made based on toxicity. Retreatment may be delayed another 3 weeks (for a total of 6 weeks) to allow for recovery from toxic effects. Patient is taken off study if they do not recover from toxic effects, unless cause is documented to be unrelated to CPT-11. Patients with stable disease or partial response continue on treatment until disease progression or intolerable toxicity. Patients with complete response continue on treatment for another 2 courses and then are observed. Patients are followed every 3 months for 3 years or until disease progression. PROJECTED ACCRUAL: A minimum of 21 and a maximum of 66 patients will be accrued into this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed advanced adenocarcinoma of the stomach or gastroesophageal junction beyond hope of surgical cure and not considered a candidate for potentially curative chemotherapy/radiation therapy - Measurable or evaluable disease - Tumor must be accessible for biopsy - No known central nervous system metastases or carcinomatous meningitis --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No prior chemotherapy for gastric or gastroesophageal junction cancer; No prior irinotecan (CPT-11) or other camptothecin - Endocrine therapy: Not specified - Radiotherapy: No prior abdominal or pelvic radiotherapy; No prior radiotherapy to greater than 25% of bone marrow; No prior radiotherapy to measurable or evaluable indicator lesions; At least 4 weeks since major radiotherapy (chest radiotherapy) - Surgery: At least 3 weeks since major surgery and recovered; At least 2 weeks since minor surgery and recovered - Other: No other concurrent investigational agents --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-2 - Life expectancy: At least 12 weeks - Hematopoietic: Absolute granulocyte count at least 1,500/mm3; Platelet count at least 150,000/mm3; Hemoglobin at least 9.0 mg/dL (transfusion allowed) - Hepatic: Bilirubin no greater than upper limit of normal (ULN), regardless of liver involvement secondary to tumor; AST no greater than 3 times ULN - Renal: Creatinine no greater than 1.5 times ULN - Cardiovascular: No unstable angina; No uncontrolled high blood pressure; No active congestive heart failure; No myocardial infarction in the last 6 months; No serious uncontrolled cardiac arrhythmia; No New York Heart Association Class III or IV heart disease - Pulmonary: No interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung; No pleural effusion or ascites, which cause respiratory compromise (at least Grade 2 dyspnea) - Other: No active or uncontrolled infection; No prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, adequately treated noninvasive carcinomas, or other cancer from which the patient has been disease free for at least 5 years; Not pregnant or nursing; Adequate contraception required of all fertile patients
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RichardGoldberg, Study Chair, North Central Cancer Treatment Group
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, 57104
United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68131
United States
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, 17822-2001
United States
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1
Canada
CentraCare Clinic
St. Cloud, Minnesota, 56303
United States
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, 85259-5404
United States
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61602
United States
Medcenter One Health System
Bismark, North Dakota, 58501
United States
Rapid City Regional Hospital
Rapid City, South Dakota, 57709
United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, 52403-1206
United States
Siouxland Hematology-Oncology
Sioux City, Iowa, 51101-1733
United States
Altru Health Systems
Grand Forks, North Dakota, 58201
United States
CCOP - Merit Care Hospital
Fargo, North Dakota, 58122
United States
CCOP - Wichita
Wichita, Kansas, 67214-3882
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309-1016
United States
CCOP - Duluth
Duluth, Minnesota, 55805
United States
Additional Information:
Study ID Numbers: CDR0000065905; NCCTG-964152
Study Start Date: April 2000
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003137
Other Intestinal Adenocarcinoma Of The Stomach Studies:
1. Irinotecan in Treating Patients With Advanced Cancer of the Stomach
2. Surgery With or Without Combination Chemotherapy in Treating Patients With Stomach Cancer
Related Studies:
Other intestinal adenocarcinoma of the stomach Clinical Trials
Other Minnesota Clinical Trials
Other Duluth Clinical Trials
Irinotecan in Treating Patients With Advanced Cancer of the Stomach
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