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Combination Chemotherapy Followed by Surgery in Treating Patients With Stomach Cancer 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 Combination Chemotherapy Followed by Surgery in Treating Patients With Stomach Cancer conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Combination Chemotherapy Followed by Surgery in Treating Patients With Stomach Cancer Clinical research trials and Combination Chemotherapy Followed by Surgery in Treating Patients With Stomach Cancer 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 Combination Chemotherapy Followed by Surgery in Treating Patients With Stomach Cancer. Combination Chemotherapy Followed by Surgery in Treating Patients With Stomach Cancer 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 Combination Chemotherapy Followed by Surgery in Treating Patients With Stomach Cancer clinical trial. Test subjects typically receive the most effective healthcare possible for their Combination Chemotherapy Followed by Surgery in Treating Patients With Stomach Cancer 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 > "C" Clinical Trials Conditions > Combination Chemotherapy Followed by Surgery in Treating Patients With Stomach Cancer  Combination Chemotherapy Followed by Surgery in Treating Patients With Stomach Cancer
Combination Chemotherapy Followed by Surgery in Treating Patients With Stomach Cancer
For Condition: stage 3 gastric cancer,stage 1 gastric cancer,stage 2 gastric cancer,stage 4 gastric cancer
Status: Recruiting
Sponsor(s): Kaplan Cancer Center , National Cancer Institute (NCI)
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 and combining chemotherapy with surgery may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of irinotecan and cisplatin followed by surgery, floxuridine, and cisplatin in treating patients who have stomach cancer.
Details: OBJECTIVES: - Determine the complete and partial response rates and time to treatment failure in patients with advanced gastric cancer treated with neoadjuvant irinotecan and cisplatin followed by surgery then intraperitoneal floxuridine and cisplatin. - Determine the rate of potentially curative surgery in patients receiving this regimen. - Determine the toxicity and tolerance of this regimen in these patients. OUTLINE: Patients receive cisplatin IV and irinotecan IV once a week for 4 weeks. This course is repeated 2 weeks later. Patients who achieve complete or partial remission or stable disease undergo resection 4 weeks after the last chemotherapy dose. Patients with no residual macroscopic disease begin adjuvant intraperitoneal (IP) chemotherapy 1 week after surgery. Chemotherapy consists of floxuridine IP over 30 minutes on days 1-3 and days 22-24 and cisplatin IP on days 3 and 24. PROJECTED ACCRUAL: A total of 18-33 patients will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically proven, previously untreated gastric cancer - Stage IB, II, III, or IV (T3-4, N0 OR any T, N1-2, M0) - No metastases PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - SWOG 0-2 Life expectancy: - Not specified Hematopoietic: - WBC at least 4000/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 9 g/dL Hepatic: - Bilirubin less than 2 mg/dL - SGOT/SGPT no greater than 2 times upper limit of normal (ULN) - Alkaline phosphatase no greater than 3 times ULN - PT, aPTT, and TT normal - No Gilbert's disease Renal: - BUN no greater than 30 mg/dL - Creatinine no greater than 1.5 mg/dL OR - Creatinine clearance greater than 60 mL/min Cardiovascular: - No myocardial infarction within the past 3 months - No congestive heart failure requiring therapy Other: - No other invasive malignancy in the past 5 years except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix - No active or uncontrolled infection - HIV negative - No other severe concurrent disease - No psychiatric disorders that would preclude compliance - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior chemotherapy for gastric cancer Endocrine therapy: - Not specified Radiotherapy: - No prior radiotherapy for gastric cancer Surgery: - No prior surgery for gastric cancer - No emergent need for surgery for gastrointestinal obstruction, perforation, or hemorrhage
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HowardHochster, Study Chair, Kaplan Cancer Center
NYU School of Medicine's Kaplan Comprehensive Cancer Center *Recruiting*
New York City, New York, 10016
United States
Recruiting Howard Hochster 212-652-1912
Additional Information:
Study ID Numbers: CDR0000067322; NYU-9822,P-UPJOHN-647597196,NCI-G99-1594
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004103
Other Stage 2 Gastric Cancer Studies:
1. Surgery With or Without Combination Chemotherapy in Treating Patients With Cancer of the Esophagus
2. Chlorambucil Compared With No Further Therapy Following Anti- Helicobacter Therapy in Treating Patients With Low-Grade Lymphoma of the Stomach
3. Chemotherapy and Radiation Therapy in Treating Patients With Stomach Cancer
4. Oxaliplatin and Fluorouracil Plus Radiation Therapy in Treating Patients With Primary Esophageal or Stomach Cancer
5. Combination Chemotherapy Followed by Surgery in Treating Patients With Stomach Cancer
Related Studies:
Other stage 2 gastric cancer Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Combination Chemotherapy Followed by Surgery in Treating Patients With Stomach Cancer
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