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Phase 1/2 study of S-1 and cisplatin in advanced gastric cancer Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Phase 1/2 study of S-1 and cisplatin in advanced gastric cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Phase 1/2 study of S-1 and cisplatin in advanced gastric cancer Clinical research trials and Phase 1/2 study of S-1 and cisplatin in advanced gastric cancer health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Phase 1/2 study of S-1 and cisplatin in advanced gastric cancer. Phase 1/2 study of S-1 and cisplatin in advanced gastric cancer Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Phase 1/2 study of S-1 and cisplatin in advanced gastric cancer clinical trial. Subjects frequently get the best healthcare possible for their Phase 1/2 study of S-1 and cisplatin in advanced gastric cancer condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Phase 1/2 study of S-1 and cisplatin in advanced gastric cancer  Phase 1/2 study of S-1 and cisplatin in advanced gastric cancer
Phase 1/2 study of S-1 and cisplatin in advanced gastric cancer
For Condition: Gastric Cancer
Status: Recruiting
Sponsor(s): Taiho Pharma USA, Inc. ,
Synopsis: The purpose of the phase 1 portion of the study is to determine the safe dose of S-1 and cisplatin that can be administered in gastric cancer patients. The purpose of the phase 2 portion of the study is to determine the antitumor activity of the S-1 and cisplatin regimen established from phase 1 in patients with advanced gastric cancer.
Details: S-1 is an oral fluoropyrimidine which combines tegafur (a 5-FU prodrug) with two classes of modulators which: - inhibit dihydropyrimidine dehydrogenase (DPD) and - block phosphorylation of 5-FU in gastrointestinal tissues. S-1 is designed to enhance the the clinical utility of an oral fluoropyrimidine while ameliorating the disadvantage of gastrointestinal toxicity. 5-Fu and cisplatin have been used as a standard treatment in gastric cancer and preliminary data indicate that S-1 plus cisplatin may result in superior tolerability and efficacy in advanced gastric cancer. S-1 is currently approved in Japan for treatment of gastric cancer and head and neck cancer.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria - Has histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction - Has advanced, unresectable cancer at the time of study entry - Has measurable disease as defined by RECIST criteria, i.e., lesions that can be accurately measured in at least one dimension with the longest diameter 20 mm using conventional techniques or 10 mm using spiral CT scan - Is at least 3 weeks post-gastrectomy surgery - Has not received prior chemotherapy for their cancer (adjuvant therapy is permitted and does not count as prior chemotherapy). - Has performance status of 70% on the Karnofsky scale (Appendix B) - Has a predicted life expectancy of 12 weeks - Has an absolute granulocyte count of 1,500/mm3 - Has a platelet count 100,000/mm3 - Has a hemoglobin of 9.0 g/dL - Has a bilirubin of 1.5 times the ULN - Has transaminases 2.5 times the ULN except for patients with liver metastasis who may have transaminases 5 times the ULN - Has a creatinine ULN and calculated creatinine 60 mL/min - According to the judgment of the Investigator, the patient has recovered from all previous anti-cancer treatment-related toxicities to at least Grade 1 (see exceptions above) - Has stopped all previous investigational drugs at least 4 weeks prior to treatment with S-1 and cisplatin. - Is able to take medications orally - Female patients of childbearing potential who are not pregnant and who use acceptable means of contraception while on study and for an additional 30 days after the last dose of study medication. Male patients must use adequate contraception. Exclusion Criteria - Has relapsed within 6 months from the end of adjuvant therapy - Has known brain or leptomeningeal metastases. - Has any other serious illness or medical condition(s) including, but not limited to, the following: • uncontrolled congestive heart failure, angina pectoris, arrhythmias, or hypertension ; or any significant medical condition that is a contraindication for chemotherapy • concurrent malignancy other than gastric cancer except adequately treated carcinoma-in-situ of the cervix or non-melanoma skin cancer • active infection • gastrointestinal disorder, including malabsorption, chronic nausea and vomiting, chronic diarrhea • unstable diabetes mellitus • psychiatric disorder that may interfere with consent and/or protocol compliance • known neuropathy (including hearing loss) at baseline of Grade 2 or higher (as per NCI CTC v2.0 see Appendix A) - Has known hypersensitivity to any of the constituents of the study medication - Is receiving a concomitant treatment with drugs interacting with S-1. - Is a pregnant or lactating female or who refuses to use an acceptable means of contraception. Is a male and refuses to use an acceptable means of contraception.
Total Enrollment: 41
Location and Contact Information:
Northwestern University Robert H Lurie Comprehensive Cancer Center *Not yet recruiting*
Chicago, Illinois, 60611
United States
Not yet recruiting Janet Fitzpatrick 312-695-0902
University of Southern California Norris Comprehensive Cancer Center *Not yet recruiting*
Los Angeles, California, 90089
United States
Not yet recruiting Sarah Cole 323-865-0820
MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030
United States
Recruiting Josephine Faust 713-794-1623
University of Chicago *Not yet recruiting*
Chicago, Illinois, 60637
United States
Not yet recruiting Deepti Singh 773-702-4400
Abramson Cancer Center at the University of Pennsylvania *Not yet recruiting*
Philadelphia, Pennsylvania, 19104
United States
Not yet recruiting Jacquelyn Clark 215-898-1972
Additional Information:
Study ID Numbers: TPU-S1101; ID02-694;
Study Start Date: October 2003
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00072787
Other Gastric Cancer Studies:
1. Chemotherapy and Radiation Therapy After Surgery in Treating Patients With Stomach or Esophageal Cancer
2. Vaccine Therapy in Treating Patients With Gastric Cancer, Non-Small Cell Lung Cancer, Prostate, or Ovarian Cancer
3. Oxaliplatin Plus Irinotecan in Treating Patients With Metastatic Gastrointestinal Cancer
4. Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Gastrointestinal Cancer
5. Oxaliplatin With Or Without Floxuridine and Leucovorin in Treating Patients With Metastatic Cancer of the Peritoneum
Related Studies:
Other Gastric Cancer Clinical Trials
Other Pennsylvania Clinical Trials
Other Philadelphia Clinical Trials
Phase 1/2 study of S-1 and cisplatin in advanced gastric cancer
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