Advanced gastric cancer
Conditions
Interventions
Product Name: S-1
Pharmaceutical Form: Capsule*
INN or Proposed INN: Tegafur
CAS Number: 17902-23-7
Current Sponsor code: FT
Sponsors
Taiho Pharma USA, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A patient must meet all of the following inclusion criteria to be eligible for enrollment in this study: 1. Has given written informed consent. 2. Has histologically confirmed, unresectable, locally advanced (Stage IV) or metastatic gastric cancer, including adenocarcinoma of the gastro-esophageal junction. 3. Has measurable or evaluable but non-measurable disease, defined as follows: (a) Measurable Disease – Patients with measurable disease as defined by RECIST criteria, ie, the presence of at least one measurable lesion. A measurable lesion is one that can be accurately measured in at least one dimension with the longest diameter = 20 mm using conventional techniques or = 10 mm using spiral Computed Tomography (CT) scan. Locally recurrent disease (other than primary) is accepted if there is at least one measurable lesion (ie, peritoneal mass, lymph node, etc). (b). Evaluable but Non-measurable Disease – Patients with all lesions below the limits defined above for measurable disease (ie, longest diameter =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: A patient will be excluded from this study if he/she does not fulfill the inclusion criteria, or if any of the following conditions are observed: 1. Has had treatment with any of the following within the specified time frame prior to study drug administration: (a) Any prior palliative chemotherapy or any previous therapy for malignancy, including any chemotherapy, immunotherapy, biologic or hormonal therapy, within the past 5 years. (b) Adjuvant or neo-adjuvant therapy within the past 12 months. (c) Concurrent treatment with an investigational anti-cancer agent. (d) Prior cisplatin as neo-adjuvant and/or adjuvant chemotherapy with cumulative dose > 300 mg/m 2. (e) > 25% of marrow-bearing bone radiated. (f) Concurrent treatment with an investigational agent or within 30 days from randomization. (g) Current enrollment in another clinical study. 2. Has a serious illness or medical condition(s) including, but not limited to, the following: (a) Known brain or leptomeningeal metastases. (b) Uncontrolled ascites requiring drainage at least twice a week. (c) Other malignancies within the past 5 years, except adequately treated carcinoma-in-situ of the cervix or non-melanoma skin cancer. (d) Myocardial infarction within the last 6 months, severe/unstable angina, congestive heart failure New York Heart Association (NYHA) class III or IV (see Appendix F of the Protocol). (e) Chronic nausea, vomiting, or diarrhea. (f) Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness. (g) Psychiatric disorder that may interfere with consent and/or protocol compliance. (h) Known neuropathy, Grade 2 or higher. (i) Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the Investigator would make the patient inappropriate for entry into this study. 3. Is receiving concomitant treatment with drugs interacting with S-1. The following drugs are prohibited because there may be an interaction with S-1: (a) Sorivudine, uracil, cimetidine, folinic acid, and dipyridamole (may enhance S-1 activity). (b) Allopurinol (may diminish S-1 activity). (c) Phenytoin (S-1 may enhance phenytoin activity). (d) Flucytosine, a fluorinated pyrimidine antifungal agent (may enhance S-1 activity). 4. Is receiving concomitant treatment with drugs interacting with 5-FU. The following drugs are prohibited because there may be an interaction with 5-FU: (a) Sorivudine, uracil, cimetidine, folinic acid, and dipyridamole (may enhance 5-FU activity). (b) Allopurinol (may diminish 5-FU activity). (c) Phenytoin (5-FU may enhance phenytoin activity). 5. Is receiving concomitant treatment with drugs interacting with cisplatin. The following drugs are prohibited because there may be an interaction with cisplatin: (a) Phenytoin (cisplatin may diminish phenytoin activity).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the Overall Survival (OS) of S-1/cisplatin therapy (experimental arm) to 5-FU/cisplatin therapy (control arm) in patients with advanced gastric cancer.; Secondary Objective: To compare the Overall Response Rate of S-1/cisplatin therapy to 5-FU/cisplatin therapy; To compare other parameters of antitumor activity of S-1/cisplatin therapy to 5-FU/cisplatin therapy; To assess the qualitative and quantitative toxicity and reversibility of toxicity of each treatment regimen; To evaluate the Patient Reported Outcomes, clinical benefit, and time to treatment failure of each treatment arm; To investigate the relationship between S-1 and 5-FU plasma levels and safety and efficacy parameters (optional); Please refer to the protocol for optional objectives, for centers who are able and willing to participate. ;Primary end point(s): Overall Survival (OS) | — |
Countries
Belgium, Czech Republic, Estonia, Germany, Hungary, Italy, Spain, United Kingdom
Outcome results
None listed