An open study comparing the efficacy of S-1 and Cisplatin in combination versus 5-FU and Cisplatin in patients with Gastric cancer not previouslytreated with chemotherapy.
- Conditions
- Metastatic Diffuse Gastric CancerMedDRA version: 14.1Level: PTClassification code 10063916Term: Metastatic gastric cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2009-016019-39-BE
- Lead Sponsor
- Taiho Pharma USA, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 500
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 by Central Pathology Review, unresectable (at the time of screening
for study eligibility), metastatic diffuse gastric cancer including carcinoma of the gastroesophageal
junction as defined in Appendix F (Pathology Central Review: Histologic Criteria).
Patients must only be randomized after central pathology review has confirmed diffuse histologic type. Gastro-esophageal junction involvement must be documented by endoscopic, radiologic, surgical or pathology report.
3. Has had no prior chemotherapy for gastric cancer; however, adjuvant and/or neo-adjuvant
chemotherapy is permitted if more than 12 months have elapsed between the end of adjuvant or
neo-adjuvant therapy and first recurrence.
4. Has a life expectancy of at least 3 months.
5. Is able to take medications orally and without being crushed or removed from the capsule and given through any form of feeding tube.
6. Is =18 years of age.
7. First dose of study medication will be at least 3 weeks from prior major surgery.
8. First dose of study medication will be at least 4 weeks from prior radiotherapy.
9. Has an ECOG performance status 0 to 1 (see Appendix A).
10. Has adequate organ function as defined by the following criteria:
a. Aspartate aminotransferase (AST; SGOT) and alanine aminotransferase (ALT; SGPT) =2.5 ×
upper limit of normal (ULN); if liver function abnormalities are due to underlying liver
metastasis, AST (SGOT) and ALT (SGPT) =5 × ULN.
b. Total serum bilirubin of =1.5 × ULN.
c. Absolute neutrophil count of =1,500/mm3 (ie, =1.5 × 109/L by International Units [IU]).
d. Platelet count =100,000/mm3 (IU: =100 × 109/L).
e. Hemoglobin value of =9.0 g/dL based on measurements obtained prior to any transfusions during the Baseline period.
f. Creatinine clearance (CrCl) =60 mL/min.
11. Is willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
12. Women of childbearing potential must have a negative pregnancy test (urine or serum) prior to
randomization. Females and males must agree to adequate birth control if conception is possible during the study; and males and females must agree to adequate birth control for up to 6 months
after the discontinuation of study medication.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100
Exclude a patient from this study if any of the following conditions are observed:
1. Has only the following type(s) of non-measurable lesion(s):
a. Ascites, pleural or pericardial effusions.
b. Previously irradiated lesions not in progression.
2. Has had treatment with any of the following within the specified time frame prior to study medication administration:
a. Any prior chemotherapy or any previous therapy for malignancy other than gastric cancer,
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. Treatment with any investigational agent within 30 days of randomization.
d. Prior cisplatin as neo-adjuvant and/or adjuvant chemotherapy with cumulative dose
>360 mg/m2.
e. >25% of marrow-bearing bone radiated.
3. Has a serious illness or medical condition(s) including, but not limited to, the following:
a. Known acute systemic infection.
b. Known brain or leptomeningeal metastases.
c. Ascites =Grade 3 (ie, invasive intervention is indicated).
d. Other malignancies within the past 5 years, except adequately treated carcinoma-in-situ of the
cervix or non-melanoma skin cancer.
e. Myocardial infarction within the last 6 months, severe/unstable angina, congestive heart failure New York Heart Association (NYHA) class III or IV (see Appendix E);
f. Chronic nausea, vomiting, or diarrhea.
g. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
h. Any disorder that may interfere with consent and/or protocol compliance.
i. Peripheral neuropathy, Grade 2 or higher.
j. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study medication 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.
4. Has lost =10% of their body weight in the preceding 3 months at time of signed ICF.
5. Is receiving treatment with drugs interacting with S-1, 5-FU, or cisplatin (see the required washout
period before starting a patient on treatment [Section 6.6]). The following drugs are
prohibited:
a. Sorivudine, brivudine, uracil, eniluracil, cimetidine, folinic acid, ipyridamole, flucytosine, methotrexate, and nitroimidazoles, including metronidazole and misonidazole (may enhance S-1 and 5-FU activity).
b. Clozapine (may increase risk and severity of hematologic toxicity with S-1).
c. Allopurinol (may diminish 5-FU activity).
d. Ethyol (may diminish cisplatin activity [see package insert]).
6. Is a pregnant or lactating female.
7. Has known hypersensitivity to 5-FU or cisplatin.
Additional Criteria for Randomization
Immediately prior to randomization, the following criteria must be met:
1. Has not experienced =5% loss of their body weight between signed ICF and randomization;
2. Has an ECOG performance status of 0 or 1 on Cycle 1, Day 1;
3. Has no sign of infection on Cycle 1 Day 1.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method