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An Open-Label Multicenter, Randomized, Phase 3 Study of S-1 in Combination With Cisplatin Against 5-Fu in Combination W/ Cisplatin in Patients W/ Advanced Gastric Cancer Previously Untreated W/ Chemotherapy for Advanced Disease

Phase 3
18 Years
Not Enrolling
Gastric Cancer

Thank you

Trial Information

An Open-Label Multicenter, Randomized, Phase 3 Study of S-1 in Combination With Cisplatin Against 5-Fu in Combination W/ Cisplatin in Patients W/ Advanced Gastric Cancer Previously Untreated W/ Chemotherapy for Advanced Disease

Inclusion Criteria:

A patient must meet all of the following inclusion criteria to be eligible for enrollment
in this study:

- Has given written informed consent

- Has histologically confirmed, unresectable, locally advanced (Stage IV) or
metastatic gastric cancer, including adenocarcinoma of the gastro-esophageal junction

- Has measurable or evaluable but non-measurable disease, defined as follows:

- Measurable Disease - Patients with measurable disease as defined by RECIST
criteria, i.e., 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 (i.e. peritoneal mass, lymph
node, etc.)

- Evaluable but Non-measurable Disease - Patients with all lesions below the
limits defined above for measureable disease (i.e., longest diameter < 20 mm
with conventional techniques or < 10 mm with spiral CT) excluding those patients
with only a primary lesion and/or with only non-evaluable cancer such as bone
metastases, ascites, pleural or pericardia effusions, lymphangitic
carcinomatosis of the skin or lung, previously irradiated lesions not in
progression, or peritoneal carcinomatosis < 10 mm in diameter with conventional
imaging techniques.

- No prior palliative chemotherapy is permitted. 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. This does not qualify as 1st
line therapy.

- Is able to take medications orally

- Is >_ 18 years of age

- Is at least 3 weeks from prior major surgery

- Is at least 4 weeks from prior radiotherapy

- Has a ECOG performance status 0 to 1

- Has adequate organ function as defined by the following criteria:

- AST (SGOT) and ALT (SGPT) <_ 2.5 x ULN; if liver function abnormalities are due
to underlying liver metastasis, AST (SGOT) and ALT (SGPT) <_ 5 x ULN

- Total serum bilirubin of <_ 1.5 x ULN

- Absolute granulocyte count of >_ 1,500/mm (i.e. >_ 1.5 x 10/L by International
Units (IU)

- Platelet count >_ 100,000/mm (IU: >_ 100 x 10/L

- Hemoglobin value of >_ 9.0 g/dL

- Calculated creatinine clearance >_ 60 mL/min (Cockcroft-Gault formula)

- Is willing and able to comply with scheduled visits, treatment plans, laboratory
tests and other study procedures

Exclusion Criteria:

Exclude a patient from this study if he/she does not fulfill the inclusion criteria, or if
any of the following conditions are observed:

- Has had a treatment with any of the following within the specified timeframe prior to
study drug administration:

- Any prior palliative chemotherapy or any previous therapy for malignancy,
including any chemotherapy, immunotherapy, biologic or hormonal therapy, within
the past 5 years.

- Adjuvant or neo-adjuvant therapy within the past 12 months

- Concurrent treatment with any investigational anti-cancer agent

- Prior cisplatin as neo-adjuvant and /or adjuvant chemotherapy with cumulative
dose > 300 mg/m

- > 25% of marrow-bearing bone radiated

- Concurrent treatment with an investigational agent or within 30 days from

- Concurrent enrollment in another clinical study

- Has a serious illness or medical condition(s) including, but not limited to the

- Known brain or leptomeningeal metastases

- Uncontrolled ascites requiring drainage at least twice a week

- Other malignancies within the past 5 years, except adequately treated
carcinoma-in-situ of the cervix or non-melanoma skin cancer

- Myocardial infarction within the last 6 months, severe/unstable angina,
congestive heart failure New York Heart Association (NYHA) class III or IV

- Chronic nausea, vomiting or diarrhea

- Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome
(AIDS-related illness

- Psychiatric disorder that may interfere with consent and/or protocol compliance

- Known neuropathy, Grade 2 or higher

- 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 judgement of the Investigator would make the patient
inappropriate for entry into this study

- Is receiving concomitant treatment with drugs interacting with S-1. The following
drugs are prohibited because there may be an interaction with S-1:

- Sorivudine, uracil, cimetidine, folinic acid, and dipyridamole (may enhance S-1

- Allopurinol (may diminish S-1 activity

- Phenytoin (S-1 may enhance phenytoin activity)

- Flucytosine, a fluorinated pyrimidine antifungal agent (may enhance S-1

- Is receiving concomitant treatment with drugs interacting with 5-FU:

- Sorivudine, uracil, cimetidine, folinic acid, and dipyridamole(may enhance 5-FU

- Allopurinol (may diminish 5-FU activity)

- Phenytoin (5-FU may enhance phenytoin activity)

- Is receiving concomitant treatment with drugs interacting with cisplatin:

- Phenytoin (cisplatin may diminish phenytoin activity)

- Aminoglycosides (should be avoided within 8 days after cisplatin administration)

- Ethyol (may diminish cisplatin activity

- Is a pregnant or lactating female

- Has known hypersensitivity to 5-FU or cisplatin

- Patients with reproductive potential who refuse to use an adequate means of
contraception (including male patients)

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Median Survival

Outcome Description:

Survival was defined as the time from the date of randomization to the time of death (from any cause) for each patient.

Outcome Time Frame:

The cutoff date for survival analysis was 07 March 2008 (12 months after last patient randomized).

Safety Issue:


Principal Investigator

Fabio Benedetti, MD

Investigator Role:

Study Director

Investigator Affiliation:

Taiho Pharma USA, Inc.


United States: Food and Drug Administration

Study ID:

TPU S-1301



Start Date:

May 2005

Completion Date:

April 2008

Related Keywords:

  • Gastric Cancer
  • Gastric Cancer
  • Stomach Neoplasms



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