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A Phase I/II, Open-Label, Nonrandomized, Dose-Finding Safety, Tolerance, Pharmacokinetic, and Efficacy Study of Orally Administered S-1 in Combination With Cisplatin in Patients With Advanced Gastric Cancer

Phase 1/Phase 2
18 Years
Not Enrolling
Gastric Cancer

Thank you

Trial Information

A Phase I/II, Open-Label, Nonrandomized, Dose-Finding Safety, Tolerance, Pharmacokinetic, and Efficacy Study of Orally Administered S-1 in Combination With Cisplatin in Patients With Advanced Gastric Cancer

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.

Inclusion 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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


United States: Food and Drug Administration

Study ID:

TPU-S1101; ID02-694



Start Date:

October 2003

Completion Date:

May 2006

Related Keywords:

  • Gastric Cancer
  • gastric cancer
  • phase 2 clinical trial
  • Stomach Neoplasms



MD Anderson Cancer Center Houston, Texas  77030-4096
Abramson Cancer Center at the University of Pennsylvania Philadelphia, Pennsylvania  19104
Straub Clinic and Hospital Honolulu, Hawaii  96813
University of Chicago Chicago, Illinois  60637
University of Southern California Norris Comprehensive Cancer Center Los Angeles, California  90089
Rosen, Lee Los Angeles, California  90025
Chong, Clayton Honolulu, Hawaii  96817
Northwestern University Robert H Lurie Comprehensive Cancer Center Chicago, Illinois  60611
Lovelace Sandia Health System Albuquerque, New Mexico  87108
University of New Mexico - Albuquerque Albuquerque, New Mexico  87131
New Mexico VA Health Care System Albuquerque, New Mexico  87108