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Phase 1/2 Study of S-1 and Cisplatin in Advanced Gastric Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00072787
Recruitment Status : Completed
First Posted : November 13, 2003
Last Update Posted : August 7, 2009
Information provided by:
Taiho Oncology, Inc.

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: S-1 Drug: cisplatin Phase 1 Phase 2

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 41 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2003
Actual Primary Completion Date : March 2006
Actual Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
Drug Information available for: Cisplatin

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00072787

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

Layout table for additonal information Identifier: NCT00072787     History of Changes
Other Study ID Numbers: TPU-S1101; ID02-694
First Posted: November 13, 2003    Key Record Dates
Last Update Posted: August 7, 2009
Last Verified: August 2009

Keywords provided by Taiho Oncology, Inc.:
gastric cancer
phase 2 clinical trial

Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Antineoplastic Agents