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

August 6, 2009 updated by: Taiho Oncology, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

41

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taiho Oncology, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2003

Primary Completion (Actual)

March 1, 2006

Study Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

November 10, 2003

First Submitted That Met QC Criteria

November 12, 2003

First Posted (Estimate)

November 13, 2003

Study Record Updates

Last Update Posted (Estimate)

August 7, 2009

Last Update Submitted That Met QC Criteria

August 6, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TPU-S1101; ID02-694

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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