Oxaliplatin and S-1 or Oxaliplatin and Capecitabine in Treating Patients With Recurrent, Metastatic, or Unresectable Gastric Cancer

October 19, 2011 updated by: Yonsei University

Randomized Phase II Study of S-1 (SOX) or Capecitabine (XELOX) in Combination With Oxaliplatin in Patients With Recurrent or Metastatic Gastric Cancer

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, S-1, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether giving oxaliplatin together with S-1 is more effective than giving oxaliplatin together with capecitabine.

PURPOSE: This randomized phase II trial is studying how well giving oxaliplatin together with S-1 works compared to oxaliplatin given together with capecitabine in treating patients with recurrent, metastatic, or unresectable gastric cancer.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • To evaluate the time to progression in patients with recurrent or metastatic gastric cancer treated with oxaliplatin in combination with S-1 vs capecitabine.

Secondary

  • To assess progression-free survival, overall response, disease-control rate, time-to-treatment failure, response duration, time to response, overall survival, safety, quality of life, pharmacogenetics, and psychologic distress/coping strategy.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral S-1 twice daily on days 1-14 and oxaliplatin IV over 2 hours on day 1.
  • Arm II: Patients receive oral capecitabine twice daily on days 1-14 and oxaliplatin as in arm I.

Courses in both arms repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 2 months for 6 months.

Study Type

Interventional

Enrollment (Anticipated)

130

Phase

  • Phase 2

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

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Recruiting
        • Yonsei Cancer Center at Yonsei University Medical Center
        • Contact:

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the stomach
  • Unresectable advanced disease or recurrent disease after resection
  • At least one radiographically documented (CT scan or MRI) measurable or evaluable lesion in a previously non-irradiated area according to RECIST
  • No clinical evidence of brain metastases or history of other CNS disease unless adequately treated

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Estimated life expectancy > 3 months
  • Hemoglobin ≥ 9 g/dL
  • White blood cell ≥ 4,000/µL
  • ANC ≥ 2,000/µL
  • Platelets ≥ 100,000/µL
  • Bilirubin ≤ 1.25 times upper limit of normal (ULN) (≤ 2.0 times ULN if hepatic metastasis present)
  • Serum creatinine ≤ 1.5 times ULN
  • Creatinine clearance ≥ 60 mL/min
  • AST/ALT ≤ 3.0 times ULN (≤ 5.0 times ULN if hepatic metastasis present)
  • Alkaline phosphatase ≤ 3.0 times ULN (≤ 5.0 times ULN if bone metastasis present)
  • Must have an intact gastrointestinal tract
  • Able to take oral medications
  • No medically uncontrolled severe infections or complications
  • No prior malignancy other than gastric cancer in the last 5 years except for basal cell cancer of the skin or preinvasive cancer of the cervix
  • Not pregnant or nursing
  • No neuropathy ≥ grade 2
  • No clinically relevant heart disease
  • No evidence of past medical history or psychosocial dysfunction that contraindicates the use of an investigational drug or puts the patient at risk
  • No dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent
  • No uncontrolled hepatitis B or C, chronic liver disease, or diabetes mellitus
  • No other evidence of inappropriate suspicious condition

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy for advanced or recurrent disease

    • Prior adjuvant chemotherapy allowed if finished > 6 months before start of study treatment

  • No prior therapeutic radiotherapy

    • Prior palliative radiotherapy allowed if it was not done for primary, evaluable, or intraabdominal lesions
  • No prior capecitabine or oxaliplatin
  • No other concurrent chemotherapy or radiotherapy (except localized radiotherapy for pain relief)
  • No concurrent chemically related analogues, such as warfarin, phenytoin, or allopurinol

  • No concurrent steroid therapy except as follows:

    • Prophylactic use for hypersensitivity control or antiemetic purpose allowed
    • Chronic low dose of steroid (less than methylprednisolone 20 mg or equivalent dose) allowed

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: Randomized
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I
Patients receive oral S-1 twice daily on days 1-14 and oxaliplatin IV over 2 hours on day 1.
Drug: oxaliplatin
Given IV
Drug: tegafur-gimeracil-oteracil potassium
Given orally
Experimental: Arm II
Patients receive oral capecitabine twice daily on days 1-14 and oxaliplatin as in arm I.
Drug: oxaliplatin
Given IV
Drug: capecitabine
Given orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Progression-free survival

Secondary Outcome Measures

Outcome Measure
Time to progression

Collaborators and Investigators

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

Sponsor

Yonsei University

Investigators

  • Principal Investigator: Hyun C. Chung, MD, PhD, Yonsei University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2009

Study Registration Dates

First Submitted

September 25, 2009

First Submitted That Met QC Criteria

September 25, 2009

First Posted (Estimate)

September 28, 2009

Study Record Updates

Last Update Posted (Estimate)

October 20, 2011

Last Update Submitted That Met QC Criteria

October 19, 2011

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000650368
  • YONSEI-4-2007-0296

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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