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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Gastric Cancer

Intervention / Treatment
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* Drug: capecitabine
* Drug: oxaliplatin
* Drug: tegafur-gimeracil-oteracil potassium


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent gastric cancer, adenocarcinoma of the stomach, stage IIIA gastric cancer, stage IIIB gastric cancer, stage IIIC gastric cancer, stage IV gastric cancer