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

NCT00985556 | Unknown Phase 2

• 2 other identifiers: CDR0000650368YONSEI-4-2007-0296
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastric Cancer

Keywords

recurrent gastric cancer; adenocarcinoma of the stomach; stage IIIA gastric cancer; stage IIIB gastric cancer; stage IIIC gastric cancer; stage IV gastric cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

Secondary Outcomes (1)

• Time to progression

Study Arms (2)

Arm I

EXPERIMENTAL

Patients receive oral S-1 twice daily on days 1-14 and oxaliplatin IV over 2 hours on day 1.

Drug: oxaliplatin; Drug: tegafur-gimeracil-oteracil potassium

Arm II

EXPERIMENTAL

Patients receive oral capecitabine twice daily on days 1-14 and oxaliplatin as in arm I.

Drug: capecitabine; Drug: oxaliplatin

Interventions

capecitabine DRUG

Given orally

Arm II

oxaliplatin DRUG

Given IV

Arm I; Arm II

tegafur-gimeracil-oteracil potassium DRUG

Given orally

Arm I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei Cancer Center at Yonsei University Medical Center

Seoul, 120-752, South Korea

RECRUITING

Related Publications (1)

• Kang JI, Chung HC, Jeung HC, Kim SJ, An SK, Namkoong K. FKBP5 polymorphisms as vulnerability to anxiety and depression in patients with advanced gastric cancer: a controlled and prospective study. Psychoneuroendocrinology. 2012 Sep;37(9):1569-76. doi: 10.1016/j.psyneuen.2012.02.017. Epub 2012 Mar 28.

  PMID: 22459275 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Capecitabine; Oxaliplatin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals

Study Officials

• Hyun C. Chung, MD, PhD

  Yonsei University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 25, 2009
• First Posted: September 28, 2009
• Study Start: January 1, 2009
• Last Updated: October 20, 2011

Record last verified: 2009-09

Locations

KR (1)