Docetaxel, Oxaliplatin and S-1 (DOS) for Advanced Gastric Cancer

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the efficacy of combination of docetaxel, oxaliplatin, and S-1 (DOS) in the treatment of advanced gastric cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hallym University Medical Center
• Collaborators: Asan Medical Center; Sanofi
• Treatments: Docetaxel; Oxaliplatin

Criteria

Inclusion Criteria:

• Histologically confirmed gastric adenocarcinoma, initially diagnosed or recurred

• Unresectable, locally advanced or metastatic

• At least one uni-dimensional measurable lesion by RECIST criteria

• Age 18 to 70 years old

• ECOG performance status ≤2

• Estimated life expectancy ≥3 months

• Adequate bone marrow function (WBCs ≥4,000/µL or absolute neutrophil count ≥1,500/µL, platelets ≥100,000/µL),

• Adequate kidney function (creatinine <1.5 mg/dL)

• Adequate liver function (bilirubin ≤1.8 mg/dL, transaminase levels <2 times the upper normal limit

• Written informed consent

Exclusion Criteria:

• Other tumor type than adenocarcinoma

• Previous history of chemotherapy (exception: adjuvant chemotherapy)

• Presence of CNS metastasis, psychosis, or seizure

• Obvious bowel obstruction

• Evidence of serious gastrointestinal bleeding

• Peripheral neuropathy (NCI CTC >= Grade I)

• Past or concurrent history of neoplasm other than gastric adenocarcinoma, except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix uteri

• Pregnant or lactating women, women of childbearing potential not employing adequate contraception

• Other serious illness or medical conditions