Using Genetic Polymorphisms to Predict the Efficacy and Toxicity - A Gastric Adenocarcinoma Study

• Status: Terminated
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label, non-comparative phase II study of sequential capecitabine plus oxaliplatin followed by docetaxel plus capecitabine in patients with unresectable gastric adenocarcinoma.

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

Details

• Lead Sponsor: National Health Research Institutes, Taiwan
• Collaborators: Mackay Memorial Hospital; National Cheng-Kung University Hospital; Taipei Veterans General Hospital, Taiwan; Tri-Service General Hospital
• Treatments: Capecitabine; Docetaxel; Oxaliplatin

Criteria

Inclusion Criteria:

• Pathologically confirmed gastric adenocarcinoma.

• At least one measurable lesion in a non-irradiated area.

• No prior exposure to systemic chemotherapy for advanced gastric cancer.

• For those have adjuvant chemotherapy after a curative gastrectomy, the last dosing of previous adjuvant chemotherapy should be at least 6 months before the start of this treatment.

• Age > 20 years old.

• ECOG Performance Status 2.

• Life expectancy greater than 12 weeks.

• Adequate bone marrow function :absolutely neutrophil count 1.5 x 109/L or WBC 4 x 109/L; Hemoglobin > 9 g/dl;platelet count 100 x 109/L.

• Adequate liver function : ALT & AST 2.5 x ULN if without liver metastasis or 5 x ULN if with hepatic metastasis. Alkaline phosphatase 2.5 x ULN if without liver metastasis or 5 x ULN, if with hepatic and bone metastasis. Bilirubin < 2 x ULN

• Adequate renal function :Creatinine < 1.5 x ULN.

• Patients must be accessible for treatment and follow-up in the participating centers.

Exclusion Criteria:

• Patient who are receiving concurrent radiotherapy, chemotherapy or other experimental therapy.(Previous radiotherapy is allowable if the last dose was given more than 2 weeks before the protocol treatment).

• Major surgery within two weeks prior to entering the study.

• Patients with CNS metastasis, including clinical suspicion.

• Patients who are under active or uncontrolled infections.

• Patients who had cardiac arrhythmia or myocardial infarction history 6 months before entry.

• Patients with clinically detectable peripheral neuropathy > 2 on the CTC criteria

• Patients with concomitant illness that might be aggravated by chemotherapy.

• Patients who are pregnant or with breast feeding.

• Other concomitant or previously malignancy within 5 yrs except for in situ cervix cancer or squamous cell carcinoma of the skin treated by surgery only.

• Patients with hypersensitivity to any component of the chemotherapeutic regimen.

• Mental status is not fit for clinical trial

• Can not take study medication orally