Overview
Sequential Chemotherapy With Xelox Follows by TX to Treat Gastric Cancer
Status:
Unknown status
Unknown status
Trial end date:
1969-12-31
1969-12-31
Target enrollment:
0
0
Participant gender:
All
All
Summary
The purpose of this study is to determine whether sequential chemotherapy with capecitabine plus oxaliplatin (Xelox) followed by docetaxel plus capecitabine (TX)in unresectable gastric cancer.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Taipei Veterans General Hospital, TaiwanTreatments:
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.
- Aged > 20 years old.
- ECOG Performance Status <= 2.
- Life expectancy greater than 12 weeks.
- Adequate bone marrow function
- Adequate liver function
- Adequate renal function
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 1
month 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
- fertile men and women unless using a reliable and appropriate contraceptive method