Overview

Sequential Chemotherapy With Xelox Follows by TX to Treat Gastric Cancer

Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
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 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Taipei Veterans General Hospital, Taiwan
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.

- 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