Dose Escalation Study of Liposomal Paclitaxel Plus Capecitabine in Chinese Patients With Advanced Gastric Carcinoma

• Status: Unknown status
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the maximum tolerated dose and dose limiting toxicity of liposomal paclitaxel plus capecitabine in Chinese patients with advanced gastric carcinoma.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nanjing Sike Pharmaceutical Co., Ltd.
• Treatments: Albumin-Bound Paclitaxel; Capecitabine; Paclitaxel

Criteria

Inclusion Criteria:

• Age: 18 to 75

• Histologically or cytologically documented gastric adenocarcinoma and esophagus-gastro adenocarcinoma of metastatic or advanced stages with/without measurable tumor according to RECIST standard

• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1

• Patients who are expected to live at least 3 months

• No prior systemic chemotherapy with advanced stereo- tumor before the recruitment(recidivist/ metastatic without perioperative chemotherapy at least 6m)

• No Previous anaphylactic reaction to hormone

• Obtaining informed consent

• Patients may comply with the study protocol

• Laboratory tests: Absolute neutrophil count (ANC) ≥2,000/mm³, Platelet count ≥100,000/mm³, Hemoglobin ≥9.0 g/dL, Serum creatinine≤1.5 x the institutional upper limit of normal (ULN), Creatinine clearance≥50ml/min，Total bilirubin≤1.5 x the institutional upper limit of normal (ULN), Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5 x ULN. In the case of known liver metastasis, ALT and AST（SGOT） ≤1.5 x ULN.

Exclusion Criteria:

• Active uncontrolled central nervous system metastasis

• No adequate organ function or known disease :

• myocardial infarction

• active heart disease

• neuropathy or mental diseases including dementia or epilepsy

• blind、deaf、dumb or extremity disability

• known infection

• active diffuse intravascular coagulation

• known infection with hepatitis virus

• Pregnant or nursing,fertile patients would not use effective contraception during study treatment

• Prior clinically significant gastrointestinal tract disease , that would influence obviously capecitabine to absorb,including the ability to swallow by the attending physician

• No other active malignancies except that in complete remission with squamous cell carcinoma in situ of the cervix or anus, completely resected basal cell carcinoma, or no recrudescence for at least 2 year from the time a response was first documented

• Having other study medication within 4w

• Having radiation therapy or operation within 4w

• Any non-remission toxicity ≥ CTC 1 in prior anticancer therapy(including radiation therapy) (except alopecie and hemoglobin)

• Peripheral nerve disease ≥ 2

• Previous anaphylactic reaction to Capecitabine and Paclitaxel or diluents bases

• Absence of dihydropyrimidine dehydrogenase

• Patients not suitable determined by the attending physician.