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

Study Overview
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Brief Summary
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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.

Detailed Description
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There are clinical trials showed that taxane is optional for the treatment of gastric cancer. Liposomal paclitaxel has different pharmacokinetic features comparing with conventional taxane. This study is designed to find the maximum tolerated dose and dose limiting toxicity of liposomal paclitaxel combined with capecitabine in Chinese patients with advanced gastric carcinoma.

Official Title
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Phase I Clinical Study of Liposomal Paclitaxel Plus Capecitabine in Chinese Patients With Advanced Gastric Carcinoma

Conditions
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Advanced Gastric Carcinoma

Intervention / Treatment
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* Drug: Liposomal paclitaxel plus capecitabine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liposomal paclitaxel plus capecitabine<br> | Drug: Liposomal paclitaxel plus capecitabine<br>* All Patients will receive liposomal paclitaxel (with a dose of 60mg/m2,3h,ivgtt,at d1,8,15) and capecitabine (with a dose of 1600mg/m2,bid,po.,at d1-14),each cycle for 4 cycles.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maximum tolerated dose |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dose limiting toxicity |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Capecitabine, Liposomal Paclitaxel, Maximum tolerated dose, Dose limiting toxicity