Status:
UNKNOWN
Dose Escalation Study of Liposomal Paclitaxel Plus Capecitabine in Chinese Patients With Advanced Gastric Carcinoma
Lead Sponsor:
Nanjing Sike Pharmaceutical Co., Ltd.
Conditions:
Advanced Gastric Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief 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.
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00881816
Start Date
April 1 2009
End Date
December 1 2009
Last Update
April 15 2009
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