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

NCT ID: NCT00881816

Last Updated: 2009-04-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2009-12-31

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 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.

Conditions

Advanced Gastric Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Liposomal paclitaxel plus capecitabine

Group Type: EXPERIMENTAL

Liposomal paclitaxel plus capecitabine

Intervention Type: DRUG

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.

Interventions

Liposomal paclitaxel plus capecitabine

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.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing Sike Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Cancer Hospital of Fudan University

Principal Investigators

Jin Li, Dr.

Role: PRINCIPAL_INVESTIGATOR

Cancer Hospital of Fudan University

Other Identifiers

NJSK-LPS-PH I-02

Identifier Type: -

Identifier Source: secondary_id

LPS-GC-02-2008

Identifier Type: -

Identifier Source: org_study_id