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

Sponsor

Nanjing Sike Pharmaceutical Co., Ltd. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT00881816

Collaborator

(none)

Enrollment

Arm

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Advanced Gastric Carcinoma	Drug: Liposomal paclitaxel plus capecitabine	Phase 1

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2009

Anticipated Primary Completion Date :

Oct 1, 2009

Anticipated Study Completion Date :

Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Liposomal paclitaxel plus capecitabine	Drug: 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.

Arm

Intervention/Treatment

Experimental: Liposomal paclitaxel plus capecitabine

Drug: 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.

Outcome Measures

Primary Outcome Measures

maximum tolerated dose [6 months]

Secondary Outcome Measures

dose limiting toxicity [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.