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

Advanced Gastric Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00881816
• Other study ID #: LPS-GC-02-2008
• Secondary ID: NJSK-LPS-PH I-02
• Status: Active, not recruiting
• Phase: Phase 1
• First received: April 14, 2009
• Last updated: April 14, 2009
• Start date: April 2009
• Est. completion date: December 2009

Study information

• Verified date: April 2009
• Source: Nanjing Sike Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: December 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Gastric Carcinoma
• Carcinoma
• Stomach Neoplasms

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Sike Pharmaceutical Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	maximum tolerated dose		6 months	Yes
Secondary	dose limiting toxicity		6 months	Yes