Dose Escalation Study of Liposomal Paclitaxel With/Without Capecitabine in Patients With Advanced Gastric Carcinoma

• Status: Unknown status
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate the maximum tolerated dose and pharmacokinetics of liposomal paclitaxel with/without capecitabine in Chinese cancer patients with advanced gastric carcinoma.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nanjing Sike Pharmaceutical Co., Ltd.
• Treatments: Albumin-Bound Paclitaxel; Capecitabine; Paclitaxel

Criteria

Inclusion Criteria:

• Histologically verified gastric carcinoma of advanced stages which is unsuitable for surgery;

• No prior systemic chemotherapy with taxane at least 6 months before the recruitment;

• At least one measurable tumor according to RECIST standard, with at least one diameter ≥20mm assessed by traditional imaging technique or MRI, or with a diameter twice of the thickness of scan layer (or ≥10-16mm) under spiral CT; Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1;

• Patients who are expected to live at least 3 months;

• Obtaining informed consent;

Exclusion Criteria:

• Receiving other chemotherapy or radiotherapy during the administration;

• Symptomatic metastatic brain tumor;

• Allergy to any study medication;

• Pregnancy or breast feeding;

• Severe heart diseases;

• Uncontrolled mental diseases;

• Abnormal liver and renal functions, which are measured by AST/ALT and BUN/Cr;

• Neutrophils（ANC）<2000/μL;platelets<100，000/μL;hemoglobin（HB）<9.0 g/dL;