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

Nanjing Sike Pharmaceutical

Status and phase: Unknown; Phase 1

Conditions: Gastric Carcinoma

Treatments: Drug: Liposomal paclitaxel and capecitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00639522

LPS-GC-01-2008

Details and patient eligibility

About

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.

Full description

The maximum tolerated dose (MTD) and pharmacokinetics of a new formulation of taxane (liposomal paclitaxel) have never been studied in Chinese cancer patients, either alone or with capecitabine .This clinical trial is designed to find out the MTD and pharmacokinetics of liposomal paclitaxel with a beginning dose of 175mg/m2 with/without Capecitabine in Chinese patients with advanced gastric carcinoma.

Enrollment: 18 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

18 participants in 1 patient group

A

Experimental group

Treatment:

Drug: Liposomal paclitaxel and capecitabine