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

NCT00639522 | Unknown Phase 1

• 1 other identifier: LPS-GC-01-2008
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastric Carcinoma

Keywords

Liposomal paclitaxel; Maximum tolerated dose; Pharmacokinetics; Gastric carcinoma

Outcome Measures

Primary Outcomes (1)

• Dose limiting toxicity

  6 weeks

Secondary Outcomes (1)

• Pharmacokinetics

  48 hours

Study Arms (1)

A

EXPERIMENTAL

Drug: Liposomal paclitaxel and capecitabine

Interventions

Liposomal paclitaxel and capecitabine DRUG

Patients will be given Liposomal paclitaxel intravenously in 3 hours with the dose of 175mg/m2、185mg/m2、195mg/m2、 200mg/m2、205mg/m2 and so on ,at the first day of chemotherapy. Capecitabine will be given on d1 to d14 with the dose of 185mg/m2、200mg/m2 or d8 to d21 with the dose of 175mg/m2、195mg/m2、205mg/m2 .Cycle duration will be 21 days. Each patient will receive 2 cycles of therapy. Only in the first cycle blood samples will be taken on 16 points in 48 hours after the infusion of liposomal paclitaxel.

A

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Nanjing Sike Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Cancer Hospital,Chinese Academy of Medical Science

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Jinwan Wang, Doctor

  Cancer Hospital Chinese Academy of Medical Science

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jinwan Wang, Doctor

CONTACT

086-010-87788842; hsunyk@tom.com

Chi Yihebali, Doctor

CONTACT

086-010-87788118; yihebalichi@yahoo.com.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 14, 2008
• First Posted: March 20, 2008
• Study Start: May 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: December 1, 2009
• Last Updated: April 15, 2009

Record last verified: 2009-04

Locations

CN (1)