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A Phase I Clinical Trial to Investigate the Maximum Tolerated Dose and Pharmacokinetics of Liposomal Paclitaxel With/Without Capecitabine in Chinese Cancer Patients With Advanced Gastric Carcinoma.


Phase 1
18 Years
65 Years
Open (Enrolling)
Both
Gastric Carcinoma

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Trial Information

A Phase I Clinical Trial to Investigate the Maximum Tolerated Dose and Pharmacokinetics of Liposomal Paclitaxel With/Without Capecitabine in Chinese Cancer Patients With Advanced Gastric Carcinoma.


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.


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;

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Dose limiting toxicity

Outcome Time Frame:

6 weeks

Safety Issue:

Yes

Principal Investigator

Jinwan Wang, Doctor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Hospital, Chinese Academy of Medical Science

Authority:

China: Ministry of Health

Study ID:

LPS-GC-01-2008

NCT ID:

NCT00639522

Start Date:

May 2008

Completion Date:

December 2009

Related Keywords:

  • Gastric Carcinoma
  • Liposomal paclitaxel
  • Maximum tolerated dose
  • Pharmacokinetics
  • Gastric carcinoma
  • Carcinoma
  • Stomach Neoplasms

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