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

Phase 1
18 Years
75 Years
Open (Enrolling)
Advanced Gastric Carcinoma

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Trial Information

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

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.

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

- 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.

Type of Study:


Study Design:

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

Outcome Measure:

maximum tolerated dose

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Jin Li, Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Hospital of Fudan University


China: Ministry of Health

Study ID:




Start Date:

April 2009

Completion Date:

December 2009

Related Keywords:

  • Advanced Gastric Carcinoma
  • Liposomal Paclitaxel
  • Capecitabine
  • Maximum tolerated dose
  • Dose limiting toxicity
  • Carcinoma
  • Stomach Neoplasms