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Dose Escalation Study of Liposomal Paclitaxel Plus Capecitabine in Chinese Patients With Advanced Gastric Carcinoma

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ClinicalTrials.gov Identifier: NCT00881816
Recruitment Status : Unknown
Verified April 2009 by Nanjing Sike Pharmaceutical Co., Ltd..
Recruitment status was:  Active, not recruiting
First Posted : April 15, 2009
Last Update Posted : April 15, 2009
Sponsor:
Information provided by:
Nanjing Sike Pharmaceutical Co., Ltd.

April 14, 2009
April 15, 2009
April 15, 2009
April 2009
October 2009   (Final data collection date for primary outcome measure)
maximum tolerated dose [ Time Frame: 6 months ]
Same as current
No Changes Posted
dose limiting toxicity [ Time Frame: 6 months ]
Same as current
Not Provided
Not Provided
 
Dose Escalation Study of Liposomal Paclitaxel Plus Capecitabine in Chinese Patients With Advanced Gastric Carcinoma
Phase I Clinical Study of Liposomal Paclitaxel Plus Capecitabine in Chinese Patients With Advanced Gastric Carcinoma
The purpose of this study is to determine the maximum tolerated dose and dose limiting toxicity 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.
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Advanced Gastric Carcinoma
Drug: Liposomal paclitaxel plus capecitabine
All Patients will receive liposomal paclitaxel (with a dose of 60mg/m2,3h,ivgtt,at d1,8,15) and capecitabine (with a dose of 1600mg/m2,bid,po.,at d1-14),each cycle for 4 cycles.
Experimental: Liposomal paclitaxel plus capecitabine
Intervention: Drug: Liposomal paclitaxel plus capecitabine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
15
Same as current
December 2009
October 2009   (Final data collection date for primary outcome measure)

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 physician
  • 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.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00881816
LPS-GC-02-2008
NJSK-LPS-PH I-02
No
Not Provided
Not Provided
Dr. Li Jin, Cancer Hospital of Fudan University
Nanjing Sike Pharmaceutical Co., Ltd.
Not Provided
Principal Investigator: Jin Li, Dr. Cancer Hospital of Fudan University
Nanjing Sike Pharmaceutical Co., Ltd.
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP