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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Nanjing Sike Pharmaceutical Co., Ltd..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Nanjing Sike Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00881816
First received: April 14, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Advanced Gastric Carcinoma
Drug: Liposomal paclitaxel plus capecitabine
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Clinical Study of Liposomal Paclitaxel Plus Capecitabine in Chinese Patients With Advanced Gastric Carcinoma

Resource links provided by NLM:


Further study details as provided by Nanjing Sike Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • maximum tolerated dose [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • dose limiting toxicity [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 15
Study Start Date: April 2009
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Liposomal paclitaxel plus capecitabine 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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00881816

Sponsors and Collaborators
Nanjing Sike Pharmaceutical Co., Ltd.
Investigators
Principal Investigator: Jin Li, Dr. Cancer Hospital of Fudan University
  More Information

No publications provided

Responsible Party: Dr. Li Jin, Cancer Hospital of Fudan University
ClinicalTrials.gov Identifier: NCT00881816     History of Changes
Other Study ID Numbers: LPS-GC-02-2008, NJSK-LPS-PH I-02
Study First Received: April 14, 2009
Last Updated: April 14, 2009
Health Authority: China: Ministry of Health

Keywords provided by Nanjing Sike Pharmaceutical Co., Ltd.:
Liposomal Paclitaxel
Capecitabine
Maximum tolerated dose
Dose limiting toxicity

Additional relevant MeSH terms:
Carcinoma
Stomach Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Paclitaxel
Capecitabine
Fluorouracil
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 29, 2014