Trial | NCT00842491  Report issue

Title

Study of Endostar With Cisplatin and Capecitabine as 1st Line Treatment in the Advanced Gastric Cancer
A Phase II Study of Endostar (Recombinant Human Endostatin ®) With Cisplatin and Capecitabine (Xeloda) as 1st Line Treatment in the Advanced Gastric Cancer

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    45
The purpose of this study is to investigate whether endostar (recombinant human endostatin)with cisplatin and capecitabine (Xeloda) as 1st line treatment in the advanced gastric cancer is effective and safe.
Endostar, a recombinant human endostatin, has shown its antitumor ability in combination in NSCLC and breast cancer. But to gastric cancer, few clinical data has been reported. However, bevacizumab, an angiogenesis inhibitor was shown effective in combination with chemotherapy in advanced gastric cancer in some phase II study. So in this study, we want to explore whether endostar is also effective and safe in advanced gastric cancer. Response predictive factor is expected to be identified.
Study Started
Nov 30
2008
Primary Completion
Apr 30
2010
Study Completion
Dec 31
2010
Last Update
May 19
2015
Estimate

Drug endostar, cisplatin, capecitabine

Product 1: endostar Dosing schedule: 15mg daily dose, d1-14 Mode of administration: intravenously

Drug capecitabine

Product 2: capecitabine Dosing schedule: 1000mg/m2 bid, days 1-14, every 3 weeks Mode of administration: orally

Drug cisplatin

Product 3: cisplatin Dosing schedule: 80mg/m2, day 1 of every 3 weeks Mode of administration: intravenously

endostar+chemotherapy Experimental

Criteria 

Inclusion Criteria:

Having signed informed consent
Age 18 to 70 years old
Histologically confirmed gastric adenocarcinoma
Unresectable recurrent or metastatic disease
Previous neo-adjuvant or adjuvant treatment for gastric cancer, if applicable, more than 6 months
Previous chemotherapy with capecitabine or cisplatin, if applicable, more than 12 months.
Measurable disease according to the RECIST criteria
Karnofsky performance status ≥60
Life expectancy of ≥2 month
No prior radiotherapy except radiotherapy at non-target lesion of the study more than 4 weeks
ALT and AST<2.5 times ULN (≤5 times ULN in patients with liver metastases)
Serum albumin level ≥3.0g/dL
Serum AKP < 2.5 times ULN
Serum creatinine <ULN, and CCr < 60ml/min
Bilirubin level < 1.5 ULN
WBC>3,000/mm3, absolute neutrophil count ≥2000/mm3, platelet>100,000/mm3, Hb>9g/dl

Exclusion Criteria:

Brain metastasis (known or suspected)
Previous systemic therapy for metastatic gastric cancer
Inability to take oral medication
Previous therapy targeting at angiogenesis or vasculogenesis pathway or other targeted therapy
Surgery (excluding diagnostic biopsy) within 4 weeks prior to study entry
Contraindications of nuclear magnetic resonance image such as fitment of cardiac pacemaker , nerve stimulator, or aneurysm clip, and metallic foreign body in eye ball and so on.
Allergic constitution or allergic history to protium biologic product or any investigating agents.
Severe heart disease or such history as recorded congestive heart failure, uncontrolled cardiac arrhythmia, angina pectoris needing medication, cardiac valve disease, severe abnormal ECG findings, cardiac infarction , or retractable hypertension.
Pregnancy or lactation period
Any investigational agent within the past 28 days
Other previous malignancy within 5 year, except non-melanoma skin cancer
Previous adjuvant therapy with capecitabine+platinum,
Pre-existing neuropathy>grade 1
Legal incapacity
No Results Posted