Study of Endostar With Cisplatin and Capecitabine as 1st Line Treatment in the Advanced Gastric Cancer

NCT ID: NCT00842491

Last Updated: 2015-05-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2010-12-31

Brief Summary

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.

Detailed Description

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.

Conditions

Advanced Gastric Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

endostar+chemotherapy

Group Type: EXPERIMENTAL

endostar, cisplatin, capecitabine

Intervention Type: DRUG

Product 1: endostar

Dosing schedule: 15mg daily dose, d1-14

Mode of administration: intravenously

capecitabine

Intervention Type: DRUG

Product 2: capecitabine

Dosing schedule: 1000mg/m2 bid, days 1-14, every 3 weeks

Mode of administration: orally

cisplatin

Intervention Type: DRUG

Product 3: cisplatin

Dosing schedule: 80mg/m2, day 1 of every 3 weeks

Mode of administration: intravenously

Interventions

endostar, cisplatin, capecitabine

Product 1: endostar

Dosing schedule: 15mg daily dose, d1-14

Mode of administration: intravenously

Intervention Type: DRUG

capecitabine

Product 2: capecitabine

Dosing schedule: 1000mg/m2 bid, days 1-14, every 3 weeks

Mode of administration: orally

Intervention Type: DRUG

cisplatin

Product 3: cisplatin

Dosing schedule: 80mg/m2, day 1 of every 3 weeks

Mode of administration: intravenously

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xiansheng Pharmaceutical Company

UNKNOWN

Sponsor Role: collaborator

Peking University

OTHER

Sponsor Role: lead

Responsible Party

Shen Lin

pro.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

lin shen, MD

Role: PRINCIPAL_INVESTIGATOR

Peking University, School of oncology, Department of GI oncology

Locations

Department of GI Oncology, Peking University, School of Oncology

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

ENDOCX

Identifier Type: -

Identifier Source: org_study_id