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

Advanced Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00842491
• Other study ID #: ENDOCX
• Status: Completed
• Phase: Phase 2
• First received: February 11, 2009
• Last updated: May 17, 2015
• Start date: November 2008
• Est. completion date: December 2010

Study information

• Verified date: May 2015
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Advanced Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• endostar, cisplatin, capecitabine
Product 1: endostar Dosing schedule: 15mg daily dose, d1-14 Mode of administration: intravenously
• capecitabine
Product 2: capecitabine Dosing schedule: 1000mg/m2 bid, days 1-14, every 3 weeks Mode of administration: orally
• cisplatin
Product 3: cisplatin Dosing schedule: 80mg/m2, day 1 of every 3 weeks Mode of administration: intravenously

Locations

Country	Name	City	State
China	Department of GI Oncology, Peking University, School of Oncology	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking University	Xiansheng Pharmaceutical Company

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival		3 year	No
Secondary	Tumor response rate		1 year	No
Secondary	Disease control rate		1 year	No
Secondary	Overall survival		5 year	No
Secondary	adverse evens		5 year	Yes
Secondary	The alteration of relative regional blood volume of the tumor		3weeks	No