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

NCT00842491 | Completed Phase 2 DMC

• 1 other identifier: ENDOCX
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  3 year

Secondary Outcomes (5)

• Tumor response rate

  1 year

• Disease control rate

  1 year

• Overall survival

  5 year

• adverse evens

  5 year

• The alteration of relative regional blood volume of the tumor

  3weeks

Study Arms (1)

endostar+chemotherapy

EXPERIMENTAL

Drug: endostar, cisplatin, capecitabine; Drug: capecitabine; Drug: cisplatin

Interventions

endostar, cisplatin, capecitabine DRUG

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

endostar+chemotherapy

capecitabine DRUG

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

endostar+chemotherapy

cisplatin DRUG

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

endostar+chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University: lead
• Xiansheng Pharmaceutical Company: collaborator

Study Sites (1)

Department of GI Oncology, Peking University, School of Oncology

Beijing, Beijing Municipality, 100142, China

Location

MeSH Terms

Interventions

endostar protein; Cisplatin; Capecitabine

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• lin shen, MD

  Peking University, School of oncology, Department of GI oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: pro.

Study Record Dates

• First Submitted: February 11, 2009
• First Posted: February 12, 2009
• Study Start: November 1, 2008
• Primary Completion: April 1, 2010
• Study Completion: December 1, 2010
• Last Updated: May 19, 2015

Record last verified: 2015-05

Locations

CN (1)