mFOLFIRI Combine With Nimotuzumab Second Line Chemotherapy for Squamous-cell Carcinoma of the Esophagus

Advanced Esophageal Carcinoma Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01486992
• Other study ID #: N+FOLFIRI-AEC-4
• Status: Recruiting
• Phase: Phase 2
• First received: November 22, 2011
• Last updated: January 11, 2012
• Start date: November 2011
• Est. completion date: November 2012

Study information

• Verified date: November 2011
• Source: Peking University
• Contact: xiaodong zhang, MD
• Phone: 861088196175
• Email: zxd0829[@]yahoo.com.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

There are few studies about 2nd line treatment in advanced esophageal carcinoma (AEC), some showed that irinotecan may be effective. The investigators previous study has shown the efficacy and safety of paclitaxel/cisplatin as 1st line treatment, so in this phase II study, the investigators would like to observe the efficacy and safety of Nimotuzumab plus Irinotecan/5FU/leucovorin as 2nd line treatment if AEC after failure to 1st treatment of PTX/DDP.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Histologically confirmed esophageal squamous carcinoma,failed to 1st line treatment of paclitaxel/cisplatin

• Age 18 to 75 years old

• Measurable disease according to the RECIST criteria(diameter of the lesion should be more than 10mm by spiral CT or MRI, more than 20mm by common CT, the date of image should be less than 15 days before enrollment)

• Life expectancy of =3 month

• Karnofsky performance status =80

• WBC>3,500/mm3, absolute neutrophil count =2000/mm3, platelet>100,000/mm3, Hb>9g/dl,Bilirubin level < 1.0 times ULN,Serum creatinine <1.0 times ULN,ALT and AST<2.5 times ULN ,AKP < 2.5 times ULN ,(=5 times ULN in patients with liver metastases)(within 7 days before enrollment)

• No sever complication, such as active gastrointestinal bleeding, perforation, jaundice, obstruction, non-cancerous fever>38?;

• Normal ECG/cardiac function

• Good compliance

• Having signed informed consent

Exclusion Criteria:

• More than 1 Previous systemic therapy for metastatic esophageal squamous carcinoma

• Known hypersensitivity to study drugs

• Tumor with length=10cm, liver metastasis covers more than 50% of liver,or lung metastasis covers more than 25% of lung

• No measurable lesions, eg. pleural fluid and ascites

• Only with Other previous malignancy within 5 year, except non-melanoma skin cancer

• Heart failure or other sever organ dysfunction, eg. coronary artery disease, myocardial infarction within the last 6 months only Brain or bone metastasis

• Chronic diarrhea

• Mentally abnormal or disable cognition,including CNS metastasis

• Pregnancy or lactation period

Study Design

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

Related Conditions & MeSH terms

• Advanced Esophageal Carcinoma
• Esophageal Neoplasms

Intervention

Drug:
• mFOLFIRI+Nimotuzumab
irinotecan 180mg/m2,iv ,d1,LV 200 mg/m2 ,2h,d1,5-FU 400 mg/m2, iv,d1 5-FU 2400mg/m2,CIV,46h,q2w Nimotuzumab 200mg,iv,qw

Locations

Country	Name	City	State
China	Zhang Xiaodong	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival		2 years	No
Primary	adverse events		2 weeks	Yes
Secondary	progression-free survival		1year	No
Secondary	response rate		6 weeks	No
Secondary	disease control rate		6 weeks	No