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

Sponsor

Peking University (Other)

Overall Status

Unknown status

CT.gov ID

NCT01486992

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Advanced Esophageal Carcinoma	Drug: mFOLFIRI+Nimotuzumab	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Study Start Date :

Nov 1, 2011

Anticipated Primary Completion Date :

Nov 1, 2012

Anticipated Study Completion Date :

Nov 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	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

Arm

Intervention/Treatment

Experimental: 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

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

Outcome Measures

Primary Outcome Measures

overall survival [2 years]
adverse events [2 weeks]

Secondary Outcome Measures

progression-free survival [1year]
response rate [6 weeks]
disease control rate [6 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhang Xiaodong	Beijing	Beijing	China	100142

Sponsors and Collaborators

Peking University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shen Lin, HEAD OF GI ONCOLOGY, Peking University

ClinicalTrials.gov Identifier:

NCT01486992

Other Study ID Numbers:

N+FOLFIRI-AEC-4

First Posted:

Dec 7, 2011

Last Update Posted:

Jan 12, 2012

Last Verified:

Nov 1, 2011

Additional relevant MeSH terms:

Carcinoma

Esophageal Neoplasms

Nimotuzumab

Study Results

No Results Posted as of Jan 12, 2012