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

Primary Purpose

Advanced Esophageal Carcinoma

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
mFOLFIRI+Nimotuzumab
Sponsored by
Peking University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Esophageal Carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Zhang XiaodongRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nimotuzumab

Arm Description

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

Outcomes

Primary Outcome Measures

overall survival
adverse events

Secondary Outcome Measures

progression-free survival
response rate
disease control rate

Full Information

First Posted
November 22, 2011
Last Updated
January 11, 2012
Sponsor
Peking University
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1. Study Identification

Unique Protocol Identification Number
NCT01486992
Brief Title
mFOLFIRI Combine With Nimotuzumab Second Line Chemotherapy for Squamous-cell Carcinoma of the Esophagus
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Unknown status
Study Start Date
November 2011 (undefined)
Primary Completion Date
November 2012 (Anticipated)
Study Completion Date
November 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Esophageal Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nimotuzumab
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
mFOLFIRI+Nimotuzumab
Intervention Description
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
Primary Outcome Measure Information:
Title
overall survival
Time Frame
2 years
Title
adverse events
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
progression-free survival
Time Frame
1year
Title
response rate
Time Frame
6 weeks
Title
disease control rate
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
xiaodong zhang, MD
Phone
861088196175
Email
zxd0829@yahoo.com.cn
Facility Information:
Facility Name
Zhang Xiaodong
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
XIAODONG ZHANG, MD
Phone
861088196175
Email
zxd0829@yahoo.com.cn

12. IPD Sharing Statement

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

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