- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01486992
mFOLFIRI Combine With Nimotuzumab Second Line Chemotherapy for Squamous-cell Carcinoma of the Esophagus
January 11, 2012 updated by: Shen Lin, Peking University
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100142
- Recruiting
- Zhang Xiaodong
-
Contact:
- XIAODONG ZHANG, MD
- Phone Number: 861088196175
- Email: zxd0829@yahoo.com.cn
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
overall survival
Time Frame: 2 years
|
2 years
|
adverse events
Time Frame: 2 weeks
|
2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
progression-free survival
Time Frame: 1year
|
1year
|
disease control rate
Time Frame: 6 weeks
|
6 weeks
|
response rate
Time Frame: 6 weeks
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2011
Primary Completion (Anticipated)
November 1, 2012
Study Completion (Anticipated)
November 1, 2012
Study Registration Dates
First Submitted
November 22, 2011
First Submitted That Met QC Criteria
December 5, 2011
First Posted (Estimate)
December 7, 2011
Study Record Updates
Last Update Posted (Estimate)
January 12, 2012
Last Update Submitted That Met QC Criteria
January 11, 2012
Last Verified
November 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Head and Neck Neoplasms
- Esophageal Diseases
- Carcinoma
- Esophageal Neoplasms
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Nimotuzumab
Other Study ID Numbers
- N+FOLFIRI-AEC-4
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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