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

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ClinicalTrials.gov Identifier: NCT01486992
Recruitment Status : Unknown
Verified November 2011 by Shen Lin, Peking University.
Recruitment status was:  Recruiting
First Posted : December 7, 2011
Last Update Posted : January 12, 2012
Sponsor:
Information provided by (Responsible Party):

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  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : November 2011
Estimated Primary Completion Date : November 2012
Estimated Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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


Outcome Measures

Primary Outcome Measures :
  1. overall survival [ Time Frame: 2 years ]
  2. adverse events [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. progression-free survival [ Time Frame: 1year ]
  2. response rate [ Time Frame: 6 weeks ]
  3. disease control rate [ Time Frame: 6 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01486992


Contacts
Contact: xiaodong zhang, MD 861088196175 zxd0829@yahoo.com.cn

Locations
China, Beijing
Zhang Xiaodong Recruiting
Beijing, Beijing, China, 100142
Contact: XIAODONG ZHANG, MD    861088196175    zxd0829@yahoo.com.cn   
Sponsors and Collaborators
Peking University
More Information

Responsible Party: Shen Lin, HEAD OF GI ONCOLOGY, Peking University
ClinicalTrials.gov Identifier: NCT01486992     History of Changes
Other Study ID Numbers: N+FOLFIRI-AEC-4
First Posted: December 7, 2011    Key Record Dates
Last Update Posted: January 12, 2012
Last Verified: November 2011

Additional relevant MeSH terms:
Carcinoma
Esophageal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases