mFOLFIRI as the Second Line Chemotherapy for Advanced Esophageal Carcinoma After Failure of 1st Line Treatment of Paclitaxel/DDP : a Phase II Single Center Prospective Clinical Trial

Study Overview
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Brief Summary
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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 Irinotecan/5FU/leucovorin as 2nd line treatment if AEC after failure to 1st treatment of PTX/DDP.

Conditions
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Advanced Esophageal Carcinoma

Intervention / Treatment
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* Drug: mFOLFIRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Having signed informed consent Age 18 to 70 years old Histologically confirmed esophageal squamous carcinoma,failed to 1st line treatment of paclitaxel/cisplatin Unresectable recurrent or metastatic disease 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) Karnofsky performance status ≥70 Life expectancy of ≥3 month No prior radiotherapy except radiotherapy at non-target lesion of the study more than 4 weeks ALT and AST<2.5 times ULN (≤5 times ULN in patients with liver metastases)(within 7 days before enrollment) Serum AKP < 2.5 times ULN (within 7 days before enrollment) Serum creatinine <1.0 times ULN (within 7 days before enrollment) Bilirubin level < 1.0 times ULN (within 7 days before enrollment) WBC>4,000/mm3, absolute neutrophil count ≥2000/mm3, platelet>100,000/mm3, Hb>9g/dl(within 7 days before enrollment) No sever complication, such as active gastrointestinal bleeding, perforation, jaundice, obstruction, non-cancerous fever>38℃； Good compliance Exclusion Criteria: More than 1 Previous systemic therapy for metastatic esophageal squamous carcinoma Known hypersensitivity to irinotecan Only with Brain or bone metastasis 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 Surgery (excluding diagnostic biopsy) within 4 weeks prior to study entry Heart failure or other sever organ dysfunction, eg. coronary artery disease, myocardial infarction within the last 6 months or Pregnancy or lactation period Other previous malignancy within 5 year, except non-melanoma skin cancer Chronic diarrhea Mentally abnormal or disable cognition,including CNS metastasis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mFOLFIRI<br> | Drug: mFOLFIRI<br>* mFOLFIRI irinotecan 130-150mg/m2 iv d1 LV 200 mg/m2 iv 2h d1 5-FU 400 mg/m2 IV d1 5-FU 2.4-3 g/m2 CI 46-h repeat every 2 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 2 year | 
| adverse events |  | after each cycle of chemotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival |  | 1year | 
| response rate |  | every 6 weeks |