FOLFIRI as Second Line Chemotherapy for Metastatic Esophageal Carcinoma

Study Overview
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Brief Summary
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This phase Ⅱ study was designed to evaluate the efficacy and safety of FOLFIRI as second-line treatment for metastatic esophageal carcinoma.

Detailed Description
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Although there are no standard second-line treatment for metastatic esophageal carcinoma, some studies have showed that irinotecan, fluorouracil may be effective in treating patients with metastatic esophageal carcinoma after failure of first-line treatment. Since irinotecan, fluorouracil, and leucovorin work in different ways to stop the growth of tumor. Giving more than one drug may be more effective. In this phase Ⅱ trial, the investigator would like to observe the efficacy and safety of FOLFIRI(Irinotecan/5-FU/leucovorin ) as second-line treatment for metastatic esophageal carcinoma.

Official Title
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Phase Ⅱ Study of FOLFIRI as Second-Line Chemotherapy for Metastatic Esophageal Carcinoma

Conditions
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Advanced Esophageal Carcinoma

Intervention / Treatment
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* Drug: FOLFIRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients have provided a signed Informed Consent Form Karnofsky score ≥70 Age: 18-75 years old Histologically confirmed diagnosis of advanced esophageal carcinoma Patients have Received and progressed on first-line treatment, and not received CPT-11 or Fluoropyrimidine based palliative chemotherapy Measurable disease in at least 1 diameter by CT scan or MRI as per RECIST 1.1 criteria Life expectancy ≥ 3 months Patient has adequate bone marrow and organ function Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L Platelets ≥ 75 x 109/L Hemoglobin ≥ 9.0 g/dL Patient has adequate liver function AST and ALT not more than 2.5 times ULN (not more than 5.0 times ULN if there is liver metastasis) Serum bilirubin ≤ 2 x ULN Creatinine ≤ 1.5 times ULN Good compliance Exclusion Criteria: Pregnant or lactating women Brain metastasis or only with bone metastasis. Patients with severe infection or active peptic ulcer which need treatment Severe systemic disease out of control such as unstable or uncompensated respiratory, cardiac, liver, renal diseases Patient has a concurrent malignancy or has a malignancy within 5 years of study enrollment, (with the exception of non-melanoma skin cancer or cervical carcinoma in situ Psychiatric illness that would prevent the patient from giving informed consent Patient is concurrently using other approved or investigational antineoplastic agent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FOLFIRI<br>Patients will receive FOLFIRI every 2 weeks: Irinotecan 180mg/m2 IV over 90 minutes on Day 1; Leucovorin IV over 2 hours on Day 1(l-LV 200 mg/m2 or dl-LV 400 mg/m2 ); 5-Fluorouracil 400 mg/m2 IV bolus on Day 1; followed by 5-Fluorouracil 2.4 g/m2 for 46 hours continuous infusion. | Drug: FOLFIRI<br>* Patients will receive FOLFIRI every 2 weeks: Irinotecan 180mg/m2 IV over 90 minutes on Day 1; Leucovorin IV over 2 hours on Day 1(l-LV 200 mg/m2 or dl-LV 400 mg/m2 ); 5-Fluorouracil 400 mg/m2 IV bolus on Day 1; followed by 5-Fluorouracil 2.4 g/m2 for 46 hours continuous infusion.<br>* Other names: 5-Fluorouracil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease control rate |  | Up to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | From the date of first drug administration until the date of death, assessed up to 60months | 
| Adverse events | Safety profile will be assessed using the NCI CTCAE version 3.0 | Each follow up visit, assessed up to 24 weeks | 
| Progression free survival |  | From the date of first drug administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months |