FOLFIRI as Second Line Chemotherapy for Metastatic Esophageal Carcinoma

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

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

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.

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