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.

Study Overview

• Status: Completed
• Conditions: Advanced Esophageal Carcinoma
• Intervention / Treatment: Drug: FOLFIRI

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Li Yuhong, Ph D; Email: liyh@sysucc.org.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Sun Yat-Sen University Cancer Center

Participation Criteria

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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FOLFIRI; 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; 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.; Other Names: Leucovorin; Irinotecan; 5-Fluorouracil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Disease control rate	Up to 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Yuhong Li
• Investigators: Principal Investigator: Li Yuhong, Ph D, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2012
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: December 16, 2013
• First Submitted That Met QC Criteria: December 23, 2013
• First Posted (Estimate): December 30, 2013

Study Record Updates

• Last Update Posted (Estimate): February 16, 2023
• Last Update Submitted That Met QC Criteria: February 14, 2023
• Last Verified: February 1, 2023

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; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Protective Agents; Topoisomerase Inhibitors; Micronutrients; Vitamins; Topoisomerase I Inhibitors; Antidotes; Vitamin B Complex; Fluorouracil; Leucovorin; Irinotecan
• Other Study ID Numbers: FOLFIRI-29