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FOLFIRI as Second Line Chemotherapy for Metastatic Esophageal Carcinoma

Primary Purpose

Advanced Esophageal Carcinoma

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
FOLFIRI
Sponsored by
Yuhong Li
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Esophageal Carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sun Yat-sen University Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FOLFIRI

Arm Description

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.

Outcomes

Primary Outcome Measures

Disease control rate

Secondary Outcome Measures

Overall survival
Adverse events
Safety profile will be assessed using the NCI CTCAE version 3.0
Progression free survival

Full Information

First Posted
December 16, 2013
Last Updated
February 14, 2023
Sponsor
Yuhong Li
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1. Study Identification

Unique Protocol Identification Number
NCT02023593
Brief Title
FOLFIRI as Second Line Chemotherapy for Metastatic Esophageal Carcinoma
Official Title
Phase Ⅱ Study of FOLFIRI as Second-Line Chemotherapy for Metastatic Esophageal Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
March 2012 (Actual)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
December 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yuhong Li

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Esophageal Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FOLFIRI
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
FOLFIRI
Other Intervention Name(s)
Irinotecan, Leucovorin, 5-Fluorouracil
Intervention Description
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.
Primary Outcome Measure Information:
Title
Disease control rate
Time Frame
Up to 24 weeks
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
From the date of first drug administration until the date of death, assessed up to 60months
Title
Adverse events
Description
Safety profile will be assessed using the NCI CTCAE version 3.0
Time Frame
Each follow up visit, assessed up to 24 weeks
Title
Progression free survival
Time Frame
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Yuhong, Ph D
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China

12. IPD Sharing Statement

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FOLFIRI as Second Line Chemotherapy for Metastatic Esophageal Carcinoma

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