FOLFIRI as Second Line Chemotherapy for Metastatic Esophageal Carcinoma

NCT02023593 | Completed Phase 2 DMC

• 1 other identifier: FOLFIRI-29
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Advanced Esophageal Carcinoma

Outcome Measures

Primary Outcomes (1)

• Disease control rate

  Up to 24 weeks

Secondary Outcomes (3)

• Overall survival

  From the date of first drug administration until the date of death, assessed up to 60months

• Adverse events

  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

Study Arms (1)

FOLFIRI

EXPERIMENTAL

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

Interventions

FOLFIRI DRUG

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.

Also known as: Irinotecan, Leucovorin, 5-Fluorouracil

FOLFIRI

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yuhong Li: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Interventions

IFL protocol; Irinotecan; Leucovorin; Fluorouracil

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Li Yuhong, Ph D

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD,Ph D

Study Record Dates

• First Submitted: December 16, 2013
• First Posted: December 30, 2013
• Study Start: March 1, 2012
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2022
• Last Updated: February 16, 2023

Record last verified: 2023-02

Locations

CN (1)