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FOLFIRI as Second Line Chemotherapy for Metastatic Esophageal Carcinoma

Sponsor
Yuhong Li (Other)
Overall Status
Recruiting
CT.gov ID
NCT02023593
Collaborator
(none)
35
Enrollment
1
Location
1
Arm
129
Duration (Months)
0.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
35 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase Ⅱ Study of FOLFIRI as Second-Line Chemotherapy for Metastatic Esophageal Carcinoma
Study Start Date :
Mar 1, 2012
Anticipated Primary Completion Date :
Dec 1, 2019
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

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:
  • Irinotecan
  • Leucovorin
  • 5-Fluorouracil

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Disease control rate [Up to 24 weeks]

    Secondary Outcome Measures

    1. Overall survival [From the date of first drug administration until the date of death, assessed up to 60months]

    2. Safety [Each follow up visit, assessed up to 24 weeks]

      Safety data will be assessed at each study visiting using NCI CTCAE version 3.0

    3. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sun Yat-sen University Cancer Center Guangzhou Guangdong China 510060

    Sponsors and Collaborators

    • Yuhong Li

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yuhong Li, MD,Ph D, Sun Yat-sen University
    ClinicalTrials.gov Identifier:
    NCT02023593
    Other Study ID Numbers:
    • FOLFIRI-29
    First Posted:
    Dec 30, 2013
    Last Update Posted:
    Oct 29, 2019
    Last Verified:
    Oct 1, 2019
    Additional relevant MeSH terms:
    Carcinoma
    Esophageal Neoplasms
    Leucovorin
    Fluorouracil
    Irinotecan

    Study Results

    No Results Posted as of Oct 29, 2019