Clinical Trials /

Study of Icotinib Hydrochloride in Treating Patients With Recurrent or Metastatic Esophageal Cancer After Failure of Conventional Chemotherapy

NCT01973725

Description:

Phase II Study of Icotinib Hydrochloride in Treating Patients With Recurrent or Metastatic Esophageal Squamous Carcinoma After Failure of Conventional Chemotherapy.

Related Conditions:
  • Esophageal Squamous Cell Carcinoma
Recruiting Status:

Unknown status

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Study of Icotinib Hydrochloride in Treating Patients With Recurrent or Metastatic Esophageal Cancer After Failure of Conventional Chemotherapy
  • Official Title: PhaseⅡ Study of Icotinib Hydrochloride in Treating Patients With Recurrent or Metastatic Esophageal Squamous Carcinoma After Failure of Conventional Chemotherapy

Clinical Trial IDs

  • ORG STUDY ID: ICO-29
  • NCT ID: NCT01973725

Conditions

  • Esophageal Squamous Cell Carcinoma

Interventions

DrugSynonymsArms
Icotinib HydrochlorideConmanaIcotinib Hydrochloride

Purpose

Phase II Study of Icotinib Hydrochloride in Treating Patients With Recurrent or Metastatic Esophageal Squamous Carcinoma After Failure of Conventional Chemotherapy.

Detailed Description

      Currently,there is no standard second-line therapy for esophageal squamous cell
      carcinoma.More effective therapy for patients with this disease who developed disease
      progression after first line therapy is needed.Although Erlotinib is recommended in NCCN
      Guideline Version 2.2013,there is still insufficient evidence on EGFR-TKI as second-line
      therapy for esophageal squamous carcinoma.Therefore,further research is necessary.In this
      phase II study,we evaluate the efficacy and safety of Icotinib Hydrochloride as treatment for
      patients with recurrent or metastasis esophageal squamous carcinoma after failure of
      conventional chemotherapy,and analyse the value of biomarkers of these patient to identify
      who benefit.
    

Trial Arms

NameTypeDescriptionInterventions
Icotinib HydrochlorideExperimentalPatients will receive Icotinib Hydrochloride at 125mg/times,oral three times daily for 21 days.
  • Icotinib Hydrochloride

Eligibility Criteria

        Inclusion Criteria:

          -  Patients have provided a signed Informed Consent Form

          -  Age: 18-75 years old

          -  Histologically confirmed diagnosis of esophageal squamous cell carcinoma

          -  Patients have Received and progressed on 1 line of prior Fluoropyrimidine, platinum or
             taxane 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

          -  Karnofsky score ≥70

          -  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

          -  No malabsorption or other gastrointestinal disorders affecting drug absorption.

          -  No serious complications such as active gastrointestinal hemorrhage, perforation,
             jaundice, gastrointestinal obstruction, non cancerous fever > 38 ℃.

          -  Expect good compliance

        Exclusion Criteria:

          -  Patient has received previous treatment with EGFR inhibitors

          -  Patient is currently receiving Phenytoin, rifampin, barbiturates, C Masi Bing

          -  Known severe hypersensitivity to Icotinib or any of the excipients of this product

          -  CNS metastases without radiotherapy and/or surgery

          -  Patients with treated CNS metastases may participate in this trial,except for those
             who must receive hormone therapy and those whose prior hormone therapy for CNS
             metastases is less than 4 weeks

          -  Evidence of clinically active Interstitial Lung Diseases

          -  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 nonmelanoma 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

          -  Pregnant or lactating women
      
Maximum Eligible Age:75 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Disease control rate
Time Frame:6 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Overall survival
Time Frame:Time from day 1 to date of death
Safety Issue:
Description:
Measure:Time to progression
Time Frame:Time from day 1 to date of documented disease progression
Safety Issue:
Description:
Measure:Safety
Time Frame:Each follow up vist, assessed up to 12 months
Safety Issue:
Description:Safety data will be assessed at each study visit using NCI CTCAE version 3.0
Measure:Quality of life
Time Frame:Time from day 1 to date of death
Safety Issue:
Description:Quality of life will be assessed at each study visit using EORTC QLQ-C30 and QLQ-OES18

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Yuhong Li

Last Updated

January 31, 2018