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

Esophageal Squamous Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01973725
• Other study ID #: ICO-29
• Status: Completed
• Phase: Phase 2
• Start date: October 2013
• Est. completion date: December 2018

Study information

• Verified date: February 2023
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Esophageal Squamous Cell Carcinoma

Intervention

Drug:
• Icotinib Hydrochloride
Patients will receive Icotinib Hydrochloride at 125mg/times,oral three times daily for 21 days.

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Yuhong Li

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease control rate	Disease control rate of tumor	for up to 6 months
Secondary	Overall survival	From time of diagnosis to death or lost to follow-up	Time from day 1 to date of death
Secondary	Time to progression	From time of diagnosis to disease progression	Time from day 1 to date of documented disease progression
Secondary	Adverse event	Safety data will be assessed at each study visit using NCI CTCAE version 3.0	Each follow up vist, assessed up to 12 months
Secondary	EORTC QLQ-C30 and QLQ-OES18	Quality of life will be assessed at each study visit using EORTC QLQ-C30 and QLQ-OES18	Time from day 1 to date of death