Study of Icotinib Hydrochloride in Treating Patients With Recurrent or Metastatic Esophageal Cancer After Failure of Conventional Chemotherapy
Conditions
Esophageal Squamous Cell Carcinoma
Conditions: official terms
Carcinoma, Squamous Cell - Esophageal Neoplasms
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Icotinib Hydrochloride
Type: Drug
Overall Status
Recruiting
Summary
This phase Ⅱ study was designed to evaluate the efficacy and safety of Icotinib Hydrochloride as treatment for patients with recurrent or metastasis esophageal squamous carcinoma after failure of conventional chemotherapy. Prospective evaluation of biomarkers is also performed in searching for appropriate predictive molecular markers of benefit people treated with Icotinib Hydrochloride as second-line theory in esophageal squamous carcinoma.
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
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
Location
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Status: Recruiting
Contact: Li Yuhong, MD - liyh@sysucc.org.cn
Start Date
October 2013
Completion Date
December 2015
Sponsors
Yuhong Li
Source
Sun Yat-sen University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page