Description:
Phase II Study of Icotinib Hydrochloride in Treating Patients With Recurrent or Metastatic
Esophageal Squamous Carcinoma After Failure of Conventional Chemotherapy.
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
Drug | Synonyms | Arms |
---|
Icotinib Hydrochloride | Conmana | Icotinib 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
Name | Type | Description | Interventions |
---|
Icotinib Hydrochloride | Experimental | Patients will receive Icotinib Hydrochloride at 125mg/times,oral three times daily for 21 days. | |
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: | Unknown status |
Lead Sponsor: | Yuhong Li |
Last Updated
February 5, 2018