Clinical trial NCT01973725: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Esophageal Squamous Cell Carcinoma
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2013-10-31
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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

Primary outcomes:
measure: Disease control rate
timeFrame: for up to 6 months
Secondary outcomes:
measure: Overall survival
timeFrame: Time from day 1 to date of death
measure: Time to progression
timeFrame: Time from day 1 to date of documented disease progression
measure: Adverse event
timeFrame: Each follow up vist, assessed up to 12 months
measure: EORTC QLQ-C30 and QLQ-OES18
timeFrame: Time from day 1 to date of death
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Li Yuhong, MD
role: PRINCIPAL_INVESTIGATOR
References: