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

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ClinicalTrials.gov Identifier: NCT01973725
Recruitment Status : Recruiting
First Posted : October 31, 2013
Last Update Posted : February 2, 2018
Sponsor:
Information provided by (Responsible Party):
Yuhong Li, Sun Yat-sen University

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

Condition or disease Intervention/treatment Phase
Esophageal Squamous Cell Carcinoma Drug: Icotinib Hydrochloride Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PhaseⅡ Study of Icotinib Hydrochloride in Treating Patients With Recurrent or Metastatic Esophageal Squamous Carcinoma After Failure of Conventional Chemotherapy
Study Start Date : October 2013
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Icotinib Hydrochloride
Patients will receive Icotinib Hydrochloride at 125mg/times,oral three times daily for 21 days.
Drug: Icotinib Hydrochloride
Patients will receive Icotinib Hydrochloride at 125mg/times,oral three times daily for 21 days.
Other Name: Conmana




Primary Outcome Measures :
  1. Disease control rate [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: Time from day 1 to date of death ]
  2. Time to progression [ Time Frame: Time from day 1 to date of documented disease progression ]
  3. Safety [ Time Frame: Each follow up vist, assessed up to 12 months ]
    Safety data will be assessed at each study visit using NCI CTCAE version 3.0

  4. Quality of life [ Time Frame: Time from day 1 to date of death ]
    Quality of life will be assessed at each study visit using EORTC QLQ-C30 and QLQ-OES18



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01973725


Contacts
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Contact: Li Yuhong, MD liyh@sysucc.org.cn

Locations
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China, Guangdong
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Li Yuhong, MD       liyh@sysucc.org.cn   
Principal Investigator: Li Yuhong, MD         
Sponsors and Collaborators
Yuhong Li
Investigators
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Principal Investigator: Li Yuhong, MD Sun Yat-sen University

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Responsible Party: Yuhong Li, MD, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01973725     History of Changes
Other Study ID Numbers: ICO-29
First Posted: October 31, 2013    Key Record Dates
Last Update Posted: February 2, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases