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Afatinib Plus Chemotherapy Against Esophageal or Lung Squamous Cell Carcinoma

Primary Purpose

Squamous Cell Carcinoma

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Afatinib
Sponsored by
Fujian Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Squamous Cell Carcinoma focused on measuring afatinib

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients must understand the rigors of the study and provide written informed consent and HIPAA authorization prior to initiation of any study procedures
  • Life expectancy > 10 months
  • Karnofsky Performance Status ≥ 70
  • Diagnosis of histological or cytologically confirmed squamous lung cancer or esophageal squamous cancer,
  • Age ≥ 18 years
  • Adequate organ and bone marrow function, defined as: Bone marrow: absolute neutrophil count (ANC) ≥ 1.5 x 109/L; hemoglobin > 9 g/dL; platelets > 100 x 109/L Renal: creatinine clearance ≥ 50 mL/min (calculated according to Cockroft and Gault) or creatinine ≤ 1.5 mg/dL Hepatic: bilirubin ≤ 1.5 x the upper limit of normal (ULN); aspartate transaminases (AST/SGOT) and alanine transaminases (ALT/SGPT) ≤ 2.5 x ULN (or ≤ 5 x ULN if due to underlying liver metastases); internation normalized value for prothrombin time (INR) ≤ 1.5 x ULN (except in the case of anticoagulation therapy), albumin ≥ 2.0
  • Good medical candidate for and willing to undergo a biopsy or surgical procedure to obtain tissue, which may or may not be part of the patient's routine care for their malignancy.

Exclusion Criteria:

  • Poor compliance, reluctant to undergo research medication, or follow-up.
  • Tumor inaccessible for biopsy
  • It is currently included in clinical trials of other drugs, or at the same time, into other medical studies that are considered incompatible with the study.
  • It has a history of other cancers, unless the cancer is completely relieved and has not been treated for more than 3 years.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    afatinib 40mg bid plus chemotherapy

    Arm Description

    afatinib 40mg bid po plus chemotherapy

    Outcomes

    Primary Outcome Measures

    PFS
    Progression-Free-Survival

    Secondary Outcome Measures

    ORR
    objective response rate

    Full Information

    First Posted
    December 18, 2017
    Last Updated
    March 31, 2018
    Sponsor
    Fujian Cancer Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03486509
    Brief Title
    Afatinib Plus Chemotherapy Against Esophageal or Lung Squamous Cell Carcinoma
    Official Title
    Phase II Study of Afatinib Plus Chemotherapy in Patients With Esophageal and Lung Squamous Cell Carcinoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 1, 2018 (Anticipated)
    Primary Completion Date
    March 1, 2020 (Anticipated)
    Study Completion Date
    July 1, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Fujian Cancer Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    As a 2nd generation EGFR-TKI that irreversibly binds to EGFR receptors, afatinib is currently recommended as the standard first-line treatment for EGFR mutation-positive lung cancer, and clinical studies are also being actively conducted in other types of carcinomas characterized by EGFR gene mutation and overexpression. The overall results from previous studies of gefitinib and erlotinib as EGFR TKIs , as well as from preceding studies of afatinib - a 2nd generation EGFR TKI - suggest the possibility of an effective therapy in esophageal cancer or squmaous lung cancer. In this phase II trial, afatinib shall be administered to patients with squamous cell carcinoma of esophagus or lung squamous cell carcinoma to evaluate its effects and toxicity. Also, biomarkers to predict responses to afatinib shall be explored through further studies.
    Detailed Description
    As a 2nd generation EGFR-TKI that irreversibly binds to EGFR receptors, In a phase III study LUX-lung 8 in patients with squamous lung cancer, afatinib monotherapy showed longer progression-free disease survival than erlotinib therapy. afatinib is currently recommended as the standard first-line treatment for EGFR mutation-positive lung cancer, and clinical studies are also being actively conducted in other types of carcinomas characterized by EGFR gene mutation and overexpression. Thirty (30) solid cancer patients were included in a phase I trial of afatinib, and of them, a patient with esophageal cancer had partial response. Taken together, based upon the results from clinical trials of afatinib conducted so far, 7 out of 15 esophageal cancer patients achieved clinical responses of 3 months or longer. Hence, the overall results from previous studies of gefitinib and erlotinib as EGFR TKIs and our study of dacomitinib, as well as from preceding studies of afatinib - a 2nd generation EGFR TKI - suggest the possibility of an effective therapy in esophageal cancer or squmaous lung cancer. In this phase II trial, afatinib shall be administered to patients with squamous cell carcinoma of esophagus or lung squamous cell carcinoma to evaluate its effects and toxicity. Also, biomarkers to predict responses to afatinib shall be explored through further studies.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Squamous Cell Carcinoma
    Keywords
    afatinib

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    2 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    afatinib 40mg bid plus chemotherapy
    Arm Type
    Experimental
    Arm Description
    afatinib 40mg bid po plus chemotherapy
    Intervention Type
    Drug
    Intervention Name(s)
    Afatinib
    Intervention Description
    afatinb 40mg po bid
    Primary Outcome Measure Information:
    Title
    PFS
    Description
    Progression-Free-Survival
    Time Frame
    through study completion, an average of 2 year
    Secondary Outcome Measure Information:
    Title
    ORR
    Description
    objective response rate
    Time Frame
    through study completion, an average of 2 year
    Other Pre-specified Outcome Measures:
    Title
    adverse events
    Description
    the Common Terminology Criteria for Adverse Events ver. 4.0
    Time Frame
    through study completion, an average of 2 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients must understand the rigors of the study and provide written informed consent and HIPAA authorization prior to initiation of any study procedures Life expectancy > 10 months Karnofsky Performance Status ≥ 70 Diagnosis of histological or cytologically confirmed squamous lung cancer or esophageal squamous cancer, Age ≥ 18 years Adequate organ and bone marrow function, defined as: Bone marrow: absolute neutrophil count (ANC) ≥ 1.5 x 109/L; hemoglobin > 9 g/dL; platelets > 100 x 109/L Renal: creatinine clearance ≥ 50 mL/min (calculated according to Cockroft and Gault) or creatinine ≤ 1.5 mg/dL Hepatic: bilirubin ≤ 1.5 x the upper limit of normal (ULN); aspartate transaminases (AST/SGOT) and alanine transaminases (ALT/SGPT) ≤ 2.5 x ULN (or ≤ 5 x ULN if due to underlying liver metastases); internation normalized value for prothrombin time (INR) ≤ 1.5 x ULN (except in the case of anticoagulation therapy), albumin ≥ 2.0 Good medical candidate for and willing to undergo a biopsy or surgical procedure to obtain tissue, which may or may not be part of the patient's routine care for their malignancy. Exclusion Criteria: Poor compliance, reluctant to undergo research medication, or follow-up. Tumor inaccessible for biopsy It is currently included in clinical trials of other drugs, or at the same time, into other medical studies that are considered incompatible with the study. It has a history of other cancers, unless the cancer is completely relieved and has not been treated for more than 3 years.

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Afatinib Plus Chemotherapy Against Esophageal or Lung Squamous Cell Carcinoma

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