Status:
UNKNOWN
Afatinib Plus Chemotherapy Against Esophageal or Lung Squamous Cell Carcinoma
Lead Sponsor:
Fujian Cancer Hospital
Conditions:
Squamous Cell Carcinoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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 stud...
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 disea...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2020
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT03486509
Start Date
April 1 2018
End Date
July 1 2020
Last Update
April 3 2018
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