Afatinib Plus Chemotherapy Against Esophageal or Lung Squamous Cell Carcinoma

NCT03486509 | Unknown Phase 2

• 1 other identifier: CSWOG201702
• Study Type: interventional
• Target: 2
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Squamous Cell Carcinoma

Keywords

afatinib

Outcome Measures

Primary Outcomes (1)

• PFS

  Progression-Free-Survival

  through study completion, an average of 2 year

Secondary Outcomes (1)

• ORR

  through study completion, an average of 2 year

Other Outcomes (1)

• adverse events

  through study completion, an average of 2 year

Study Arms (1)

afatinib 40mg bid plus chemotherapy

EXPERIMENTAL

afatinib 40mg bid po plus chemotherapy

Drug: Afatinib

Interventions

Afatinib DRUG

afatinb 40mg po bid

afatinib 40mg bid plus chemotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fujian Cancer Hospital: lead

MeSH Terms

Conditions

Carcinoma, Squamous Cell

Interventions

Afatinib

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2017
• First Posted: April 3, 2018
• Study Start: April 1, 2018
• Primary Completion: March 1, 2020
• Study Completion: July 1, 2020
• Last Updated: April 3, 2018

Record last verified: 2017-12