Status:
COMPLETED
Pilot Trial of EGF Ointment for the Patients With EGFR-i Related Skin Side Effects
Lead Sponsor:
Dong-A University Hospital
Conditions:
Non-small Cell Lung Cancer
Pancreatic Cancer
Eligibility:
All Genders
20+ years
Phase:
PHASE2
PHASE3
Brief Summary
The efficacy of the epidermal growth factor receptor (EGFR) inhibitors have been demonstrated in patients with non-small cell lung cancer (NSCLC), pancreatic cancer (PC) and colorectal cancer (CRC). D...
Detailed Description
The current study includes patients diagnosed with advanced NSCLC or PC or CRC, with pathological confirmation. The inclusion criteria were NSCLC treated with erlotinib alone and PC treated with gemci...
Eligibility Criteria
Inclusion
- Age: older than 20
- Eastern Cooperative Oncology Group (ECOG) performance status 0 -2
- Histologically confirmed lung cancer, pancreatic cancer, or colon cancer
- Patients take EGFR inhibitor following the reason
- EGFR mutation (+) NSCLC - adenocarcinoma for 1st line treatment
- NSCLC - for ≥ 2nd line treatment
- Pancreatic cancer - adenocarcinoma for 1st line treatment with Gemcitabine
- Colon cancer - adenocarcinoma 1st line treatment with Irinotecan (FOLFIRI)
- Patients who have EGFR inhibitor related skin side effects (ERSE) Gr≥2 (NCICTC V4.0)
- A patient with the willingness to comply with the study protocol during the study period and capable of complying with it
- A patient who signed the informed consent prior to the participation of the study and who understands that he/she has a right to withdrawal from participation in the study at any time without any disadvantages
Exclusion
- A patient with previous active or passive immunotherapy
- A pregnant or lactating patient
- A patient of childbearing potential without being tested for pregnancy at baseline for positive. (A postmenopausal woman with the amenorrhea period of at least 12 months or longer is considered to have non-childbearing potential.)
- A patient with history of uncontrolled seizures, central nervous system disorder or psychiatric disorders that are considered clinically significant by the investigator that would prohibit the understanding of informed consent or that may be considered to interfere with the compliance of the administration of the study medications
- A patient with history of dermatologic care (except transient urticaria) within 4 weeks
- A patient with clinically significant (i.e. active) heart disease (e.g. congestive heart failure, symptomatic coronary artery diseases, cardiac arrhythmias, etc) or myocardial infarction within past 12 months
- A patient with interstitial pneumonia or diffused symptomatic fibrosis of the lungs.
- Organ allogenic transplantation requiring immunosuppressive therapy. Any waiver of these inclusion and exclusion criteria must be approved by the investigator and the sponsor on a case-by case basis prior to enrolling the subject
- Known allergies, hypersensitivity, or intolerance to study drugs, chemotherapy drugs using this clinical trial
Key Trial Info
Start Date :
April 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT02284139
Start Date
April 1 2015
End Date
December 1 2017
Last Update
April 23 2018
Active Locations (1)
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1
Sung Yong Oh
Busan, South Korea, 602-715