Pilot Trial of EGF Ointment for the Patients With EGFR-i Related Skin Side Effects

Colorectal Cancer Clinical Trial

Official title:

Pilot Trial of Epidermal Growth Factor (EGF) Ointment for the Patients With Epidermal Growth Factor Receptor (EGFR) Inhibitor Related Skin Side Effects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02284139
• Other study ID #: DAUH-14-211
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 3, 2014
• Last updated: April 19, 2018
• Start date: April 2015
• Est. completion date: December 2017

Study information

• Verified date: April 2018
• Source: Dong-A University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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). Dermatological reactions can cause significant physical and psycho-social discomfort to patients. In the present study, the investigators evaluated the effect of epidermal growth factor (EGF) ointment on EGFR inhibitor-related skin side effects (ERSEs).

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 gemcitabine and erlotinib combination chemotherapy and CRC treated with cetuximab and5-Fluorouracil (5-FU)+Irinotecan+leucovorin(LV) (FOLFIRI), 5-FU+Oxaliplatin+LV (FOLFOX) and sufficient liver, kidney, and bone marrow function to undergo treatment. All the patients had Grade ≥2 ERSEs according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) v. 4.03.

The patients will be randomized 3 groups; Placebo group, Arm 1, and Arm 2. Arm 1 will be treated with 1ppm concentration EGF ointment. Arm 2 will be treated with 20ppm concentration EGF ointment. And placebo group will be treated with 0ppm concentration EGF ointment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. Age: older than 20

2. Eastern Cooperative Oncology Group (ECOG) performance status 0 -2

3. Histologically confirmed lung cancer, pancreatic cancer, or colon cancer

4. 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)

5. Patients who have EGFR inhibitor related skin side effects (ERSE) Gr=2 (NCICTC V4.0)

6. A patient with the willingness to comply with the study protocol during the study period and capable of complying with it

7. 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 Criteria:

1. A patient with previous active or passive immunotherapy

2. A pregnant or lactating patient

3. 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.)

4. 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

5. A patient with history of dermatologic care (except transient urticaria) within 4 weeks

6. 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

7. A patient with interstitial pneumonia or diffused symptomatic fibrosis of the lungs.

8. 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

9. Known allergies, hypersensitivity, or intolerance to study drugs, chemotherapy drugs using this clinical trial

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Colorectal Cancer
• Colorectal Neoplasms
• Non-small Cell Lung Cancer
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Arm EGF ointment 1ppm
EGF Ointment 1ppm evenly apply to skin lesion every 12 hr/ day
• Arm EGF ointment 20 ppm
EGF Ointment 20 evenly apply to skin lesion every 12 hr/ day
• Arm Placebos
EGF Ointment 0ppm evenly apply to skin lesion every 12 hr/ day

Locations

Country	Name	City	State
Korea, Republic of	Sung Yong Oh	Busan

Sponsors (1)

Lead Sponsor	Collaborator
Dong-A University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To estimate the response rate of EGF ointment	The effectiveness of the EGF ointment was defined as follows: Grade 2, 3, or 4 ERSEs downgraded to =Grade 1 or; Grade 3 or 4 ERSEs downgraded to Grade 2 and persisting for at least two weeks.	1 year
Secondary	Quality of Life	To evaluate the patients' Quality of Life (QoL) by Skin evaluation method (SKINDEX-16)	1 year