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

Phase 2

Completed

• Conditions: Pancreatic Cancer; Colorectal Cancer; Non-small Cell Lung Cancer
• Interventions: Drug: Arm EGF ointment 20 ppm; Drug: Arm Placebos; Drug: Arm EGF ointment 1ppm

• Registration Number: NCT02284139
• Lead Sponsor: Dong-A University Hospital

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). 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).

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 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.

Study Timeline

• Study First Submitted: 2014-11-03
• Study First Submitted QC: 2014-11-04
• Study First Posted: 2014-11-05
• Study Start: 2015-04
• Primary Completion: 2016-12
• Study Completion: 2017-12
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-19
• Last Update Posted: 2018-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm EGF ointment 20ppm	Arm EGF ointment 20 ppm	Arm EGF ointment 20ppm will be treated with EGF ointment of 20 ppm concentration
Placebo	Arm Placebos	Placebo ointment dose not contain EGF.
Arm EGF ointment 1ppm	Arm EGF ointment 1ppm	Arm EGF ointment 1ppm will be treated with EGF ointment of 1 ppm concentration

Primary Outcome Measures

Name	Time	Method
To estimate the response rate of EGF ointment	1 year	The effectiveness of the EGF ointment was defined as follows: 1. Grade 2, 3, or 4 ERSEs downgraded to ≤Grade 1 or; 2. Grade 3 or 4 ERSEs downgraded to Grade 2 and persisting for at least two weeks.

Secondary Outcome Measures

Name	Time	Method
Quality of Life	1 year	To evaluate the patients' Quality of Life (QoL) by Skin evaluation method (SKINDEX-16)

Trial Locations

Locations (1)

Sung Yong Oh; 🇰🇷 Busan, Korea, Republic of