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

Dong-A University Hospital

Status and phase: Completed; Phase 3; Phase 2

Conditions: Non-small Cell Lung Cancer; Colorectal Cancer; Pancreatic Cancer

Treatments: Drug: Arm EGF ointment 1ppm; Drug: Arm Placebos; Drug: Arm EGF ointment 20 ppm

Study type: Interventional

Funder types: Other

Identifiers

NCT02284139

DAUH-14-211

Details and patient eligibility

About

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).

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo ointment dose not contain EGF.

Treatment:

Drug: Arm Placebos

Arm EGF ointment 1ppm

Active Comparator group

Description:

Arm EGF ointment 1ppm will be treated with EGF ointment of 1 ppm concentration

Treatment:

Drug: Arm EGF ointment 1ppm

Arm EGF ointment 20ppm

Active Comparator group

Description:

Arm EGF ointment 20ppm will be treated with EGF ointment of 20 ppm concentration

Treatment:

Drug: Arm EGF ointment 20 ppm