EGF Ointment for Erlotinib Skin Lesion

NCT01593995 | Completed Phase 2 DMC

• 1 other identifier: DAU-12-01(ML25441)
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

Epidermal growth factor receptor-tyrosin kinase inhibitor (EGFR-TKI, Erlotinib) has demonstrated its efficacy in patients with non-small cell lung cancer and pancreatic cancer. But, their use is associated with dermatologic reactions of varying severity. Incidence of Erlotinib related skin effect (ERSE) was reported \~75% in NSCLC and pancreatic cancer phase III trials. Even though the dermatologic reactions could be a surrogated marker, it may be cause of dose modification. Also, it could give significant physical and psycho-social discomfort to patients. However, there is still a wide variety of drugs used- including, steroid, antibiotics, and vitamin D without any clear evidence based management recommendation. The role of epidermal growth factor (EGF) has been extensively investigated in normal and pathological wound healing. It is implicated in keratinocyte migration, fibroblast function and the formation of granulation tissue. The first growth factor to be isolated growth factor therapy has progressed into clinical practice in the treatment of wounds. Therefore, the investigators propose an epidermal growth factor ointment apply for patients with Erlotinib related skin effects.

Conditions

Non-small Cell Lung Cancer; Pancreatic Cancer

Keywords

Erlotinib; Skin side effect; EGF ointment

Outcome Measures

Primary Outcomes (1)

• Improvement of skin lesion grading by NCI-CTC v3.0

  4 weeks

Study Arms (1)

EGF ointment

EXPERIMENTAL

Drug: Epidermal growth factor (EGF) ointment

Interventions

Epidermal growth factor (EGF) ointment DRUG

EGF Ointment evenly apply to skin lesion every 12 hr/ day. If the skin lesion has been no improvement even though EGF ointment applied for 8 weeks, stopped study and assess it as "no effect"

Also known as: Sesal Yeongo

EGF ointment

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age :older than 20
• ECOG performance status 0 -2
• Histologically lung cancer or Pancreatic Cancer
• Patients take Erlotinib following the reason Clinical failure of the prior therapy locally advanced or metastatic NSCLC The 1ST line using in combination with Gemcitabine for locally advanced, unresectable or metastatic Pancreatic Cancer(Adenocarcinoma)
• Patients who have Erlotinib-treatment related skin lesions Gr≥2 (NCI-CTC V3.0).
• A patient with at least one measurable primary lesion of which the diameter is confirmed to be 10mm in Spiral CT or multidetector CT (MD CT), or 20 mm or longer in conventional CT (it should be used by a consistent method during the study period).
• The following laboratory test results:
• Creatinine clearance ≥ 60ml/min Number of absolute neutrophil counts (ANC) \> 1.5 x 109/L Number of thrombocytes \> 100 x 109/L Total bilirubin \< 2x upper limit of normal ALAT, ASAT \< 3 x upper limit of normal (in case of liver metastasis, 5 x upper limit of normal) Alkaline phosphatase \< 3 x upper limit of normal (in case of liver metastasis, 5 x upper limit of normal)
• 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.

You may not qualify if:

• 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.
• Known allergies, hypersensitivity, or intolerance to Study drugs, Chemotherapy drugs using this Clinical trial

Sponsors & Collaborators

• Dong-A University Hospital: lead

Study Sites (1)

Dong-A University Hospital

Busan, 602-715, South Korea

Location

Related Publications (1)

• Hwang IG, Kang JH, Oh SY, Lee S, Kim SH, Song KH, Son C, Park MJ, Kang MH, Kim HG, Lee J, Park YS, Sun JM, Kim HJ, Kim CK, Yi SY, Jang JS, Park K, Kim HJ. Phase II trial of epidermal growth factor ointment for patients with Erlotinib-related skin effects. Support Care Cancer. 2016 Jan;24(1):301-309. doi: 10.1007/s00520-015-2783-9. Epub 2015 Jun 4.

  PMID: 26041481 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Pancreatic Neoplasms

Interventions

Epidermal Growth Factor; Ointments

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; EGF Family of Proteins; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Sung Yong Oh, M.D.,Ph.D.

  Onclogy Division, Dong-A University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Internal Medicine

Study Record Dates

• First Submitted: May 5, 2012
• First Posted: May 8, 2012
• Study Start: May 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: October 1, 2014
• Last Updated: November 4, 2014

Record last verified: 2014-11

Locations

KR (1)