EGF Ointment for Erlotinib Skin Lesion

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dong-A University Hospital
• Treatments: Erlotinib Hydrochloride; Mitogens

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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