Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 54 of 131 for:    Pancreatic Cancer | ( Map: South Korea )

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02284139
Recruitment Status : Completed
First Posted : November 5, 2014
Last Update Posted : April 23, 2018
Sponsor:
Information provided by (Responsible Party):
Sung Yong Oh, 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).

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Pancreatic Cancer Colorectal Cancer Drug: Arm EGF ointment 1ppm Drug: Arm EGF ointment 20 ppm Drug: Arm Placebos Phase 2 Phase 3

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Trial of Epidermal Growth Factor (EGF) Ointment for the Patients With Epidermal Growth Factor Receptor (EGFR) Inhibitor Related Skin Side Effects
Actual Study Start Date : April 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo ointment dose not contain EGF.
Drug: Arm Placebos
EGF Ointment 0ppm evenly apply to skin lesion every 12 hr/ day
Other Name: Saesal yeongo 0 (EGF ointment 0 ppm)

Active Comparator: Arm EGF ointment 1ppm
Arm EGF ointment 1ppm will be treated with EGF ointment of 1 ppm concentration
Drug: Arm EGF ointment 1ppm
EGF Ointment 1ppm evenly apply to skin lesion every 12 hr/ day
Other Name: Saesal yeongo 1 (EGF ointment 1ppm)

Active Comparator: Arm EGF ointment 20ppm
Arm EGF ointment 20ppm will be treated with EGF ointment of 20 ppm concentration
Drug: Arm EGF ointment 20 ppm
EGF Ointment 20 evenly apply to skin lesion every 12 hr/ day
Other Name: Saesal yeongo 20 (EGF ointment 20 ppm)




Primary Outcome Measures :
  1. To estimate the response rate of EGF ointment [ Time Frame: 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 :
  1. Quality of Life [ Time Frame: 1 year ]
    To evaluate the patients' Quality of Life (QoL) by Skin evaluation method (SKINDEX-16)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02284139


Locations
Layout table for location information
Korea, Republic of
Sung Yong Oh
Busan, Korea, Republic of, 602-715
Sponsors and Collaborators
Dong-A University Hospital
Investigators
Layout table for investigator information
Principal Investigator: SUNG YONG OH, M.D. Dong-A University Hospital

Layout table for additonal information
Responsible Party: Sung Yong Oh, Department of Internal Medicine, Dong-A University Hospital, Dong-A University Hospital
ClinicalTrials.gov Identifier: NCT02284139     History of Changes
Other Study ID Numbers: DAUH-14-211
First Posted: November 5, 2014    Key Record Dates
Last Update Posted: April 23, 2018
Last Verified: April 2018
Keywords provided by Sung Yong Oh, Dong-A University Hospital:
EGF ointment
EGFR inhibitor
Skin side effect