Prophylactic EVOZAC® Calming Skin Spray for EGFR-TKIs Associated Rash Eruption in NSCLC

NCT01528488 | Completed Phase 2

• 1 other identifier: EVOZAC20110210
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

The epidermal growth factor receptor (EGFR) has become an important target for cancer therapy, and the small molecular tyrosine kinase inhibitors (EGFR-TKIs) have played an important role in the treatment of non-small cell lung cancer (NSCLC). What accompanies with the encouraging efficacy in NSCLC is the common side effects, of which the most common one is the specific papular and pustular acne-like rash which affects mainly the face, scalp, and upper torso. But till now, no medicament has been proved effective enough to treat or prevent the EGFR-TKIs associated rash. The EVOZAC® Calming Skin Spray has shown acceptable activity at the rash prevention in our preliminary study, so the investigators conduct the randomized, double-blind, controlled trial to evaluate the efficacy and safety of EVOZAC® Calming Skin Spray in prevention of EGFR-TKIs associated rash in NSCLC.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Lesion counts in total face at completion of the study period (week 4)

  12 months

Study Arms (2)

EVOZAC

EXPERIMENTAL

EVOZAC should be sprayed to the skin of the total face three times per day.

Other: EVOZAC Calming Skin Spray

Physiological saline

PLACEBO COMPARATOR

Physiological saline should be sprayed to the total face three times per day.

Other: Physiological saline

Interventions

EVOZAC Calming Skin Spray OTHER

EVOZAC Calming Skin Spray should be sprayed to the skin in the total face, three times per day

EVOZAC

Physiological saline OTHER

Physiological saline was used as the placebo of EVOZAC® Calming Skin Spray and should be also sprayed on the total face, three times per day

Physiological saline

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven NSCLC diagnosis
• Life expectancy over four weeks
• absolute neutrophil count ≥ 2.0X109/L, Pt ≥ 100X109/L, hemoglobin ≥ 90g/l
• With normal hepatic function(AST, ALT \< 2.5 x upper limit of normal , and Total bilirubin ≤ upper limit of normal)
• Suitable for EGFR-TKIs treatment and expectant duration over four weeks
• No specific therapies received within 4 weeks prior to enrollment which may induce similar skin reaction,such as Cetuximab, Sorafenib, Avastin.
• With a pre-existing peripheral neuropathy (National Cancer Institute Common Toxicity Criteria for Adverse Events \[NCI-CTC\] grade ≥ 3)
• No other concomitant therapy referred to the face skin during the study
• Signed and dated informed consent

You may not qualify if:

• Performance status ≥ 3(ECOG)
• Pregnant or breast-feeding patients
• The lesion counts can't be evaluated due to concomitant diseases or other conditions
• Not suitable for EGFR-TKIs treatment

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Department of Medical Oncology,Cancer Center of Sun Yat-Sen University

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• li zhang, MD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: February 3, 2012
• First Posted: February 8, 2012
• Study Start: December 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: July 1, 2013
• Last Updated: November 5, 2013

Record last verified: 2013-11

Locations

CN (1)