Clinical trial NCT01174563: A Study on the Correlation Between Tarceva (Erlotinib) - Induced Rash and Efficacy in EGFR Mutated Participants With Advanced Non-Small Cell Lung Cancer Receiving First-Line Therapy
Official title: A Multi-Center Study Investigating the Correlation Between TARCEVA ®-Induced Rash and Efficacy Among EGFR-mutated NSCLC Patients Receiving First-line Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Squamous Non-Small Cell Lung Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
Collaborators: name: Clalit Health Services
First posted: 2010-08-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This open-label, single arm study will assess the correlation between Tarceva (erlotinib)-induced rash and efficacy in participants with inoperable, locally advanced, recurrent or metastatic non-small cell lung cancer (NSCLC) receiving first-line therapy for advanced disease. Participants will receive Tarceva at a dose of 150 mg daily orally, with dose adjustments according to protocol depending on toxicity. Anticipated time on study treatment is until disease progression, unacceptable toxicity, or withdrawal due to any reason.


Eligibility criteria: Inclusion Criteria:

* Adult participants, \>/= 18 years of age
* Inoperable, locally advanced, recurrent or metastatic (Stage IIIB or IV) non-small cell lung cancer (NSCLC)
* Presence of epidermal growth factor receptor (EGFR) mutations
* Previously untreated with any systemic anti-neoplastic therapy for advanced disease
* Last dose of a prior systemic anti-neoplastic therapy for early-stage disease \>/= 4 weeks before study start, and patient recovered from acute toxicities of any previous therapy
* A life expectancy of at least 12 weeks
* Able to comply with the study and its follow-up procedures
* Female participants had to be postmenopausal (24 months of amenorrhea), surgically sterile or agree to use a physical method of contraception. Male participants had to be surgically sterile or agree to use a barrier method of contraception. Women with an intact uterus (unless amenorrhoeic for the last 24 months) had to have a negative pregnancy test (urine or serum) within 3 days prior to erlotinib treatment initiation in the study. Male and female participants had to use effective contraception during the study and for a period of 90 days following the last administration of erlotinib. Acceptable methods of contraception included an established hormonal therapy or intrauterine device for females, and the use of a barrier contraceptive (i.e. diaphragm or condoms)

Exclusion Criteria:

* Pregnant or breast feeding women
* Granulocyte count \<1.5 x 109/L and platelet count \<100\*10\^9/L
* Serum bilirubin \>1.5 upper limit of normal (ULN)
* Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \> 2 \* ULN (or \>5 \* ULN if clearly attributable to liver metastasis)
* Serum creatinine \>1.5 ULN or creatinine clearance \<60 mL/min
* Known allergy or other adverse reaction to study drug or any other related compound
* Any significant unstable systemic disease (including active infection, grade 4 hypertension, unstable angina, congestive heart failure, hepatic, renal or metabolic disease)
* Prior systemic anti-neoplastic therapy with HER1/EGFR inhibitors (as small molecule or monoclonal antibody therapy)
* Newly diagnosed or not yet definitively treated (i.e. stable disease \>/= 2 months) CNS metastases or spinal cord compression
* Any significant ophthalmological abnormality, especially those likely to increase the risk of corneal epithelial lesions (the use of contact lenses is not recommended during the study)
* Participants who could not take oral medication, who required intravenous alimentation, had had prior surgical procedures affecting absorption, or had active peptic ulcer disease
* Active cancer other than NSCLC, except for basal cell or squamous cell carcinomas of the skin that have been excised and cured

Primary outcomes:
measure: Progression-free Survival (PFS) According to Grade of Rash
timeFrame: Day 1 of treatment period until disease progression or death (approximately up to 67 months)
Secondary outcomes:
measure: Percentage of Participants With Erlotinib Dose Reductions Due to Rash Grade 3-4
timeFrame: Day 1 of treatment period until disease progression or death (approximately up to 67 months)
measure: Progression-Free Survival (PFS) in Participants With Erlotinib Dose Reductions Due to Rash Grade 3-4
timeFrame: Day 1 of treatment period until disease progression or death (approximately up to 67 months)
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Haemek Hospital; Oncology
city: Ashkelon
country: Israel
facility: Barzilai; Oncology
city: Beer Sheva
country: Israel
facility: Soroka Medical Center; Oncology Dept
city: Haifa
country: Israel
facility: Carmel Hospital; Oncology Unit
city: Haifa
country: Israel
facility: Rambam Medical Center; Oncology
city: Holon
country: Israel
facility: Wolfson Hospital; Oncology
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center; Oncology Dept
city: Jerusalem
country: Israel
facility: Hadassah Ein Karem Hospital; Oncology Dept
city: Kfar-Saba
country: Israel
facility: Meir Medical Center; Oncology
city: Nahariya
country: Israel
facility: Nahariya Hospital; Oncology
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center; Oncology Dept
city: Rehovot
country: Israel
facility: Kaplan Medical Center; Oncology Inst.
city: Sefad
country: Israel
facility: Ziv Medical Center; Oncology Department
city: Tel Aviv
country: Israel
facility: Sourasky / Ichilov Hospital; Oncology Department
city: Tiberias
country: Israel
facility: Poria Hospital; Oncology
city: Zerifin
country: Israel
facility: Assaf Harofeh; Oncology
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: