Status:
COMPLETED
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
Lead Sponsor:
Hoffmann-La Roche
Collaborating Sponsors:
Clalit Health Services
Conditions:
Non-Squamous Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 23 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2016
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01174563
Start Date
May 23 2011
End Date
December 20 2016
Last Update
September 17 2018
Active Locations (16)
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1
Haemek Hospital; Oncology
Afula, Israel, 18101
2
Barzilai; Oncology
Ashkelon, Israel, 78278
3
Soroka Medical Center; Oncology Dept
Beersheba, Israel, 8410101
4
Carmel Hospital; Oncology Unit
Haifa, Israel, 34362