A Study on the Correlation Between Tarceva (Erlotinib) - Induced Rash and Efficacy in EGFR Mutated Patients With Advanced Non-Small Cell Lung Cancer Receiving First-Line Therapy

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Clalit Health Services
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01174563
First received: August 2, 2010
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

This open-label, single arm study will assess the correlation between Tarceva (erlotinib)-induced rash and efficacy in patients with inoperable, locally advanced, recurrent or metastatic non-small cell lung cancer (NSCLC) receiving first-line therapy for advanced disease. Patients 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 occurs.


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: erlotinib [Tarceva]
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-Center Study Investigating the Correlation Between TARCEVA ®-Induced Rash and Efficacy Among EGFR-mutated NSCLC Patients Receiving First-line Therapy

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression-free survival according to grade of rash; tumor assessments by computer tomography (CT) or magnetic resonance imaging (MRI) according to RECIST criteria [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Rate of Tarceva dose reductions due to grade III-IV rash [ Time Frame: approximately 3 years ] [ Designated as safety issue: Yes ]
  • Progression-free survival in patients with Tarceva dose reductions due to grade III-IV rash; tumor assessments by CT or MRI according to RECIST criteria [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: February 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm Drug: erlotinib [Tarceva]
150 mg orally daily, with dose-reductions to 100 mg or 50 mg orally daily according to protocol

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients, >/= 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

Exclusion Criteria:

  • Pregnant or breast feeding women
  • Known allergy or other adverse reaction to study drug or any other related compound
  • 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)
  • Active cancer other than NSCLC, except for basal cell or squamous cell carcinomas of the skin that have been excised and cured
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01174563

Locations
Israel
Afula, Israel, 18101
Ashkelon, Israel, 78278
Beer Sheva, Israel, 8410101
Haifa, Israel, 34362
Haifa, Israel, 34354
Holon, Israel, 58100
Jerusalem, Israel, 91120-01
Jerusalem, Israel, 91031
Kfar-Saba, Israel, 4428164
Nahariya, Israel, 22100
Ramat Gan, Israel, 52620-00
Rehovot, Israel, 7610001
Sefad, Israel, 13100
Tel Aviv, Israel, 64239-06
Tiberias, Israel, 15208
Zerifin, Israel, 70300
Sponsors and Collaborators
Hoffmann-La Roche
Clalit Health Services
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01174563     History of Changes
Other Study ID Numbers: ML25200
Study First Received: August 2, 2010
Last Updated: April 7, 2014
Health Authority: Israel: Minisrty of Health

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Erlotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014