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Erlotinib Versus Pemetrexed as Second-Line Therapy in Treating Patients With Advanced Lung Adenocarcinoma

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ClinicalTrials.gov Identifier: NCT01565538
Recruitment Status : Completed
First Posted : March 28, 2012
Results First Posted : September 15, 2014
Last Update Posted : September 15, 2014
Sponsor:
Information provided by (Responsible Party):
Si-Yu Wang, Sun Yat-sen University

Brief Summary:
Both pemetrexed and erlotinib are second-line treatment options for patients with advanced non-small cell lung cancer. It is controversial that whether it is necessary to detect epidermal growth factor receptor (EGFR) mutation status for the EGFR-targeted therapy after the failure of standard chemotherapy. The role of EGFR gene copy number as a predictive marker remains controversial. Therefore, we investigate the efficacy of erlotinib and pemetrexed as second-line therapy in treating in patients with EGFR wild-type and EGFR FISH-positive advanced lung adenocarcinoma.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: Erlotinib Drug: Pemetrexed Phase 2

Detailed Description:
Standard first-line treatment for advanced-stage non-small cell lung cancer (NSCLC) usually consists of platinum-based doublet chemotherapy, but progression ultimately occurs for most patients. Second-line treatment options available to patients who suffer failure of first-line treatment include further chemotherapy (docetaxel and pemetrexed) or targeted therapy. Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) show great efficacy in patients with advanced NSCLC with EGFR mutation. High EGFR gene copy number was associated with great sensitivity and prolonged progression-free survival of NSCLC from EGFR-TKIs. This phase II study was designed to assess the efficacy and safety of erlotinib compared with pemetrexed as second-line treatment for EGFR wild-type and EGFR FISH-positive lung adenocarcinoma.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 123 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase II Trial of Erlotinib Versus Pemetrexed as Second-Line Therapy in Treating Patients With Advanced EGFR Wild-Type and EGFR FISH-Positive Lung Adenocarcinoma
Study Start Date : December 2008
Primary Completion Date : May 2012
Study Completion Date : May 2013


Arm Intervention/treatment
Experimental: Erlotinib
Erlotinib at the dose of 150 mg orally once a day continually until progression.
Drug: Erlotinib
150 mg Given orally
Other Name: Tarceva
Experimental: Pemetrexed
Pemetrexed at the dose of 500mg/m2 IV infusion every 3 weeks until progression.
Drug: Pemetrexed
500mg/m2 Given IV
Other Name: ALIMTA



Primary Outcome Measures :
  1. Progression-Free Survival [ Time Frame: From the date of randomization to the date of tumour progression or death from any cause, assessed until at least 12 months after randomization. ]
    Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.


Secondary Outcome Measures :
  1. Best Tumor Response [ Time Frame: From the date of randomization, assessed every 6 weeks, until at least 12 months after randomization. ]
    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

  2. Overall Survival [ Time Frame: From date of randomization until the date of death from any cause, assessed until at least 12 months after randomization. ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed Lung adenocarcinoma
  • Wld-type EGFR
  • Stage IIIB/IV
  • Failure to prior chemotherapy
  • Life expectancy of more than 3 months
  • Tissue sample desired for genomic study
  • Age ≥ 18 years
  • Performance status (WHO) < 3
  • Adequate bone marrow function (absolute neutrophil count > 1000/mm^3, platelet count > 100000/mm^3, hemoglobin > 9gr/mm^3)
  • Adequate liver (bilirubin < 1.5 times upper limit of normal and SGOT/SGPT < 2 times upper limit of normal) and renal function (creatinine < 2mg/dl)
  • Presence of two-dimensional measurable disease. The measurable disease should not have been irradiated
  • Informed consent

Exclusion Criteria:

  • Have previously received pemetrexed or TKIs
  • Other concurrent uncontrolled illness

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): NCT01565538


Locations
China, Guangdong
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Sponsors and Collaborators
Si-Yu Wang
Investigators
Principal Investigator: Si-Yu Wang, Doctor Sun Yat-sen University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Si-Yu Wang, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01565538     History of Changes
Other Study ID Numbers: wsy001
First Posted: March 28, 2012    Key Record Dates
Results First Posted: September 15, 2014
Last Update Posted: September 15, 2014
Last Verified: September 2014

Keywords provided by Si-Yu Wang, Sun Yat-sen University:
Cancer
Non-small-cell lung cancer
Adenocarcinoma
EGFR gene mutation
Chemotherapy
Pemetrexed
Erlotinib

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Erlotinib Hydrochloride
Pemetrexed
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors