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

NCT01565538 | Completed Phase 2 Results

• 1 other identifier: wsy001
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Keywords

Cancer; Non-small-cell lung cancer; Adenocarcinoma; EGFR gene mutation; Chemotherapy; Pemetrexed; Erlotinib

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival

  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.

  From the date of randomization to the date of tumour progression or death from any cause, assessed until at least 12 months after randomization.

Secondary Outcomes (2)

• Best Tumor Response

  From the date of randomization, assessed every 6 weeks, until at least 12 months after randomization.

• Overall Survival

  From date of randomization until the date of death from any cause, assessed until at least 12 months after randomization.

Study Arms (2)

Erlotinib

EXPERIMENTAL

Erlotinib at the dose of 150 mg orally once a day continually until progression.

Drug: Erlotinib

Pemetrexed

EXPERIMENTAL

Pemetrexed at the dose of 500mg/m2 IV infusion every 3 weeks until progression.

Drug: Pemetrexed

Interventions

Erlotinib DRUG

150 mg Given orally

Also known as: Tarceva

Erlotinib

Pemetrexed DRUG

500mg/m2 Given IV

Also known as: ALIMTA

Pemetrexed

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Si-Yu Wang: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Related Publications (1)

• Li N, Ou W, Yang H, Liu QW, Zhang SL, Wang BX, Wang SY. A randomized phase 2 trial of erlotinib versus pemetrexed as second-line therapy in the treatment of patients with advanced EGFR wild-type and EGFR FISH-positive lung adenocarcinoma. Cancer. 2014 May 1;120(9):1379-86. doi: 10.1002/cncr.28591. Epub 2014 Jan 30.

  PMID: 24481719 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma

Interventions

Erlotinib Hydrochloride; Pemetrexed

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Guanine; Hypoxanthines; Purinones; Purines; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Results Point of Contact

• Title: Dr. Si-Yu Wang
• Organization: Sun Yat-sen University Cancer Center

wsysums@163.net

020-87343439

Study Officials

• Si-Yu Wang, Doctor

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 22, 2012
• First Posted: March 28, 2012
• Study Start: December 1, 2008
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2013
• Last Updated: September 15, 2014
• Results First Posted: September 15, 2014

Record last verified: 2014-09

Locations

CN (1)