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Completed

NCT Number: NCT01578668

Erlotinib Plus Pemetrexed to Treat Lung Adenocarcinoma With Brain Metastases

The purpose of this study is to determine whether erlotinib plus pemetrexed, cisplatin are effective and safe in treating lung adenocarcinoma with brain metastases.

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Key information

Conditions

Lung Adenocarcinoma Adenocarcinoma Adenocarcinoma of Lung Brain Diseases Brain Metastases Brain Neoplasms Carcinoma Central Nervous System Diseases Central Nervous System Neoplasms Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Nervous System Diseases Nervous System Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The first affiliated hospital of Guangzhou MC

Guangzhou, Guangdong, 510120, China

About this study

Non-small lung cancer (NSCLC) is the leading cause of death in the world. Brain metastases are a frequent complication of NSCLC, especially in lung adenocarcinoma. 30-50% or more these patients will develop brain metastases at first time or during the treatment. Limited treatment options, whole brain radiotherapy (WBRT) combined with or without stereotactic radiosurgery (SRS) as the primary treatment approach, are available for brain metastases patients with poor survival. So the availability of effective therapies are therefore of great importance. Currently, two agents (erlotinib and pemetrexed) are reported more effective in lung adenocarcinoma patients with brain metastases. The heterogeneity of NSCLC tumors provides a strong rationale for using combination therapy with targeted agents that have different mechanisms of action, moreover different combination offering synergistic effects. So we investigate if erlotinib plus pemetrexed, cisplatin are effective and safe in treating lung adenocarcinoma with brain metastases.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histological or cytological diagnosis of lung adenocarcinoma histology with brain metastases
  • 18 years or older
  • Eastern Cooperative Oncology Group (ECOG) Performance Status no more than 3 (poor PS caused by neurological symptom)
  • Appraisable intracranial disease, the presence of at least one lesion, and the longest diameter > 5 mm by brain MRI
  • Haemoglobin 10.0 g/dl, Absolute neutrophil count (ANC) 1.5^9/L, platelets 100 x 10^9/L
  • Total bilirubin 1.5 x upper limit of normal (ULN)
  • alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 x ULN in the absence of liver metastases, or < 5 x ULN in case of liver metastases
  • Creatinine clearance 60ml/min (calculated according to Cockcroft-gault formula)
  • If received brain radiotherapy, patients included at least 8 weeks after the end of radiotherapy.

Exclusion criteria

  • Mixed non-adenocarcinoma cell lung cancer histology
  • Previous treatment with pemetrexed or tarceva
  • Be allergic to pemetrexed or tarceva

Treatment and study plan

Erlotinib

Drug

150 mg given orally (po), daily (QD), starting on the 4th day of each cycle, ending on the 21th day before the next cycle, and until disease PD

Other names: Tarceva

Pemetrexed

Drug

500 mg/m² intravenous (iv) over 15 minutes on the first day of each 21-day cycle until disease progression (PD) or unacceptable toxicity or no more than 6 cycles

Other names: ALIMTA

Cisplatin

Drug

cisplatin 20mg/m² iv on the 1st-3rd day (if PS<2) or 30 mg iv on the 1st-2nd day (if PS=2 or 3)of each cycle until PD or unacceptable toxicity or no more than 6 cycles

Other names: platinum

Primary outcomes

  1. The objective response rate of brain metastases

    Time frame: Patients will be followed for an expected average of 6 weeks

Secondary outcomes

  1. The disease control response rate of disease

    Time frame: Patients will be followed for an expected average of 6 weeks

  2. Progression-free survival of patients

    Time frame: 2 years after first treatment

  3. Number of participants with adverse events as a measure of safety

    Time frame: 2 years after first treatment

  4. Overall survival of patients

    Time frame: 3 years after the first treatment

Sponsors and collaborators

Lead sponsor

Guangzhou Medical University

Other

Registry information

Official study title

Phase 2 Study of Erlotinib Plus Pemetrexed/Cisplatin Treating Lung Adenocarcinoma With Brain Metastases

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Apr 17, 2012
Registry last updated
Jan 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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