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NCT Number: NCT01588704

Neoadjuvant Pemetrexed, Carboplatin and Bevacizumab in Unresectable, Locally Advanced Lung Adenocarcinoma

The prognosis of patients with unresectable, locally advanced non-small cell lung cancer (NSCLC) is poor. Chemoradiotherapy is the main treatment modality for this disease. The newer drug regimens can be expected to improve survival in this subset of NSCLC patients. Modern targeted therapies have enhanced the outcomes of lung cancer treatment, especially for advanced NSCLC. Among the targeted approaches for the inhibition of angiogenesis is bevacizumab, a monoclonal antibody that represses vascular endothelial growth factor (VEGF). Bevacizumab in combination with platinum-based chemotherapy used as neoadjuvant chemotherapy may change the previous treatment modality. It allows some lung cancer patients to be downstaged to surgery rather than radiotherapy. Thus, survival of these patients may be improved.

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Key information

Conditions

Lung Cancer Adenocarcinoma Adenocarcinoma of Lung Carcinoma Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

About this study

This trial investigates the role of neoadjuvant pemetrexed, carboplatin and bevacizumab in unresectable, locally advanced lung adenocarcinoma.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Histologically confirmed unresectable, locally advanced (III A (bulky N2), III B) lung adenocarcinoma
  • No previous chemotherapy, radiotherapy, surgery or biological therapy for lung cancer
  • Adequate organ and bone marrow function

Exclusion criteria

  • Prior chemotherapy or radiation therapy for NSCLC
  • Prior treatment with bevacizumab or other agents specifically targeting vascular endothelial growth factor (VEGF)
  • Patients with known hypersensitivity to other recombinant human antibodies
  • History of stroke or transient ischemic attack (TIA).
  • History of myocardial infarction or unstable angina within the past 12 months.
  • Other serious illness or medical condition including unstable cardiac disease requiring treatment, history of significant neurologic or psychiatric disorders (including psychotic disorders, dementia, or seizures), symptomatic diverticulitis, or active uncontrolled infection.
  • Women who are pregnant or breast-feeding

Treatment and study plan

Neoadjuvant Bevacizumab

Drug

Neoadjuvant Pemetrexed, Carboplatin and Bevacizumab followed by surgical resection

Other names: Pemetrexed (Alimta), Bevacizumab (Avastin)

Primary outcomes

  1. Resectability rate

    Time frame: 3 months

Secondary outcomes

  1. Number of participants with perioperative complications

    Time frame: 4 months

  2. Disease-free survival

    Time frame: 2 years

  3. Overall survival

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Si-Yu Wang

Other

Registry information

Official study title

A Phase II Study of Neoadjuvant Pemetrexed, Carboplatin and Bevacizumab in Unresectable, Locally Advanced Lung Adenocarcinoma

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
May 1, 2012
Registry last updated
Jan 22, 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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