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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01588704
First Posted: May 1, 2012
Last Update Posted: January 22, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Si-Yu Wang, Sun Yat-sen University
  Purpose
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.

Condition Intervention Phase
Lung Cancer Drug: Neoadjuvant Bevacizumab Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Neoadjuvant Pemetrexed, Carboplatin and Bevacizumab in Unresectable, Locally Advanced Lung Adenocarcinoma

Resource links provided by NLM:


Further study details as provided by Si-Yu Wang, Sun Yat-sen University:

Primary Outcome Measures:
  • Resectability rate [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • Number of participants with perioperative complications [ Time Frame: 4 months ]
  • Disease-free survival [ Time Frame: 2 years ]
  • Overall survival [ Time Frame: 2 years ]

Enrollment: 42
Study Start Date: April 2012
Study Completion Date: April 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Neoadjuvant Bevacizumab
Four cycles of neoadjuvant chemotherapy with pemetrexed, carboplatin and bevacizumab.
Drug: Neoadjuvant Bevacizumab
Neoadjuvant Pemetrexed, Carboplatin and Bevacizumab followed by surgical resection
Other Names:
  • Pemetrexed (Alimta)
  • Bevacizumab (Avastin)

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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): NCT01588704


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
  More Information

Responsible Party: Si-Yu Wang, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01588704     History of Changes
Other Study ID Numbers: GASTO1001
wsy002 ( Other Identifier: Guangdong Province Association Study of Thoracic Oncology )
First Submitted: April 25, 2012
First Posted: May 1, 2012
Last Update Posted: January 22, 2015
Last Verified: January 2015

Keywords provided by Si-Yu Wang, Sun Yat-sen University:
lung cancer
lung adenocarcinoma
bevacizumab
adjuvant chemotherapy
surgical resection rate
safety
feasibility

Additional relevant MeSH terms:
Adenocarcinoma
Lung Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Bevacizumab
Carboplatin
Pemetrexed
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors