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

This study is currently recruiting participants.
Verified November 2013 by Sun Yat-sen University
Sponsor:
Information provided by (Responsible Party):
Si-Yu Wang, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01588704
First received: April 25, 2012
Last updated: November 19, 2013
Last verified: November 2013
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Neoadjuvant Pemetrexed, Cisplatin and Bevacizumab in Unresectable, Locally Advanced Lung Adenocarcinoma

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • Resectability rate [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of participants with perioperative complications [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
  • Disease-free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: April 2012
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Neoadjuvant Bevacizumab
Four cycles of neoadjuvant chemotherapy with pemetrexed, cisplatin and bevacizumab.
Drug: Neoadjuvant Bevacizumab
Neoadjuvant Pemetrexed, Cisplatin and Bevacizumab followed by surgical resection
Other Names:
  • Pemetrexed (Alimta)
  • Bevacizumab (Avastin)

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01588704

Contacts
Contact: Si-Yu Wang, Doctor +86 20 87343439

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

No publications provided

Responsible Party: Si-Yu Wang, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01588704     History of Changes
Other Study ID Numbers: wsy002
Study First Received: April 25, 2012
Last Updated: November 19, 2013
Health Authority: China: Ethics Committee

Keywords provided by 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
Pemetrexed
Bevacizumab
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Antimetabolites, Antineoplastic
Antimetabolites
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on April 16, 2014