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

This study is currently recruiting participants.
Verified April 2012 by Sun Yat-sen University
Sponsor:
Information provided by (Responsible Party):
Siyu Wang, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01588704
First received: April 25, 2012
Last updated: April 30, 2012
Last verified: April 2012

April 25, 2012
April 30, 2012
April 2012
May 2014   (final data collection date for primary outcome measure)
Resectability rate [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01588704 on ClinicalTrials.gov Archive Site
Perioperative complications [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
Perioperative complications, such as major hemoptysis, wound healing complications, and infection.
Same as current
Not Provided
Not Provided
 
Neoadjuvant Pemetrexed, Cisplatin and Bevacizumab in Unresectable, Locally Advanced Lung Adenocarcinoma
A Phase II Study of Neoadjuvant Pemetrexed, Cisplatin 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.

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

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lung Cancer
Drug: Neoadjuvant Bevacizumab
Neoadjuvant Pemetrexed, Cisplatin and Bevacizumab followed by surgical resection
Other Names:
  • Pemetrexed (Alimta)
  • Bevacizumab (Avastin)
Experimental: Neoadjuvant Bevacizumab
Four cycles of neoadjuvant chemotherapy with pemetrexed, cisplatin and bevacizumab.
Intervention: Drug: Neoadjuvant Bevacizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
36
Not Provided
May 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact: Siyu Wang, Doctor +86 20 87343439
China
 
NCT01588704
wsy002
No
Siyu Wang, Sun Yat-sen University
Siyu Wang
Not Provided
Principal Investigator: Siyu Wang, Doctor Sun Yat-sen University
Sun Yat-sen University
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP