Clinical trial NCT01588704: Neoadjuvant Pemetrexed, Carboplatin and Bevacizumab in Unresectable, Locally Advanced Lung Adenocarcinoma
Official title: A Phase II Study of Neoadjuvant Pemetrexed, Carboplatin and Bevacizumab in Unresectable, Locally Advanced Lung Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Cancer
Keywords: lung cancer
lung adenocarcinoma
bevacizumab
adjuvant chemotherapy
surgical resection rate
safety
feasibility
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2012-05-01
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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

Eligibility 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

Primary outcomes:
measure: Resectability rate
timeFrame: 3 months
Secondary outcomes:
measure: Number of participants with perioperative complications
timeFrame: 4 months
measure: Disease-free survival
timeFrame: 2 years
measure: Overall survival
timeFrame: 2 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Si-Yu Wang, Doctor
role: PRINCIPAL_INVESTIGATOR
References: