Phase II Study of Bevasizumab in the Management of Acute Radiation-induced and Chemotherapy-induced Pulmonary Fibrosis

Who is this study for? Patients with acute radiation-induced and chemotherapy-induced pulmonary fibrosis
What treatments are being studied? Bevacizumab
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Due to the radiosensitivity of the lung, radiation-induced and chemotherapy-induced pneumonitis and pulmonary fibrosis are frequent happened following cancer therapy. It not only compromise cancer treatment, but also influence patient's life qualities and even death. there are no specific treatment modalities for this treatment-induced complication. Bevasizumab (Avastin), a VEGF inhibitor, can attenuate serum high expression VEGF and pulmonary permeability, maybe effective in the control acute pulmonary fibrosis. Patients will be randomized to receive Bevasizumab (7mg/kg iv) on day one and 21, followed by Dexamethasone (10mg iv d 1-10, then 5mg iv d11-15, 2.5mg iv d16-20) or Dexamethasone alone. The thoracic CT, plasma TNF-a, IL-6, VEGF and C-reactive protein are accessed on before treatment, 24 hours after Bevasizumab, 7 days, 4 and 8 weeks. the target sample size is 30 cases.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• clinical diagnosed cancer treatment-induced acute pulmonary fibrosis

Locations
Other Locations
China
Qingdao Central Hospital
RECRUITING
Qingdao
Contact Information
Primary
youxin ji, md
ji6677@gmail.com
86532-68665078
Time Frame
Start Date: 2013-08-01
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 30
Treatments
Experimental: study group
Bevacizumab 7mg/kg iv on day1 and 21, followed by Dexamethasone 10mg iv d 1-10, then 5mg iv d11-15, 2.5mg iv d16-20
Active_comparator: control
Dexamethasone 10mg iv d 1-10, then 5mg iv d11-15, 2.5mg iv d16-20
Related Therapeutic Areas
Sponsors
Leads: Qingdao Central Hospital

This content was sourced from clinicaltrials.gov

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