Title

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

    Phase 2
  • Study Type

    Interventional
  • Status

    Unknown status
  • Study Participants

    30
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.
Study Started
Aug 31
2013
Primary Completion
Dec 30
2019
Anticipated
Study Completion
Dec 30
2019
Anticipated
Last Update
Feb 14
2018

Drug Bevacizumab

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

  • Other names: Avastin (Genentech/Roche)

Drug Dexamethasone

Dexamethasone 10mg iv d 1-10, then 5mg iv d11-15, 2.5mg iv d16-20

study group Experimental

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

control Active Comparator

Dexamethasone 10mg iv d 1-10, then 5mg iv d11-15, 2.5mg iv d16-20

Criteria

Inclusion Criteria:

clinical diagnosed cancer treatment-induced acute pulmonary fibrosis

Exclusion Criteria:

chronic pulmonary fibrosis and infection-induced pulmonary fibrosis
active bleeding
uncontrolled high blood pressure
unstable systemic disease
prior exposure to VEGF inhibitor
No Results Posted