A Phase II Study of Cediranib as Palliative Treatment in Patients With Symptomatic Malignant Ascites or Pleural Effusion
Malignant ascites is a difficult clinical problem. Increasing intra-abdominal pressure
resulting from fluid accumulation may cause anorexia, sleep disturbance, pain, dyspnoea,
abdominal distension, fatigue, nausea vomiting and reduced mobility. The main complaints of
pleural effusion are dyspnoea and cough. Paracentesis and thoracentesis provide relief for a
very limited period.
Studies have shown high concentrations of VEGF in malignant ascites and pleural effusion.
Beneficial effects of treatment with an intravenous or intraperitoneal antibody against VEGF
on malignant ascites have been reported. In the recent past we have treated two patients
with symptomatic malignant ascites (colorectal cancer and ovarian cancer, respectively) in a
phase I study with cediranib. Shortly after start of cediranib, within a couple of days, the
ascites disappeared. However, after stopping cediranib for progressive disease on other
sites the ascites reappeared within days. Therefore, one of those patients was treated with
cediranib as palliative treatment until two days before his death, which was beneficial for
In this phase II study we would like to investigate the effects of treatment with cediranib
as palliative treatment on malignant ascites or pleural effusion.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
puncture free survival
If the puncture free survival after start of treatment with cediranib (time to first need for paracentesis or thoracentesis or time to death, which event occurred first) is more than 44 days the treatment of ascites and/or pleural effusion with cediranib is effective.
C.M.L. van Herpen, Md PhD
University Medical Centre Nijmegen
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)