Cediranib as Palliative Treatment in Patients With Symptomatic Malignant Ascites or Pleural Effusion
In some patients with cancer there are also cancer cells in the abdominal cavity or between the lung membranes. These cancer cells create too much moisture in the abdominal cavity or between the lung membranes. If there is fluid in the abdominal cavity (ascites fluid) this can bring on abdominal distension, abdominal pain, loss of appetite, fatigue, bloating and sometimes wheezing. Too much fluid between the lung membranes (we call this pleural fluid) gives breathlessness, chest pain and coughing. The use of diuretics may offer a small group of patients symptom reduction. Additionally, the fluid can be drained through a needle puncture or fluid collection (through a biopsy). But usually, the moisture quickly returns.
Previous research done in this hospital with cediranib showed that with some patients with cancer who suffered from fluid in the abdominal cavity or between the lung membranes, this moisture reduces while using this drug. It also reduced the symptoms caused by this excessive moisture.
The current study is conducted to see whether patients with cancer and fluid in the abdominal cavity or fluid between the lung blades benefit from using cediranib. This involves not only whether the amount moisture reduces, but also if the complains decrease. In addition, we will carefully consider the possible side effects of cediranib.
|Malignant Ascites Malignant Pleural Effusion||Drug: immediate cediranib Drug: Start cediranib after 28 days Best Supportive Care||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Cediranib as Palliative Treatment in Patients With Symptomatic Malignant Ascites or Pleural Effusion|
- puncture free survival [ Time Frame: 44 days ]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.
|Study Start Date:||April 2010|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
Active Comparator: immediate treatment with cediranib
8 patients with ascites and 8 patients with pleural effusion will start immediate treatment with cediranib
Drug: immediate cediranib
cediranib 30 mg on day one; Special in this study is the possibility to decrease (to a minimum of 15 mg) or increase the dose (to a maximum of 30 mg oid) during the study to get an individualized optimal palliative treatment with cediranib. The patient will continue cediranib as long as a clinical benefit is experienced, independent of tumour evaluation. Each dose changes should be documented with clear reasoning and documentation of the approach taken
Other Name: AZD2171
Active Comparator: start cediranib after 28 days BSC
patients in group B will start with cediranib after one month best supportive care.
Drug: Start cediranib after 28 days Best Supportive Care
patients in this group will start with cediranib after one month best supportive care. Special in this study is the possibility to decrease (to a minimum of 15 mg) or increase the dose (to a maximum of 30 mg oid) during the study to get an individualized optimal palliative treatment with cediranib. The patient will continue cediranib as long as a clinical benefit is experienced, independent of tumour evaluation. Each dose changes should be documented with clear reasoning and documentation of the approach taken.
Other Name: AZD2171
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 this patient.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01262612
|University Medical Centre Nijmegen|
|Nijmegen, Gelderland, Netherlands, 6500 HB|
|Principal Investigator:||C.M.L. van Herpen, Md PhD||University Medical Centre Nijmegen|