A phase II study of cediranib as palliative treatment in patients with symptomatic malignant ascites or pleural effusio

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 32

Inclusion Criteria

-symptomatic malignant ascites and/or pleural effusion (from a histological proven solid malignancy which is refractory to standard anti-tumour therapy of for which no standard therapy exists)
-Karnofsky score = 50 % if the low performance score is due to ascites and/or pleural effusion, otherwise = 60 %
-age = 18 years
-written informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Contraindications for treatment with cediranib:
-the presence of a pleural or peritoneal tap
-Untreated unstable brain or meningeal metastases..
-Previous treatment with chemotherapeutic agents or tyrosine kinase inhibitors (TKIs) within 14 days prior to the first dose of cediranib, with cetuximab within 30 days prior to the first dose of cediranib, or with bevacizumab within 60 days prior to the first dose of cediranib
-Inadequate bone marrow reserve as demonstrated by an absolute neutrophil count =1.5 x 109/L or platelet count =100 x 109/L
-Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) = 2,5 x ULN
-Serum creatinine > 1.5 x ULRR or a creatinine clearance of = 50mL/min calculated by the MDRD equation
-Greater than +1 proteinuria on two consecutive dipsticks taken no less than 1 week apart unless urinary protein < 1.5g in a 24 hr period
-Prothrombin time (PT) and activated partial thromboplastin time (APTT) > 2 x ULN, History of significant gastrointestinal impairment, as judged by the Investigator, that would significantly affect the absorption of cediranib, including the ability to swallow the tablet whole. Patients with an ileostoma.
-Patients with a history of poorly controlled hypertension with resting blood pressure >150/100 in the presence or absence of a stable regimen of anti-hypertensive therapy. Patients who are currently receiving maximal doses of calcium channel blockers or more than 1 antihypertensive for the treatment of hypertension are also ineligible.
-Any evidence of severe or uncontrolled diseases e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease.
-Unresolved toxicity > CTC grade 1 from previous anti-cancer therapy (including radiotherapy) except alopecia (if applicable) or polyneuropathie.
-Mean QTc with Bazetts correction >470msec in screening ECG or history of familial long QT syndrome
-Significant haemorrhage (>30mL bleeding/episode in previous 3 months) or haemoptysis (>5mL fresh blood in previous 4 weeks)
-Recent (<14 days) major surgery prior to entry into the study, or a surgical incision that is not fully healed
-Pregnant or breast-feeding women or women of childbearing potential with a positive pregnancy test prior to receiving study medication
-Known risk of the patient transmitting HIV, hepatitis B or C via infected blood
-Treatment with an investigational (non-registered) drug within 30 days prior to the first dose of cediranib
-Other concomitant anti-cancer therapy (including LHRH agonists) except steroids
-Concomitant use of any medication that may significantly affect hepatic cytochrome P450 drug metabolising activity by way of enzyme induction (e.g., phenytoin) or inhibition (e.g., ketoconazole, ritonavir, erythromycin) within 2 weeks if the first dose of cediranib and throughout the study period
-Patients being treated with anticoagulants (with the exception of low molecular weight heparin).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess 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)<br>;Secondary Objective: 1. To assess the palliative effects of cediranib on ascites and ascites related symptoms or to assess the palliative effects of cediranib on pleural effusion and pleural effusion related symptoms.<br>2. to assess the effect of treating ascites and/or pleural effusion with cediranib on the quality of life<br>3. To asses the toxicity profile of cediranib (acute and late adverse events) in this group of patients<br>4. To assess the tumour response (CT scan)<br>5. To assess the overall survival<br><br><br><br>;Primary end point(s): 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.

Secondary Outcome Measures

Name	Time	Method

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