CONTINUOUS TREATMENT WITH SUNITINIB IN PATIENTS WITH SYMPTOMATIC PLEURAL AND/OR PERITONEAL MALIGNANT EFFUSIONS. - SUPPER

• Conditions: Symtomatic malignant pleural and/ or peritoneal effusions regardless of the primary tumor site or histological charestistics

• Registration Number: EUCTR2007-006459-38-BE
• Lead Sponsor: St Augustinus

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08-05
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1.Histopathologically confirmed malignancy.
2.Histologically or cytopathologically confirmed malignant pleural and/or peritoneal effusions. If both are present in any one patient, malignancy most be documented in at least one site.
3.Radiologically documented increase in pleural and/or peritoneal fluid over the past 6 weeks prior to enrollment into this study.
4.Disease extent is not amenable to standard therapy with curative intent,
5.Have refractory disease or a disease state were systemic options are either non-existant, considered not feasible or not justified, or refused.
6.Male or female, 18 years of age or older.
7.Resolution of all acute toxic effects of prior systemic therapy, radiotherapy or surgical procedure to NCI CTCAE Version 3.0 grade =1. Prior therapy with taxanes is allowed, but last administration must have dated at least 6 weeks prior to enrollment in this study.
8.Adequate organ function as defined by the following criteria:
.• Total serum bilirubin =2 x ULN
.• Serum transaminases <5 x ULN
.• Serum creatinine =2 x ULN
.• Absolute neutrophil count (ANC) =1000/mL without G-CSF)
.• Platelets =75,000/mL
.• Hemoglobin =8.0 g/dL
9.Signed and dated informed consent document indicating that the patient has been informed of all the pertinent aspects of the trial prior to enrollment.
10.Willingness and ability to comply with scheduled visits & study procedures.

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

1.Current treatment in another therapeutic clinical trial.
2.Congestive heart failure, myocardial infarction or coronary artery bypass graft in the previous six months, ongoing severe or unstable angina or any unstable arrhythmia requiring medication.
3.Previous treatment with any anti-VEGF or anti-PDGF agent, or any other TKI.
4.Pregnancy or breastfeeding. Patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the principal investigator. Male patients must be surgically sterile or agree to use effective contraception.
5.Normal gastro-intestinal function, excluding patient subobstruction.
6.Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
7.Patients for whom obvious other treatment modalities for the underlying malignancy exist.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to evaluate the activity of sunitinib in patients with symptomatic malignant pleural and/or peritoneal effusions regardless of the primary tumor site or its histology.;Secondary Objective: The secondary aims are : <br>- Antitumor activity of Sunitinib <br>-Safety profile of Sunitinib <br>-Intrapleural PK of Sunitinib <br>-Translational studies of target inhibition <br>-Time to treatment failure (TTF)<br>;Primary end point(s): The primary endpoint for all patients is the frequency of non-progression at six weeks of continuous treatment. Non-progression is defined in 7.1. and includes patients of both strata and includes the absence of any need for a fluid evacuation procedure.