PeRsOnalized treatment fOr patients with pleural eFfusions due to malignant pleural mesothelioma or lung cancer in second or third line. An open label phase II study (Acronym: the PROOF study)

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: Stichting Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis
Status: Active, not recruiting
Last Updated: 11 years ago

No summary available.

Registry

who.int

Start Date

June 11, 2014

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Patients with histologically or cytologically proven pleural effusion of
•malignant mesothelioma or non small cell lung cancer
•Age \>18 years.
•At the date of randomization, the patients must have completed:
•For MPM: first\-line chemotherapy with platinum (cisplatin or carboplatin) and pemetrexed combination with evidence of progressive disease.
•For NSCLC: first and second line therapy according to the local guide lines with evidence of progressive disease.
•Measurable or evaluable disease.
•Ability to understand the study and give signed informed consent prior to beginning of protocol specific procedures.
•WHO performance status \= 2
•Adequate organ function as evidenced by the following peripheral blood counts or serum chemistries at study entry:

•Active uncontrolled infection, severe cardiac dysfunction or non\-correctable bleeding tendency.
•Any identification of a driver mutation for which a registered treatment is available
•Presence of symptomatic CNS metastases.
•Radiotherapy within 2 weeks prior to study entry.
•Unstable peptic ulcer, unstable diabetes mellitus or other serious disabling condition.
•Concomitant administration of any other experimental drugs under investigation.
•Any non\-resolved grade 3 or higher toxicity.
•For neurotoxicity any non\-resolved grade 2 or higher toxicity