Nintedanib in Treating Patients With Malignant Pleural Mesothelioma That Is Recurrent

Inclusion Criteria

• Patients must have histologically confirmed diagnosis of unresectable malignant pleural mesothelioma
• Patients must have measurable or non-measurable disease documented by computed tomography (CT) scan; measurable disease must be assessed within 28 days prior to registration; non-measurable disease must be assessed within 42 days prior to registration; the CT from a combined positron emission tomography (PET)/CT must not be used to document measurable disease unless it is of diagnostic quality; all disease must be assessed by RECIST and modified RECIST criteria
• Patients must have had prior systemically administered platinum-based chemotherapy; pleural space washing with cisplatin does not constitute systemic administration; no more than two prior systemic therapeutic regimens are allowed (including biologics, targeted and immunotherapies), and at least one regimen must have been platinum-based; neoadjuvant and/or adjuvant systemic therapy will not be counted as a prior regimen, assuming at least 12 weeks have elapsed between the end of neoadjuvant/adjuvant therapy and development of progressive disease; patients must have completed systemic therapy (including any chemotherapy, biologics, targeted and immunotherapies) >= 28 days (42 days for nitrosoureas or mitomycin C) prior to registration and have recovered from adverse events due to agents administered
• No prior treatment with BIBF 1120 or any other vascular endothelial growth factor receptor (VEGFR) inhibitor
• No known hypersensitivity to BIBF 1120, to its excipients or to contrast media
• Patients may have received prior surgery (e.g., pleurectomy) provided that at least 28 days have elapsed since surgery (thoracic or other major surgeries) and patients have recovered from all associated toxicities at the time of registration; there must be no anticipated need for major surgical procedures during protocol treatment
• No active brain metastases (e.g. stable for = 1,500/mcl
• Platelet count >= 100,000/mcl
• Serum bilirubin = 2.5 ULN
• Serum creatinine = = 50 mL/min using the following formula: calculated creatinine clearance = (140-age) x wt (weight) (kg) x 0.85 (if female)/72 x creatinine (mg/dl); these tests (including creatinine [mg/dl] if using calculated creatinine clearance) must be obtained within 14 days prior to registration
• No proteinuria Common Terminology Criteria For Adverse Events (CTCAE) grade 2 or greater
• No therapeutic anticoagulation (except low-dose heparin and/or heparin flush as needed for maintenance of an in-dwelling intravenous device) or anti-platelet therapy (except for low-dose therapy with acetylsalicylic acid NYHA [New York Heart Association Class] II, serious cardiac arrhythmia, pericardial effusion)
• No active serious infections in particular if requiring systemic antibiotic or antimicrobial therapy
• No active or chronic hepatitis C and/or B infection
• Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method
• No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years
• No psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow-up schedule
• No active alcohol or drug abuse
• All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines