BIBF 1120 in Bevacizumab Resistant, Persistent, or Recurrent Epithelial Ovarian Cancer

Inclusion Criteria

• •Recurrent or persistent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma w/ histologic documentation of the original primary tumor via the pathology report:
• •* serious, endometrioid, mucinous, or clear cell adenocarcinoma
• •* undifferentiated, mixed epithelial or transitional cell carcinoma
• •* Brenner's Tumor
• •* adenocarcinoma NOS
• •Had treatment-free interval following response to bevacizumab (CR, PR, or SD) of \< 6 months, or have progressed during treatment w/ a bevacizumab-containing therapy
• •Measurable or detectable disease. Measurable is defined by RECIST 1.1. Each lesion must be ≥ 10 mm when measured by CT, MRI or caliper measurement by clinical exam; or ≥ 20 mm when measured by chest x-ray. Lymph nodes must be \> 15 mm in short axis when measured by CT or MRI. Detectable defined as no measurable disease but either ascities/pleural effusion or solid/cystic abnormalities that don't meet RECIST 1.1 - both within the setting of CA125 \>2xULN
• •Those with measurable disease must have at least one "target lesion" to assess response as defined by RECIST 1.1. Tumors in a previously irradiated field will be designated as "non-target" lesions
• •Must have a ECOG Performance Status of 0 or 1
• •Free of active infection requiring antibiotics. Exception: uncomplicated UTI
• •Recovery from effects of recent surgery, radiotherapy, or chemotherapy
• •* Hormonal therapy directed at the malignant tumor must be d/c at least a week prior to registration. Hormone replacement therapy is permitted
• •* Other prior therapy directed at malignant tumor, including immunologic agents, must be d/c at least 3 weeks prior to registration; 4 weeks if prior therapy was w/ bevacizumab
• •Prior therapy
• •* must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound. This initial treatment may have included intraperitoneal therapy, high-dose therapy, consolidation, non-cytotoxic agents or extended therapy administered after surgical or non-surgical assessment.
• •* Allowed, to receive, but not required to receive, 2 additional cytotoxic regimens for management of recurrent or persistent disease according to the following:
• •* Patients who have received only one prior cytotoxic regimen (platinum-based regimen for management of primary disease), must have a platinum-free interval of less than 12 months, or have progressed during platinum-based therapy, or have persistent disease after a platinum-based therapy.
• •* Patients must NOT have received any non-cytotoxic therapy for management of recurrent or persistent disease other than bevacizumab. Patients are allowed to receive, but are not required to receive, biologic (non-cytotoxic) therapy as part of their primary treatment regimen.
• •Must have adequate:
• •* Bone marrow function: Absolute neutrophil count (ANC) ≥ 1,500/mcl, equivalent to (CTCAE v4.0) grade 1. Platelets ≥ 100,000/mcl. Hemoglobin (Hb) ≥ 9.0 g/dL
• •* Renal function: creatinine ≤ 1.5 x upper limit of normal (ULN)
• •* Hepatic function: Bilirubin should be w/in normal limits (CTCAE v4.0, grade 1). ALT/AST, should be ≤ 1.5 x ULN (CTCAE v4.0, grade 1). For patients w/ liver metastases, ALT/AST should be ≤ 2.5 x ULN; Alkaline phosphatase should be ≤ 2.5 x ULN (CTCAE v4.0, grade 1)
• •* Neurologic function: Neuropathy ≤ CTCAE v4.0, grade 1
• •Blood coagulation parameters: PT w/ international normalized ratio (INR) \< 1.5 x ULN \& a PTT \< 1.5 x ULN (or an in-range PTT if on a stable dose of therapeutic heparin). Low molecular weight heparin (enoxaparin or alternative anticoagulants (other than warfarin)) are acceptable.
• •Signed informed consent \& authorization permitting release of personal health information
• •Negative serum pregnancy test if of childbearing potential prior to study entry \& use of effective form of contraception until 3 months after receiving last drug treatment
• •Patients may have undergone a major or minor surgical procedure as long as:
• •* \> 28 days prior to the first date of study therapy
• •* Core biopsy or IV Port placement greater than 7 days prior to the first date of study therapy