Phase II Evaluation of BIBF 1120 in the Treatment of Bevacizumab-Resistant, Persistent, or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma
The main purpose of this study is to see if BIBF 1120 can increase the number of women with bevacizumab resistant, persistent, or recurrent epithelial ovarian cancer who do not progress for at least six months.
• 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