Rilotumumab in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
Condition: Recurrent Fallopian Tube Carcinoma; Recurrent Ovarian Carcinoma; Recurrent Primary Peritoneal Carcinoma
MeSH terms: Carcinoma; Recurrence
Intervention: Laboratory Biomarker Analysis; Rilotumumab
Intervention description: Correlative studies; Given IV
Intervention MeSH terms: Antineoplastic Agents, Immunological; Rilotumumab; Antibodies; Immunoglobulins; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well rilotumumab works in treating patients with ovarian
      epithelial, fallopian tube, or primary peritoneal cancer that has failed to respond to other
      therapies (persistent) or has returned after a period of improvement (recurrent). Rilotumumab
      is a type of drug called a monoclonal antibody, and may interfere with the ability of tumor
      cells to grow and spread by targeting certain cells and blocking them from working.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have recurrent or persistent epithelial ovarian, fallopian tube, or
             primary peritoneal carcinoma; histologic confirmation of the original primary tumor is
             required via the pathology report

          -  All patients must have measurable disease as defined by Response Evaluation Criteria
             in Solid Tumors (RECIST) 1.1; measurable disease is defined as at least one lesion
             that can be accurately measured in at least one dimension (longest diameter to be
             recorded); each lesion must be >= 10 mm when measured by computed tomography (CT),
             magnetic resonance imaging (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

          -  Patient must have at least one "target lesion" to be used to assess response on this
             protocol as defined by RECIST 1.1; tumors within a previously irradiated field will be
             designated as "non-target" lesions unless progression is documented or a biopsy is
             obtained to confirm persistence at least 90 days following completion of radiation
             therapy

          -  Patients must not be eligible for a higher priority Gynecologic Oncology Group (GOG)
             protocol, if one exists; in general, this would refer to any active GOG Phase III
             protocol for the same patient population

          -  Patients who have received one prior regimen must have a GOG performance status of 0,
             1, or 2

               -  Patients who have received two prior regimens must have a GOG performance status
                  of 0 or 1

          -  Recovery from effects of recent surgery, radiotherapy, or chemotherapy

          -  Major surgical procedures must have taken place > 30 days before enrollment; minor
             surgical procedures must have taken place > 14 days before enrollment; central venous
             catheter placement is allowed at any time prior to enrollment provided the patient has
             recovered and any surgical would has healed

          -  Patients should be free of active infection requiring antibiotics (with the exception
             of uncomplicated urinary tract infections [UTI])

          -  Any hormonal therapy directed at the malignant tumor must be discontinued at least one
             week prior to registration

          -  Any other prior therapy directed at the malignant tumor, including immunologic agents,
             must be discontinued at least three weeks prior to registration

          -  Patients 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

          -  Patients are allowed to receive, but are not required to receive, one additional
             cytotoxic regimen for management of recurrent or persistent disease according to the
             following definition:

               -  Cytotoxic regimens include any agent that targets the genetic and/or mitotic
                  apparatus of dividing cells, resulting in dose-limiting toxicity to the bone
                  marrow and/or gastrointestinal mucosa

                    -  Note: Patients on this non-cytotoxic study are allowed to have received
                       prior cytotoxic chemotherapy for management of recurrent or persistent
                       disease, as defined above; however, patients are encouraged to enroll on
                       second-line non-cytotoxic studies prior to receiving additional cytotoxic
                       therapy

          -  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; patients are allowed to receive, but are not required to
             receive, biologic (non-cytotoxic) therapy as part of their primary treatment regimen

          -  Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl

          -  Platelets greater than or equal to 100,000/mcl

          -  Hemoglobin >= 9 g/dL

          -  Creatinine less than or equal to 1.5 x institutional upper limit normal (ULN)

          -  Bilirubin less than or equal to 1.5 x ULN

          -  Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) less
             than or equal to 3 x ULN

          -  Alkaline phosphatase less than or equal to 2.5 x ULN

          -  PTT (partial thromboplastin time) =< 1.5 x ULN

          -  International normalized ratio (INR) =< 1.5 x ULN

          -  Neuropathy (sensory and motor) less than or equal to CTCAE grade 1

          -  Proteinuria: =< 1+ (urinalysis) or < 1 g/24 hrs (24 hour urine collection)

          -  Patients must have signed an approved informed consent and authorization permitting
             release of personal health information

          -  Patients must meet pre-entry requirements

          -  Patients of childbearing potential must have a negative serum pregnancy test prior to
             the study entry and be practicing an effective form of contraception

        Exclusion Criteria:

          -  Patients who have had previous treatment with AMG 102 (rilotumumab) or other
             hepatocyte growth factor (HGF)/MET proto-oncogene, receptor tyrosine kinase (c-met)
             pathway inhibitors

          -  Patients with a history of other invasive malignancies, with the exception of
             non-melanoma skin cancer and other specific malignancies as noted, are excluded if
             there is any evidence of other malignancy being present within the last three years;
             patients are also excluded if their previous cancer treatment contraindicates this
             protocol therapy

          -  Patients who have received prior radiotherapy to any portion of the abdominal cavity
             or pelvis OTHER THAN for the treatment of ovarian, fallopian tube, or primary
             peritoneal cancer within the last three years are excluded; prior radiation for
             localized cancer of the breast, head and neck, or skin is permitted, provided that it
             was completed more than three years prior to registration, and the patient remains
             free of recurrent or metastatic disease

          -  Patients who have received prior chemotherapy for any abdominal or pelvic tumor OTHER
             THAN for the treatment of ovarian, fallopian tube, or primary peritoneal cancer within
             the last three years are excluded; patients may have received prior adjuvant
             chemotherapy for localized breast cancer, provided that it was completed more than
             three years prior to registration, and that the patient remains free of recurrent or
             metastatic disease

          -  Patients with a past history of primary endometrial cancer are excluded unless all of
             the following conditions are met: stage not greater than I-B; no more than superficial
             myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated
             subtypes, including papillary serous, clear cell or other International Federation of
             Gynecology and Obstetrics (FIGO) grade 3 lesions

          -  Patients with an active bleeding diathesis or on concurrent or prior (within 7 days of
             enrollment) therapeutic anti-coagulation therapy with warfarin, heparin, or low
             molecular weight heparin; the use of low-dose warfarin (=< 2 mg orally [PO] daily) for
             prophylaxis against central venous catheter thrombosis is allowed

          -  Patients with serious intercurrent infections or nonmalignant medical illnesses that
             are uncontrolled or whose control may be jeopardized by this treatment

          -  Patients who are pregnant or breastfeeding

          -  Patients with psychiatric or other conditions rendering them incapable of
             participating in informed consent or the requirements of this protocol

          -  Patients with a serious or non-healing wound

          -  Patients with peripheral edema or lymphedema > grade 2

          -  Patients with known positive human immunodeficiency virus (HIV) or hepatitis C or
             chronic or active hepatitis B

          -  Patients with thromboembolic event or ischemic event within the past 12 months, such
             as deep venous thrombosis, pulmonary embolism, transient ischemic attack, cerebral
             infarction, or myocardial infarction