Paclitaxel With or Without Viral Therapy in Treating Patients With Recurrent or Persistent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
Condition: Recurrent Fallopian Tube Carcinoma; Recurrent Ovarian Carcinoma; Recurrent Primary Peritoneal Carcinoma
MeSH terms: Carcinoma; Recurrence
Intervention: Laboratory Biomarker Analysis; Paclitaxel; Pelareorep
Intervention description: Correlative studies; Given IV; Given IV
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 108.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized phase II trial studies the side effects and how well giving paclitaxel with
      or without viral therapy works in treating patients with ovarian epithelial, fallopian tube,
      or primary peritoneal cancer that has come back. Drugs used in chemotherapy, such as
      paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the
      cells, by stopping them from dividing, or by stopping them spreading. Viral therapy may be
      able to kill tumor cells without damaging normal cells. Giving paclitaxel together with viral
      therapy may kill more tumor cells.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have recurrent or persistent epithelial ovarian, fallopian tube or
             primary peritoneal carcinoma; histologic documentation of the original primary tumor
             is required via the pathology report

          -  Patients must have measurable disease or detectable (non-measurable) disease:

               -  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

               -  Detectable (non-measurable) disease is defined as not having measurable disease
                  but has at least one of the following conditions:

                    -  Baseline values of CA-125 at least 2 x upper limit of normal (ULN);

                    -  Ascites and/or pleural effusion attributed to tumor;

                    -  Solid and/or cystic abnormalities on radiographic imaging that do not meet
                       RECIST 1.1 definitions for target lesions

          -  Patient with measurable disease 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 or rare tumor 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 or three prior regimens must have a GOG
                  performance status of 0 or 1

          -  Recovery from effects of recent surgery, radiotherapy, or chemotherapy:

               -  Patients should be free of active infection requiring antibiotics (with the
                  exception of uncomplicated urinary tract infection [UTI])

               -  Any hormonal therapy directed at the malignant tumor must be discontinued at
                  least one week prior to registration; continuation of hormone replacement therapy
                  is permitted

               -  Any other prior therapy directed at the malignant tumor, including chemotherapy,
                  biologic/targeted and 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, consolidation, non-cytotoxic agents (biologic/targeted) or extended therapy
             administered after surgical or non-surgical assessment; if patients were treated with
             paclitaxel for their primary disease, this can have been given weekly or every 3 weeks

          -  Patients are allowed to receive, but are not required to receive, two additional
             cytotoxic regimens for management of recurrent or persistent disease, with no more
             than 1 non-platinum, non-taxane regimen; treatment with weekly paclitaxel for
             recurrent or persistent disease is NOT allowed

          -  Patients are allowed to receive, but are not required to receive, non-cytotoxic
             (biologic/targeted) therapy as part of their primary treatment regimen; patients are
             allowed to receive, but are not required to receive, non-cytotoxic (biologic/targeted)
             therapy as part of their treatment for recurrent or persistent disease and/or as
             treatment for recurrent or persistent disease; if non-cytotoxic (biologic/targeted)
             therapy is given alone (i.e., not in combination with cytotoxic chemotherapy) it will
             NOT count as a prior regimen

               -  For the purposes of this study, poly (adenosine diphosphate [ADP]-ribose)
                  polymerase (PARP) inhibitors will NOT count as a prior regimen when given alone
                  (i.e., not in combination with cytotoxic chemotherapy)

          -  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

          -  Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl

          -  Platelets greater than or equal to 100,000/mcl

          -  Hemoglobin greater than or equal to 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) less than or equal to 3 x ULN

          -  Alkaline phosphatase less than or equal to 2.5 x ULN

          -  Neuropathy (sensory and motor) less than or equal to grade 1

          -  Patients of childbearing potential must have a negative pregnancy test prior to the
             study entry and be practicing an effective form of contraception; (pregnant women are
             excluded from this study)

          -  Patients must have signed an approved informed consent and authorization permitting
             the release of personal health information

          -  Patients must meet pre-entry requirements as specified

          -  Patients must be able to avoid direct contact with severely immune-compromised
             individuals such as patients who have had a recent bone-marrow or organ transplant or
             patients with acquire immunodeficiency syndrome (AIDS); contact should be avoided on
             the days of Reolysin treatment and for the 2 days following Reolysin treatment

          -  Patients must be able to avoid direct contact with pregnant or nursing women and
             infants while receiving Reolysin; contact should be avoided on the days of Reolysin
             treatment and for the 2 days following Reolysin treatment

        Exclusion Criteria:

          -  Patient who have had previous treatment with Reolysin or other oncolytic virus;
             patients who have had previous treatment with weekly paclitaxel for recurrent or
             persistent disease

          -  Patients with a history of other invasive malignancies, with the exception of
             non-melanoma skin cancer and other specific malignancies 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 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 serious, clear cell or other International Federation of
             Gynecology and Obstetrics (FIGO) grade 3 lesions

          -  Patients with known human immunodeficiency virus (HIV) or hepatitis B or C are
             excluded due to risk of viral infectivity of Reolysin therefore patients with a
             pre-existent infection are not eligible

          -  Patients who are receiving immunosuppressive therapy including chronic oral steroids
             (at an equivalent dose of greater than prednisone 5 mg daily)

          -  Women who are pregnant or nursing; pregnant women are excluded from this study;
             breastfeeding should be discontinued while the mother is being treated with the agents
             in this clinical trial

          -  Myocardial infarction or unstable angina within 6 months of the first date of study
             therapy

          -  History of serious ventricular arrhythmia (i.e., ventricular tachycardia or
             ventricular fibrillation) or cardiac arrhythmias requiring anti-arrhythmic medications
             (except for atrial fibrillation that is well controlled with antiarrhythmic
             medication)

          -  Troponin > ULN

          -  Baseline ejection fraction < 50% as assessed by echocardiogram or multi gated
             acquisition scan (MUGA)

          -  New York Heart Association (NYHA) class II or greater congestive heart failure

          -  History of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or
             subarachnoid hemorrhage within six months of the first date of study therapy