Paclitaxel With or Without Viral Therapy in Treating Patients With Recurrent or Persistent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer

Inclusion Criteria:

• Histologically confirmed diagnosis of ovarian epithelial, fallopian tube, or primary peritoneal cancer

  • Recurrent or persistent disease

• Measurable or detectable (non-measurable) disease

  • Measurable disease is defined as ≥ 1 lesion that can be accurately measured in 1 dimension (longest diameter to be recorded) as ≥ 10 mm by CT scan, MRI, or caliper measurement by clinical exam or as ≥ 20 mm when measured by chest x-ray; lymph nodes must be ≥ 15 mm in short axis when measured by CT scan or MRI

    • Patients with measurable disease must have ≥ 1 "target lesion" to be used to assess response to study treatment as defined by RECIST 1.1 (tumors within a previously irradiated field will be designated as "non-target" lesion unless progression is documented or a biopsy is obtained to confirm persistence ≥ 90 days after completion of radiotherapy)

  • Detectable disease is defined as not having measurable disease, but having ≥ 1 of the following conditions:

    • Baseline values of CA-125 ≥ 2 times 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
• Not eligible for a higher priority GOG study, if one exists (in general, this would refer to any active GOG phase III protocol or Rare Tumor protocol for the same patient population)

• Received 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, the paclitaxel may have been administered weekly or every 3 weeks
• GOG performance status (PS) 0-2 (for patients who have received one prior regimen) OR GOG PS 0-1 (for patients who have received two or three prior regimens)
• ANC ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3
• Hemoglobin ≥ 9 g/dL
• Creatinine ≤ 1.5 times ULN
• Bilirubin ≤ 1.5 times ULN
• SGOT ≤ 3 times ULN
• Alkaline phosphatase ≤ 2.5 times ULN
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• 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 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
• Sensory and motor neuropathy ≤ grade 1

• No clinically significant cardiovascular disease, including any of the following:

  • Myocardial infarction or unstable angina within the past 6 months
  • History of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation) or cardiac arrhythmias requiring antiarrhythmic mediations (except for atrial fibrillation that is well controlled with antiarrhythmic medication)
  • Troponin I > ULN
  • Baseline ejection fraction ≤ 50% as assessed by ECHO or MUGA
  • NYHA class II-IV congestive heart failure
  • History of cerebrovascular accident, transient ischemic attack, or subarachnoid hemorrhage within the past 6 months
• No history of other invasive malignancies within the past 3 years except for nonmelanoma skin cancer

• No history of primary endometrial cancer unless all of the following criteria are met:

  • Stage not greater than IB
  • No more than superficial myometrial invasion without vascular or lymphatic invasion
  • No poorly differentiated subtypes, including papillary serous, clear cell, or other FIGO grade 3 lesions
• No known HIV or hepatitis B or C
• No active infection requiring antibiotics (except for uncomplicated urinary tract infection)
• No concurrent acetaminophen (if receiving wild-type reovirus)
• No prior wild-type reovirus or other oncolytic virus
• No prior cancer treatment that contraindicates study treatment

• Two additional cytotoxic regimens for management of recurrent or persistent disease allowed, with ≤ 1 non-platinum, non-taxane regimen

  • No prior weekly paclitaxel for recurrent or persistent disease

• Biologic/targeted (non-cytotoxic) therapy as part of the primary treatment regimen or as part of treatment for recurrent or persistent disease allowed

  • Prior non-cytotoxic therapy alone not counted as prior regimen
  • No prior non-cytotoxic therapy for recurrent or persistent disease

• Patients who have received only one prior cytotoxic regimen (platinum-based regimen for management of primary disease) must meet one of the following criteria:

  • Platinum-free interval of < 12 months
  • Progressed during platinum-based therapy
  • Have persistent disease after a platinum-based therapy
• Recovered from effects of recent surgery, radiotherapy, or chemotherapy

• No 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 past 3 years

  • Prior radiotherapy for localized cancer of the breast, head and neck, or skin is allowed provided that it was completed > 3 years ago and that the patient remains free of recurrent or metastatic disease

• No prior chemotherapy for any abdominal or pelvic tumor OTHER THAN for the treatment of ovarian, fallopian tube, or primary peritoneal cancer within the past 3 years

  • Prior adjuvant chemotherapy for localized breast cancer is allowed provided that it was completed > 3 years ago and that the patient remains free of recurrent or metastatic disease
• At least 3 weeks since prior therapy directed at the malignant tumor, including chemotherapy, biologic/targeted and immunologic agents

• At least 1 week since prior hormonal therapy directed at the malignant tumor

  • Concurrent hormone replacement therapy allowed
• No concurrent immunosuppressive therapy, including chronic oral steroids (at an equivalent dose of > 5 mg/day of prednisone)
• No other concurrent investigational therapy, immunotherapy, or chemotherapy