A Randomized Phase II Evaluation of Weekly Paclitaxel (NSC# 673089) Versus Weekly Paclitaxel With Oncolytic Reovirus (Reolysin® NSC # 729968, BB-IND # 13370) in the Treatment of Recurrent or Persistent Ovarian, 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