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.
PRIMARY OBJECTIVES: I. To estimate the progression-free survival hazard ratio of the combination of weekly paclitaxel with Reolysin (wild-type reovirus) to weekly paclitaxel alone in patients with persistent or recurrent ovarian, fallopian tube, or primary peritoneal cancer. II. To determine the frequency and severity of adverse events associated with treatment with weekly paclitaxel alone and weekly paclitaxel with REOLYSIN as assessed by Common Terminology Criteria for Adverse Events (CTCAE). SECONDARY OBJECTIVES: I. To estimate the progression-free survival and overall survival of patients treated with weekly paclitaxel alone and weekly paclitaxel with REOLYSIN. II. To estimate (and compare) the proportion of patients who respond to the regimen on each arm of the study (according to Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1 with measurable patients and by cancer antigen \[CA\]-125 for those patients with detectable disease only). III. To characterize and compare progression-free survival and overall survival in patients with measurable disease (RECIST 1.1 criteria) and patients with detectable (non-measurable) disease. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive paclitaxel intravenously (IV) over 1 hour on days 1, 8, and 15. ARM II: Patients receive paclitaxel as in arm I and wild-type reovirus IV over 1 hour on days 1-5. In both arms, treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
108
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, United States
Palo Alto Medical Foundation-Gynecologic Oncology
Mountain View, California, United States
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, United States
Northeast Georgia Medical Center-Gainesville
Gainesville, Georgia, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, United States
Progression-free Survival (PFS)
Time from patient entry until progression, death, or date last seen. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Time frame: Approximately 4.5 years.
Number of Participants With Adverse Events Grade 3 or Greater as Assessed by CTCAE Version 4.0
The frequency and severity of Grade 3 and above toxicities are tabulated.
Time frame: approximately 4.5 years
Percentage of Participants withTumor Response by RECIST
Participants with Complete and Partial Tumor Response by RECIST. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Time frame: approximately 4.5 years
Median Overall Survival (OS) by Treatment Group
Time from patient randomization to death or date last seen.
Time frame: After patient stops protocol therapy, she is followed quarterly for 2 years, semi-annually for 3 more years, approximately 4.5 years.
Tumor Response by CA125
Percentage of participants with Complete and Partial Tumor Response by CA125.
Time frame: Before every cycle, approximately 4.5 years.
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Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
Michigan Cancer Research Consortium NCORP
Ann Arbor, Michigan, United States
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States
Beaumont Hospital - Dearborn
Dearborn, Michigan, United States
Ascension Saint John Hospital
Detroit, Michigan, United States
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