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
PRIMARY OBJECTIVES:
I. To estimate the progression-free survival (PFS) hazard ratio of the combination of weekly
paclitaxel with vs without wild-type reovirus 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 these regimens
as assessed by CTCAE v4.0.
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 RECIST 1.1 with measurable patients and by CA-125 for those
patients with detectible 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: This is a multicenter study. Patients are stratified according to their
platinum-free interval (=< 182 days vs > 182 days) and measurable disease status (measurable
vs non-measurable or detectable). Patients are randomized to 1 of 2 treatment arms
ARM I: Patients receive paclitaxel 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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival (PFS)
Up to 5 years
No
David Cohn
Principal Investigator
Gynecologic Oncology Group
United States: Food and Drug Administration
NCI-2011-02654
NCT01199263
December 2010
Name | Location |
---|---|
Mayo Clinic | Rochester, Minnesota 55905 |
University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
Hurley Medical Center | Flint, Michigan 48503 |
University of Oklahoma Health Sciences Center | Oklahoma City, Oklahoma 73104 |
University of New Mexico Cancer Center | Albuquerque, New Mexico 87131-5636 |
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Columbus, Ohio 43210-1240 |
Saint Joseph Mercy Hospital | Ann Arbor, Michigan 48106 |
Northeast Georgia Medical Center | Gainesville, Georgia 30501 |
Genesys Regional Medical Center | Grand Blanc, Michigan 48439-8066 |
Saint Alphonsus Regional Medical Center | Boise, Idaho 83706 |
Case Western Reserve University | Cleveland, Ohio 44106 |
Indiana University Medical Center | Indianapolis, Indiana 46202 |
Providence Saint Joseph Medical Center | Burbank, California 91505-4866 |
Saint Francis Hospital and Medical Center | Hartford, Connecticut 06105 |
Michigan Cancer Research Consortium Community Clinical Oncology Program | Ann Arbor, Michigan 48106 |
Oakwood Hospital | Dearborn, Michigan 48123 |
Saint John Hospital and Medical Center | Detroit, Michigan 48236 |
Allegiance Health | Jackson, Michigan 49201 |
Sparrow Hospital | Lansing, Michigan 48912 |
Saint Mary Mercy Hospital | Livonia, Michigan 48154 |
Saint Joseph Mercy Oakland | Pontiac, Michigan 48341-2985 |
Saint Joseph Mercy Port Huron | Port Huron, Michigan 48060 |
Saint Mary's of Michigan | Saginaw, Michigan 48601 |
Saint John Macomb-Oakland Hospital | Warren, Michigan 48093 |
Lake University Ireland Cancer Center | Mentor, Ohio 44060 |
Carilion Clinic Gynecological Oncology | Roanoke, Virginia 24016 |
Women's Cancer Center of Nevada | Las Vegas, Nevada 89109 |
Palo Alto Medical Foundation-Gynecologic Oncology | Mountain View, California 94040 |