Paclitaxel With or Without Viral Therapy in Treating Patients With Recurrent or Persistent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
This randomized phase II trial is studying 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. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Viral therapy may be able to kill tumor cells without damaging normal cells. Giving chemotherapy together with viral therapy may kill more tumor cells
Recurrent Fallopian Tube Cancer
Recurrent Ovarian Epithelial Cancer
Recurrent Primary Peritoneal Cavity Cancer
Biological: wild-type reovirus
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Progression-free survival (PFS) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
- Frequency and severity of adverse events as assessed by CTCAE v4.0 [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
- Median PFS by treatment group [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]The Cox proportional hazards ratio for patients with measurable disease to non-measurable disease, the Kaplan-Meier estimates of each population.
- Median overall survival (OS) by treatment group [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]The Cox proportional hazards ratio for patients with measurable disease to non-measurable disease, the Kaplan-Meier estimates of each population.
- Tumor response by RECIST and CA-125 criteria [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||December 2010|
|Estimated Primary Completion Date:||September 2019 (Final data collection date for primary outcome measure)|
Experimental: Arm I (paclitaxel)
Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15.
Experimental: Arm II (paclitaxel and wild-type reovirus)
Patients receive paclitaxel as in arm I and wild-type reovirus IV over 1 hour on days 1-5.
Biological: wild-type reovirus
Other Name: REOLYSINDrug: paclitaxel
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.
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.