Paclitaxel With or Without Viral Therapy in Treating Patients With Recurrent or Persistent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
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|ClinicalTrials.gov Identifier: NCT01199263|
Recruitment Status : Completed
First Posted : September 10, 2010
Results First Posted : October 30, 2019
Last Update Posted : September 15, 2020
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Fallopian Tube Carcinoma Recurrent Ovarian Carcinoma Recurrent Primary Peritoneal Carcinoma||Other: Laboratory Biomarker Analysis Drug: Paclitaxel Biological: Pelareorep||Phase 2|
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).
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 (Clinical Trial)|
|Actual Enrollment :||108 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Phase II Evaluation of Weekly Paclitaxel (NSC# 673089) Versus Weekly Paclitaxel With Oncolytic Reovirus (Reolysin NSC # 729968) in the Treatment of Recurrent or Persistent Ovarian, Fallopian Tube or Primary Peritoneal Cancer|
|Actual Study Start Date :||December 6, 2010|
|Actual Primary Completion Date :||June 1, 2015|
|Actual Study Completion Date :||July 17, 2020|
Experimental: Arm I (paclitaxel)
Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15.
Other: Laboratory Biomarker Analysis
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.
Other: Laboratory Biomarker Analysis
- Progression-free Survival (PFS) [ Time Frame: Approximately 4.5 years. ]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
- Number of Participants With Adverse Events Grade 3 or Greater as Assessed by CTCAE Version 4.0 [ Time Frame: approximately 4.5 years ]The frequency and severity of Grade 3 and above toxicities are tabulated.
- Percentage of Participants withTumor Response by RECIST [ Time Frame: approximately 4.5 years ]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
- Median Overall Survival (OS) by Treatment Group [ Time Frame: After patient stops protocol therapy, she is followed quarterly for 2 years, semi-annually for 3 more years, approximately 4.5 years. ]Time from patient randomization to death or date last seen.
- Tumor Response by CA125 [ Time Frame: Before every cycle, approximately 4.5 years. ]Percentage of participants with Complete and Partial Tumor Response by CA125.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01199263
|Principal Investigator:||David E Cohn||NRG Oncology|