Brief Title
Paclitaxel With or Without Viral Therapy in Treating Patients With Recurrent or Persistent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
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
Brief Summary
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.
Detailed Description
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 Phase
Phase 2
Study Type
Interventional
Primary Outcome
Progression-free Survival (PFS)
Secondary Outcome
Percentage of Participants withTumor Response by RECIST
Condition
Recurrent Fallopian Tube Carcinoma
Intervention
Laboratory Biomarker Analysis
Study Arms / Comparison Groups
Arm I (paclitaxel)
Description: Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
108
Start Date
December 6, 2010
Completion Date
July 17, 2020
Primary Completion Date
June 1, 2015
Eligibility Criteria
Inclusion Criteria:
- Patients must have recurrent or persistent epithelial ovarian, fallopian tube or
primary peritoneal carcinoma; histologic documentation of the original primary tumor
is required via the pathology report
- Patients must have measurable disease or detectable (non-measurable) disease:
- Measurable disease is defined as at least one lesion that can be accurately
measured in at least one dimension (longest diameter to be recorded); each lesion
must be >= 10 mm when measured by computed tomography [CT], magnetic resonance
imaging [MRI] or caliper measurement by clinical exam; or >= 20 mm when measured
by chest x-ray; lymph nodes must be > 15 mm in short axis when measured by CT or
MRI
- Detectable (non-measurable) disease is defined as not having measurable disease
but has at least one of the following conditions:
- Baseline values of CA-125 at least 2 x 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
- Patient with measurable disease must have at least one "target lesion" to be used to
assess response on this protocol as defined by RECIST 1.1; tumors within a previously
irradiated field will be designated as "non-target" lesions unless progression is
documented or a biopsy is obtained to confirm persistence at least 90 days following
completion of radiation therapy
- Patients must not be eligible for a higher priority Gynecologic Oncology Group (GOG)
protocol, if one exists; in general, this would refer to any active GOG phase III
protocol or rare tumor protocol for the same patient population
- Patients who have received one prior regimen must have a GOG performance status of 0,
1, or 2
- Patients who have received two or three prior regimens must have a GOG
performance status of 0 or 1
- Recovery from effects of recent surgery, radiotherapy, or chemotherapy:
- Patients should be free of active infection requiring antibiotics (with the
exception of uncomplicated urinary tract infection [UTI])
- Any hormonal therapy directed at the malignant tumor must be discontinued at
least one week prior to registration; continuation of hormone replacement therapy
is permitted
- Any other prior therapy directed at the malignant tumor, including chemotherapy,
biologic/targeted and immunologic agents, must be discontinued at least three
weeks prior to registration
- Patients must have had 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, this can have been given weekly or every 3 weeks
- Patients are allowed to receive, but are not required to receive, two additional
cytotoxic regimens for management of recurrent or persistent disease, with no more
than 1 non-platinum, non-taxane regimen; treatment with weekly paclitaxel for
recurrent or persistent disease is NOT allowed
- Patients are allowed to receive, but are not required to receive, non-cytotoxic
(biologic/targeted) therapy as part of their primary treatment regimen; patients are
allowed to receive, but are not required to receive, non-cytotoxic (biologic/targeted)
therapy as part of their treatment for recurrent or persistent disease and/or as
treatment for recurrent or persistent disease; if non-cytotoxic (biologic/targeted)
therapy is given alone (i.e., not in combination with cytotoxic chemotherapy) it will
NOT count as a prior regimen
- For the purposes of this study, poly (adenosine diphosphate [ADP]-ribose)
polymerase (PARP) inhibitors will NOT count as a prior regimen when given alone
(i.e., not in combination with cytotoxic chemotherapy)
- Patients who have received only one prior cytotoxic regimen (platinum-based regimen
for management of primary disease), must have a platinum-free interval of less than 12
months, or have progressed during platinum-based therapy, or have persistent disease
after a platinum-based therapy
- Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl
- Platelets greater than or equal to 100,000/mcl
- Hemoglobin greater than or equal to 9 g/dL
- Creatinine less than or equal to 1.5 x institutional upper limit normal (ULN)
- Bilirubin less than or equal to 1.5 x ULN
- Serum glutamic oxaloacetic transaminase (SGOT) less than or equal to 3 x ULN
- Alkaline phosphatase less than or equal to 2.5 x ULN
- Neuropathy (sensory and motor) less than or equal to grade 1
- Patients of childbearing potential must have a negative pregnancy test prior to the
study entry and be practicing an effective form of contraception; (pregnant women are
excluded from this study)
- Patients must have signed an approved informed consent and authorization permitting
the release of personal health information
- Patients must meet pre-entry requirements as specified
- 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 acquire immunodeficiency syndrome (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
Exclusion Criteria:
- Patient who have had previous treatment with Reolysin or other oncolytic virus;
patients who have had previous treatment with weekly paclitaxel for recurrent or
persistent disease
- Patients with a history of other invasive malignancies, with the exception of
non-melanoma skin cancer and other specific malignancies are excluded if there is any
evidence of other malignancy being present within the last three years; patients are
also excluded if their previous cancer treatment contraindicates this protocol therapy
- Patients who have received 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 last three years are excluded; prior radiation for
localized cancer of the breast, head and neck, or skin is permitted, provided that it
was completed more than three years prior to registration, and the patient remains
free of recurrent or metastatic disease
- Patients who have received prior chemotherapy for any abdominal or pelvic tumor OTHER
THAN for the treatment of ovarian, fallopian tube, or primary peritoneal cancer within
the last three years are excluded; patients may have received prior adjuvant
chemotherapy for localized breast cancer, provided that it was completed more than
three years prior to registration, and the patient remains free of recurrent or
metastatic disease
- Patients with a past history of primary endometrial cancer are excluded unless all of
the following conditions are met: stage not greater than I-B; no more than superficial
myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated
subtypes, including papillary serious, clear cell or other International Federation of
Gynecology and Obstetrics (FIGO) grade 3 lesions
- Patients with known human immunodeficiency virus (HIV) or hepatitis B or C are
excluded due to risk of viral infectivity of Reolysin therefore patients with a
pre-existent infection are not eligible
- Patients who are receiving immunosuppressive therapy including chronic oral steroids
(at an equivalent dose of greater than prednisone 5 mg daily)
- Women who are pregnant or nursing; pregnant women are excluded from this study;
breastfeeding should be discontinued while the mother is being treated with the agents
in this clinical trial
- Myocardial infarction or unstable angina within 6 months of the first date of study
therapy
- History of serious ventricular arrhythmia (i.e., ventricular tachycardia or
ventricular fibrillation) or cardiac arrhythmias requiring anti-arrhythmic medications
(except for atrial fibrillation that is well controlled with antiarrhythmic
medication)
- Troponin > ULN
- Baseline ejection fraction < 50% as assessed by echocardiogram or multi gated
acquisition scan (MUGA)
- New York Heart Association (NYHA) class II or greater congestive heart failure
- History of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or
subarachnoid hemorrhage within six months of the first date of study therapy
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
David E Cohn, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01199263
Organization ID
NCI-2011-02654
Secondary IDs
NCI-2011-02654
Responsible Party
Sponsor
Study Sponsor
National Cancer Institute (NCI)
Collaborators
NRG Oncology
Study Sponsor
David E Cohn, Principal Investigator, NRG Oncology
Verification Date
August 2020