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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


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Recurrent Fallopian Tube Cancer, Recurrent Ovarian Epithelial Cancer, Recurrent Primary Peritoneal Cavity Cancer

Thank you

Trial Information

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.


Inclusion Criteria:



- Histologically confirmed diagnosis of ovarian epithelial, fallopian tube, or primary
peritoneal cancer

- Recurrent or persistent disease

- Measurable or detectable (non-measurable) disease

- Measurable disease is defined as ≥ 1 lesion that can be accurately measured in 1
dimension (longest diameter to be recorded) as ≥ 10 mm by CT scan, MRI, or
caliper measurement by clinical exam or as ≥ 20 mm when measured by chest x-ray;
lymph nodes must be ≥ 15 mm in short axis when measured by CT scan or MRI

- Patients with measurable disease must have ≥ 1 "target lesion" to be used
to assess response to study treatment as defined by RECIST 1.1 (tumors
within a previously irradiated field will be designated as "non-target"
lesion unless progression is documented or a biopsy is obtained to confirm
persistence ≥ 90 days after completion of radiotherapy)

- Detectable disease is defined as not having measurable disease, but having ≥ 1
of the following conditions:

- Baseline values of CA-125 ≥ 2 times 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

- Not eligible for a higher priority GOG study, if one exists (in general, this would
refer to any active GOG phase III protocol or Rare Tumor protocol for the same
patient population)

- Received 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, the
paclitaxel may have been administered weekly or every 3 weeks

- GOG performance status (PS) 0-2 (for patients who have received one prior regimen) OR
GOG PS 0-1 (for patients who have received two or three prior regimens)

- ANC ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 9 g/dL

- Creatinine ≤ 1.5 times ULN

- Bilirubin ≤ 1.5 times ULN

- SGOT ≤ 3 times ULN

- Alkaline phosphatase ≤ 2.5 times ULN

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- 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 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

- Sensory and motor neuropathy ≤ grade 1

- No clinically significant cardiovascular disease, including any of the following:

- Myocardial infarction or unstable angina within the past 6 months

- History of serious ventricular arrhythmia (i.e., ventricular tachycardia or
ventricular fibrillation) or cardiac arrhythmias requiring antiarrhythmic
mediations (except for atrial fibrillation that is well controlled with
antiarrhythmic medication)

- Troponin I > ULN

- Baseline ejection fraction ≤ 50% as assessed by ECHO or MUGA

- NYHA class II-IV congestive heart failure

- History of cerebrovascular accident, transient ischemic attack, or subarachnoid
hemorrhage within the past 6 months

- No history of other invasive malignancies within the past 3 years except for
nonmelanoma skin cancer

- No history of primary endometrial cancer unless all of the following criteria are
met:

- Stage not greater than IB

- No more than superficial myometrial invasion without vascular or lymphatic
invasion

- No poorly differentiated subtypes, including papillary serous, clear cell, or
other FIGO grade 3 lesions

- No known HIV or hepatitis B or C

- No active infection requiring antibiotics (except for uncomplicated urinary tract
infection)

- No concurrent acetaminophen (if receiving wild-type reovirus)

- No prior wild-type reovirus or other oncolytic virus

- No prior cancer treatment that contraindicates study treatment

- Two additional cytotoxic regimens for management of recurrent or persistent disease
allowed, with ≤ 1 non-platinum, non-taxane regimen

- No prior weekly paclitaxel for recurrent or persistent disease

- Biologic/targeted (non-cytotoxic) therapy as part of the primary treatment regimen or
as part of treatment for recurrent or persistent disease allowed

- Prior non-cytotoxic therapy alone not counted as prior regimen

- No prior non-cytotoxic therapy for recurrent or persistent disease

- Patients who have received only one prior cytotoxic regimen (platinum-based regimen
for management of primary disease) must meet one of the following criteria:

- Platinum-free interval of < 12 months

- Progressed during platinum-based therapy

- Have persistent disease after a platinum-based therapy

- Recovered from effects of recent surgery, radiotherapy, or chemotherapy

- No 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
past 3 years

- Prior radiotherapy for localized cancer of the breast, head and neck, or skin is
allowed provided that it was completed > 3 years ago and that the patient
remains free of recurrent or metastatic disease

- No prior chemotherapy for any abdominal or pelvic tumor OTHER THAN for the treatment
of ovarian, fallopian tube, or primary peritoneal cancer within the past 3 years

- Prior adjuvant chemotherapy for localized breast cancer is allowed provided that
it was completed > 3 years ago and that the patient remains free of recurrent or
metastatic disease

- At least 3 weeks since prior therapy directed at the malignant tumor, including
chemotherapy, biologic/targeted and immunologic agents

- At least 1 week since prior hormonal therapy directed at the malignant tumor

- Concurrent hormone replacement therapy allowed

- No concurrent immunosuppressive therapy, including chronic oral steroids (at an
equivalent dose of > 5 mg/day of prednisone)

- No other concurrent investigational therapy, immunotherapy, or chemotherapy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival (PFS)

Outcome Time Frame:

Up to 5 years

Safety Issue:

No

Principal Investigator

David Cohn

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gynecologic Oncology Group

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2011-02654

NCT ID:

NCT01199263

Start Date:

December 2010

Completion Date:

Related Keywords:

  • Recurrent Fallopian Tube Cancer
  • Recurrent Ovarian Epithelial Cancer
  • Recurrent Primary Peritoneal Cavity Cancer
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms
  • Neoplasms, Glandular and Epithelial
  • Ovarian Neoplasms

Name

Location

Mayo ClinicRochester, Minnesota  55905
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Hurley Medical CenterFlint, Michigan  48503
University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma  73104
University of New Mexico Cancer CenterAlbuquerque, New Mexico  87131-5636
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical CenterColumbus, Ohio  43210-1240
Saint Joseph Mercy HospitalAnn Arbor, Michigan  48106
Northeast Georgia Medical CenterGainesville, Georgia  30501
Genesys Regional Medical CenterGrand Blanc, Michigan  48439-8066
Saint Alphonsus Regional Medical CenterBoise, Idaho  83706
Case Western Reserve UniversityCleveland, Ohio  44106
Indiana University Medical CenterIndianapolis, Indiana  46202
Providence Saint Joseph Medical CenterBurbank, California  91505-4866
Saint Francis Hospital and Medical CenterHartford, Connecticut  06105
Michigan Cancer Research Consortium Community Clinical Oncology ProgramAnn Arbor, Michigan  48106
Oakwood HospitalDearborn, Michigan  48123
Saint John Hospital and Medical CenterDetroit, Michigan  48236
Allegiance HealthJackson, Michigan  49201
Sparrow HospitalLansing, Michigan  48912
Saint Mary Mercy HospitalLivonia, Michigan  48154
Saint Joseph Mercy OaklandPontiac, Michigan  48341-2985
Saint Joseph Mercy Port HuronPort Huron, Michigan  48060
Saint Mary's of MichiganSaginaw, Michigan  48601
Saint John Macomb-Oakland HospitalWarren, Michigan  48093
Lake University Ireland Cancer CenterMentor, Ohio  44060
Carilion Clinic Gynecological OncologyRoanoke, Virginia  24016
Women's Cancer Center of NevadaLas Vegas, Nevada  89109
Palo Alto Medical Foundation-Gynecologic OncologyMountain View, California  94040