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A 2-arm Randomized Phase II Study of Carboplatin, Paclitaxel Plus Reovirus Serotype-3 Dearing Strain (Reolysin®) vs. Carboplatin and Paclitaxel in the First Line Treatment of Patients With Recurrent or Metastatic Pancreatic Cancer

Phase 2
18 Years
Open (Enrolling)
Adenocarcinoma of the Pancreas, Recurrent Pancreatic Cancer, Stage IV Pancreatic Cancer

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Trial Information

A 2-arm Randomized Phase II Study of Carboplatin, Paclitaxel Plus Reovirus Serotype-3 Dearing Strain (Reolysin®) vs. Carboplatin and Paclitaxel in the First Line Treatment of Patients With Recurrent or Metastatic Pancreatic Cancer


I. To assess the improvement in progression-free survival with Reolysin, carboplatin, and
paclitaxel relative to carboplatin and paclitaxel alone in patients with recurrent or
metastatic pancreatic cancer.


I. To evaluate the safety and tolerability of Reolysin in combination with carboplatin and
paclitaxel versus without Reolysin in patients with recurrent or metastatic pancreas cancer.

II. To compare the treatment groups for other efficacy endpoints such as overall response
rate and overall survival.

III. To define how the combination of Reolysin and CP modulate factors regulating immunity
to reovirus and its persistence in the system circulation of patients with pancreatic

IV. To prospectively establish and validate the relationship between Ras mutations in tumor
samples and response to Reolysin.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day
1 and wild-type reovirus IV over 60 minutes on days 1-5. Courses repeat every 21 days in the
absence of disease progression or unacceptable toxicity.

ARM II: Patients receive paclitaxel and carboplatin as in arm I. Courses repeat every 21
days in the absence of disease progression or unacceptable toxicity. Patients with disease
progression may crossover to arm I.

Blood samples and previously collected tumor tissue samples are analyzed for genetic
mutations and/or protein levels of the RAS signaling pathway activation and other
correlative studies.

After completion of study therapy, patients are followed up at 1 month and then every 2
months thereafter.

Inclusion Criteria:

- Histologically confirmed adenocarcinoma of the pancreas that is recurrent or

- Cytological confirmation not allowed

- Paraffin-embedded tissue from tumor blocks required

- Patients must have measurable disease, defined as one lesion that can be accurately
measured in at least one dimension per Response Evaluation Criteria In Solid Tumors
(RECIST) 1.1 (longest diameter to be recorded) as >= 10 mm by spiral computed
tomography (CT) scan (CT scan slice thickness no greater than 5 mm)

- Malignant lymph nodes will be considered measurable if they are >= 15 mm in
short axis

- For patients previously irradiated, the measurable lesion must be outside the
radiated field

- Patients must not have received any prior chemotherapy in metastatic setting;
patients who have received prior chemotherapy in the adjuvant setting will not be
eligible for our study;

- Patients should not have received prior Reolysin;

- Prior palliative radiation therapy or major surgery must have occurred at least
28 days prior to study enrollment;

- Prior minor surgeries (such as laparoscopies) must have occurred at least 14
days prior to study enrollment;

- Prior minor procedures such as biopsies and mediport placement must have
occurred at least 48 hours prior to study enrollment

- Eastern Cooperative Oncology Group (ECOG) status =< 1 (Karnofsky >= 70%)

- Absolute neutrophil count (ANC) >= 1.5 x 10^9/L SI units

- Platelet count >= 100 x10^9/L SI units

- Hemoglobin >= 8.5 g/dL

- Serum creatinine =< 1.5 mg/dL OR creatinine clearance >= 60 mL/min

- Bilirubin =< ULN (=< 2 x upper limit of normal [ULN] if it is non-rising for a period
of 10 days prior to initiation of therapy)

- Aspartete aminotransferase (AST)/alanine aminotransferase (ALT) =< 3 X ULN

- Troponin I < ULN

- All patients must have signed an informed consent indicating that they are aware of
the neoplastic nature of their disease and have been informed of the procedures of
the protocol, the experimental nature of the therapy, alternatives, potential
benefits, side effects, risks, and discomforts

- The effects of Reolysin on the developing human fetus at the recommended therapeutic
dose are unknown; for this reason and because the other chemotherapeutic agents used
in this trial are known to be teratogenic, women of child-bearing potential and men
must agree to use adequate contraception (hormonal or barrier method of birth
control; abstinence) prior to study entry and for the duration of study
participation; should a woman become pregnant or suspect she is pregnant while
participating in this study, she should inform her treating physician immediately;
patients must be able to avoid direct contact with pregnant or nursing women, infants
and immunocompromised individuals while on study and for >= 3 weeks following the
last dose of Reolysin administration

- All patients must be willing and able to comply with scheduled visits, the treatment
plan, and laboratory tests

Exclusion Criteria:

- Patients may not be receiving any other investigational agents or concurrent therapy
with other anti-cancer agents while on study

- Patients with untreated brain metastases will be excluded from this clinical trial;
however, patients with resected oligometastasis are eligible if postresection
magnetic resonance imaging (MRI) demonstrates resolution; gamma-knife treated
patients are also eligible if there are no more than two treated metastases confined
to the same area of the brain and a post treatment MRI shows a decrease in the

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to Reolysin or other agents used in the study

- Patients may not have received any viral-based therapy within the past 6 months

- Patients must have NO continuing acute toxic effects (except alopecia) of any prior
radiotherapy, chemotherapy, or surgical procedures; all such effects must have
resolved to Common Terminology Criteria for Adverse Events (CTCAE, v. 4 ) Grade =< 1
prior to study enrollment

- Patients must not have grade 2 or higher baseline peripheral neuropathy according to
CTCAE v. 4

- Patients with uncontrolled cardiac dysfunction or arrhythmia, including a myocardial
infarction in the preceding 6 months, known cardiac ejection fraction < 40%,
symptomatic congestive heart failure, or unstable angina pectoris

- Patients must not be receiving concurrent systemic immunosuppressive therapy

- Patients must not have known human immunodeficiency virus (HIV) infection or active
hepatitis B or C

- Patients must not have uncontrolled intercurrent illness including, but not limited
to, ongoing or active infection or known psychiatric illness/social situations that
would limit compliance with study requirements

- Patients must not have dementia or altered mental status that would prohibit
informed consent

- Patients must not have other known severe, acute, or chronic medical or psychiatric
condition or laboratory abnormality that may increase the risk associated with study
participation, study drug administration, or may interfere with the interpretation of
study results that, in the judgment of the Principal Investigator, would make the
patient inappropriate for this study

- Pregnant women are excluded from this study because of the potential for teratogenic
or abortifacient effects; because there is an unknown but potential risk for adverse
events in nursing infants secondary to treatment of the mother with Reolysin,
breastfeeding should be discontinued while the mother is being treated with the
agents in this clinical trial

Type of Study:


Study Design:

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

Outcome Measure:

Progression-free survival

Outcome Description:

The progression-free survival distributions between the two arms will be compared using log-rank tests. Progression-free survival curves will be constructed using the Kaplan-Meier product limit method, and additional analyses will be done using the Cox proportional hazards model.

Outcome Time Frame:

From study entry to the date of documented progression and/or death, assessed up to 3 years

Safety Issue:


Principal Investigator

Tanios Bekaii-Saab

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University


United States: Food and Drug Administration

Study ID:




Start Date:

December 2010

Completion Date:

Related Keywords:

  • Adenocarcinoma of the Pancreas
  • Recurrent Pancreatic Cancer
  • Stage IV Pancreatic Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Pancreatic Neoplasms



Memorial Sloan Kettering Cancer CenterNew York, New York  10021
University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma  73104
Montefiore Medical CenterBronx, New York  10467-2490
Emory UniversityAtlanta, Georgia  30322
Ohio State University Medical CenterColumbus, Ohio  43210
Lombardi Comprehensive Cancer Center at Georgetown UniversityWashington, District of Columbia  20057