Carboplatin and Paclitaxel With or Without Viral Therapy in Treating Patients With Recurrent or Metastatic Pancreatic Cancer
Condition: Pancreatic Acinar Cell Carcinoma; Pancreatic Ductal Adenocarcinoma; Recurrent Pancreatic Carcinoma; Stage IV Pancreatic Cancer
MeSH terms: Carcinoma; Pancreatic Neoplasms; Carcinoma, Acinar Cell; Recurrence
Intervention: Carboplatin; Laboratory Biomarker Analysis; Paclitaxel; Wild-type Reovirus
Intervention description: Given IV; Correlative studies; Given IV; Given IV
Intervention MeSH terms: Paclitaxel; Carboplatin; Albumin-Bound Paclitaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 73.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well carboplatin and paclitaxel with or without viral therapy
      works in treating patients with pancreatic cancer that has come back or has spread to other
      places in the body. Drugs used in chemotherapy, such as carboplatin and 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 from spreading. Viral therapy may be able to kill
      tumor cells without damaging normal cells. It is not yet known whether carboplatin and
      paclitaxel are more effective with or without viral therapy in treating pancreatic cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed adenocarcinoma of the pancreas that is recurrent or
             metastatic; cytological confirmation is not allowed on this study; paraffin embedded
             tissue from tumor blocks will be required from patients before enrolling on this
             study; diagnosis of pancreas cancer with histologic confirmation of adenocarcinoma
             would suffice

          -  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 International System of Units (SI)
             units

          -  Platelet count >= 100 x10^9/L SI units

          -  Hemoglobin >= 8.5 g/dL SI units

          -  Serum creatinine =< 1.5 mg/dL OR creatinine clearance >= 60 mL/min

          -  Bilirubin =< upper limit of normal (ULN) (=< 2 x ULN if it is non-rising for a period
             of 10 days prior to initiation of therapy)

          -  Aspartate 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

          -  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 metastases

          -  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, version [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; breastfeeding should be discontinued
             while the mother is being treated with the agents in this clinical trial