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Phase 2 N=73 Randomized Treatment

Carboplatin and Paclitaxel With or Without Viral Therapy in Treating Patients With Recurrent or Metastatic Pancreatic Cancer

Pancreatic Acinar Cell Carcinoma · Pancreatic Ductal Adenocarcinoma · Recurrent Pancreatic Carcinoma · Stage IV Pancreatic Cancer

Enrolled (actual)
73
Serious AEs
100.0%
Results posted
Feb 2018
Primary outcome: Primary: Progression-free Survival Using RECIST v. 1.1 — 4.9; 5.2 months

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Carboplatin (Drug); Laboratory Biomarker Analysis (Other); Paclitaxel (Drug); Wild-type Reovirus (Biological)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
National Cancer Institute (NCI)
Primary completion
Jan 2016

Outcome Measures

OutcomeResultp-value
PRIMARY
Progression-free Survival Using RECIST v. 1.1
4.9; 5.2
SECONDARY
Incidence of Severe (Grade 3+) Adverse Events That Are Classified as Either Possibly, Probably, or Definitely Related to Study Treatment, as Assessed by NCI CTCAE Version 4.0
56; 59; 33; 46; 28; 24
SECONDARY
Overall Response Rate (Partial or Complete Response) Evaluated Using the Standard RECIST v. 1.1
7; 7; 0; 0
SECONDARY
Overall Survival
7.3; 8.8

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 = = 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 = = 60 mL/min
  • Bilirubin = = 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01280058). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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