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
After completion of study therapy, patients are followed up at 1 month and then every 2
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
From study entry to the date of documented progression and/or death, assessed up to 3 years
Ohio State University
United States: Food and Drug Administration
|Memorial Sloan Kettering Cancer Center||New York, New York 10021|
|University of Oklahoma Health Sciences Center||Oklahoma City, Oklahoma 73104|
|Montefiore Medical Center||Bronx, New York 10467-2490|
|Emory University||Atlanta, Georgia 30322|
|Ohio State University Medical Center||Columbus, Ohio 43210|
|Lombardi Comprehensive Cancer Center at Georgetown University||Washington, District of Columbia 20057|