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

Brief summary public domain (ClinicalTrials.gov)

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.

Detailed description public domain (ClinicalTrials.gov)

PRIMARY OBJECTIVES: I. To assess the improvement in progression-free survival with Reolysin (wild-type reovirus), carboplatin, and paclitaxel relative to carboplatin and paclitaxel alone in patients with recurrent or metastatic pancreatic cancer. SECONDARY OBJECTIVES: 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 carboplatin and paclitaxel (CP) modulate factors regulating immunity to reovirus and its persistence in the system circulation of patients with pancreatic cancer. IV. To prospectively establish and validate the relationship between Ras mutations in tumor samples and response to Reolysin. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive paclitaxel intravenously (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. After completion of study treatment, patients are followed up at 1 month and then every 2 months thereafter.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Progression-free Survival Using RECIST v. 1.1 [From study entry to the date of documented progression and/or death, assessed up to 4 years]. Median, months (95% Confidence Interval). Arm A (Wild-type Reovirus, Carboplatin, Paclitaxel) (n=36): 4.9 (3.0 to 6.3); Arm B (Carboplatin, Paclitaxel) (n=37): 5.2 (2.3 to 6.2).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

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 [Up to 4 years]. Number, percentage of patients. Neutropenia: Arm A (Wild-type Reovirus, Carboplatin, Paclitaxel) (n=36): 56; Arm B (Carboplatin, Paclitaxel) (n=37): 59. Leukopenia: Arm A (Wild-type Reovirus, Carboplatin, Paclitaxel) (n=36): 33; Arm B (Carboplatin, Paclitaxel) (n=37): 46. Thrombocytopenia: Arm A (Wild-type Reovirus, Carboplatin, Paclitaxel) (n=36): 28; Arm B (Carboplatin, Paclitaxel) (n=37): 24. Anemia: Arm A (Wild-type Reovirus, Carboplatin, Paclitaxel) (n=36): 25; Arm B (Carboplatin, Paclitaxel) (n=37): 30. Febrile Neutropenia: Arm A (Wild-type Reovirus, Carboplatin, Paclitaxel) (n=36): 8; Arm B (Carboplatin, Paclitaxel) (n=37): 11. Fatigue: Arm A (Wild-type Reovirus, Carboplatin, Paclitaxel) (n=36): 11; Arm B (Carboplatin, Paclitaxel) (n=37): 8. Infection: Arm A (Wild-type Reovirus, Carboplatin, Paclitaxel) (n=36): 11; Arm B (Carboplatin, Paclitaxel) (n=37): 5. Dose Delay: Arm A (Wild-type Reovirus, Carboplatin, Paclitaxel) (n=36): 37; Arm B (Carboplatin, Paclitaxel) (n=37): 54. Dose reduction: Arm A (Wild-type Reovirus, Carboplatin, Paclitaxel) (n=36): 36; Arm B (Carboplatin, Paclitaxel) (n=37): 43.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Overall Response Rate (Partial or Complete Response) Evaluated Using the Standard RECIST v. 1.1 [Up to 4 years]. Count Of Participants, Participants. Partial Response: Arm A (Wild-type Reovirus, Carboplatin, Paclitaxel) (n=36): 7; Arm B (Carboplatin, Paclitaxel) (n=37): 7. Complete Response: Arm A (Wild-type Reovirus, Carboplatin, Paclitaxel) (n=36): 0; Arm B (Carboplatin, Paclitaxel) (n=37): 0.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Overall Survival [From study entry to the time of death due to any cause, assessed up to 4 years]. Median, months (95% Confidence Interval). Arm A (Wild-type Reovirus, Carboplatin, Paclitaxel) (n=36): 7.3 (4.8 to 11.2); Arm B (Carboplatin, Paclitaxel) (n=37): 8.8 (6.6 to 11.8).