Carboplatin and Paclitaxel With or Without Viral Therapy in Treating Patients With Recurrent or Metastatic Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT01280058|
Recruitment Status : Completed
First Posted : January 20, 2011
Results First Posted : February 7, 2018
Last Update Posted : March 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Acinar Cell Carcinoma Pancreatic Ductal Adenocarcinoma Recurrent Pancreatic Carcinoma Stage IV Pancreatic Cancer||Drug: Carboplatin Other: Laboratory Biomarker Analysis Drug: Paclitaxel Biological: Wild-type Reovirus||Phase 2|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||73 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||December 2010|
|Actual Primary Completion Date :||January 19, 2016|
|Actual Study Completion Date :||January 20, 2016|
Experimental: Arm I (wild-type reovirus, carboplatin, paclitaxel)
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.
Other: Laboratory Biomarker Analysis
Biological: Wild-type Reovirus
Other Name: Reolysin
Experimental: Arm II (carboplatin, paclitaxel)
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.
Other: Laboratory Biomarker Analysis
- Progression-free Survival Using RECIST v. 1.1 [ Time Frame: From study entry to the date of documented progression and/or death, assessed up to 4 years ]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.
- 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 [ Time Frame: Up to 4 years ]Toxicities will be described for each treatment arm, but will also be compared between the arms. Fisher's exact tests will be used to quantitatively compare the incidence of severe as well as specific toxicities of interest between the treatment arms and we will graphically assess differences in maximum grades observed for toxicities between the arms.
- Overall Response Rate (Partial or Complete Response) Evaluated Using the Standard RECIST v. 1.1 [ Time Frame: Up to 4 years ]95% confidence intervals will be calculated. Differences in objective response rates between the treatment arms will be assessed using Fisher's exact test.
- Overall Survival [ Time Frame: From study entry to the time of death due to any cause, assessed up to 4 years ]Evaluated and compared between the two treatment groups using log-rank statistics and graphically using the methods of Kaplan and Meier.
- Immunologic Correlative Markers [ Time Frame: Up to day 1 of course 12 ]The inflammatory cytokine profile, immune effector cell phenotype and function, and NARA titers will be assessed and compared. Patterns of change in the longitudinal data on these markers will be evaluated for each of the correlative outcomes of interest.
- Percentage of Patients With Ras Pathway Activation [ Time Frame: Baseline ]The 95% confidence interval will be assessed. Cochran-Mantel-Haenszel test will be used to assess differences in the relationships between response and Ras pathway activation and the association of treatment groups on these relationships.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01280058
|United States, District of Columbia|
|MedStar Georgetown University Hospital|
|Washington, District of Columbia, United States, 20007|
|United States, Georgia|
|Emory University/Winship Cancer Institute|
|Atlanta, Georgia, United States, 30322|
|United States, New York|
|Montefiore Medical Center-Weiler Hospital|
|Bronx, New York, United States, 10461|
|Montefiore Medical Center - Moses Campus|
|Bronx, New York, United States, 10467-2490|
|United States, Ohio|
|Ohio State University Comprehensive Cancer Center|
|Columbus, Ohio, United States, 43210|
|United States, Oklahoma|
|University of Oklahoma Health Sciences Center|
|Oklahoma City, Oklahoma, United States, 73104|
|Principal Investigator:||Anne Noonan||Ohio State University Comprehensive Cancer Center|