Trial Outcomes & Findings for Carboplatin and Paclitaxel With or Without Viral Therapy in Treating Patients With Recurrent or Metastatic Pancreatic Cancer (NCT NCT01280058)

Last Updated: 2018-03-09

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

73 participants

Primary outcome timeframe

From study entry to the date of documented progression and/or death, assessed up to 4 years

Results posted on

2018-03-09

Participant Flow

Patients were randomized between February 2011 and April 2014

Participant milestones

Participant milestones
Measure	Arm A (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. Carboplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Wild-type Reovirus: Given IV	Arm B (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. Carboplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV
Overall Study STARTED	36	37
Overall Study COMPLETED	36	37
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A (Wild-type Reovirus, Carboplatin, Paclitaxel) n=36 Participants 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. Carboplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Wild-type Reovirus: Given IV	Arm B (Carboplatin, Paclitaxel) n=37 Participants 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. Carboplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV	Total n=73 Participants Total of all reporting groups
Age, Continuous	61.5 years n=5 Participants	66 years n=7 Participants	64 years n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	18 Participants n=7 Participants	32 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	19 Participants n=7 Participants	41 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	32 Participants n=5 Participants	35 Participants n=7 Participants	67 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	36 Participants n=5 Participants	37 Participants n=7 Participants	73 Participants n=5 Participants

PRIMARY outcome

Timeframe: From study entry to the date of documented progression and/or death, assessed up to 4 years

Outcome measures

Outcome measures
Measure	Arm A (Wild-type Reovirus, Carboplatin, Paclitaxel) n=36 Participants 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. Carboplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Wild-type Reovirus: Given IV	Arm B (Carboplatin, Paclitaxel) n=37 Participants 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. Carboplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV
Progression-free Survival Using RECIST v. 1.1	4.9 months Interval 3.0 to 6.3	5.2 months Interval 2.3 to 6.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Arm A (Wild-type Reovirus, Carboplatin, Paclitaxel) n=36 Participants 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. Carboplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Wild-type Reovirus: Given IV	Arm B (Carboplatin, Paclitaxel) n=37 Participants 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. Carboplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV
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 Neutropenia	56 percentage of patients	59 percentage of patients
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 Leukopenia	33 percentage of patients	46 percentage of patients
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 Thrombocytopenia	28 percentage of patients	24 percentage of patients
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 Anemia	25 percentage of patients	30 percentage of patients
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 Febrile Neutropenia	8 percentage of patients	11 percentage of patients
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 Fatigue	11 percentage of patients	8 percentage of patients
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 Infection	11 percentage of patients	5 percentage of patients
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 Dose Delay	37 percentage of patients	54 percentage of patients
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 Dose reduction	36 percentage of patients	43 percentage of patients

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Arm A (Wild-type Reovirus, Carboplatin, Paclitaxel) n=36 Participants 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. Carboplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Wild-type Reovirus: Given IV	Arm B (Carboplatin, Paclitaxel) n=37 Participants 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. Carboplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV
Overall Response Rate (Partial or Complete Response) Evaluated Using the Standard RECIST v. 1.1 Complete Response	0 Participants	0 Participants
Overall Response Rate (Partial or Complete Response) Evaluated Using the Standard RECIST v. 1.1 Partial Response	7 Participants	7 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Arm A (Wild-type Reovirus, Carboplatin, Paclitaxel) n=36 Participants 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. Carboplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Wild-type Reovirus: Given IV	Arm B (Carboplatin, Paclitaxel) n=37 Participants 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. Carboplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV
Overall Survival	7.3 months Interval 4.8 to 11.2	8.8 months Interval 6.6 to 11.8

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to day 1 of course 12

Population: data was not collected

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Arm A (Wild-type Reovirus, Carboplatin, Paclitaxel) n=36 Participants 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. Carboplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Wild-type Reovirus: Given IV	Arm B (Carboplatin, Paclitaxel) n=37 Participants 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. Carboplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV
Percentage of Patients With Ras Pathway Activation	71 percentage of patients	75 percentage of patients

Adverse Events

Arm A (Wild-type Reovirus, Carboplatin, Paclitaxel)

Serious events: 36 serious events

Other events: 36 other events

Deaths: 0 deaths

Arm B (Carboplatin, Paclitaxel)

Serious events: 37 serious events

Other events: 37 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Arm A (Wild-type Reovirus, Carboplatin, Paclitaxel) n=36 participants at risk 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. Carboplatin and Paclitaxel were given IV. Wild-type Reovirus: Given IV	Arm B (Carboplatin, Paclitaxel) n=37 participants at risk 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. Carboplatin and Paclitaxel were given IV
Blood and lymphatic system disorders Neutropenia	55.6% 20/36 • Number of events 20 The National Cancer Institutes (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for adverse event grading and reporting.	59.5% 22/37 • Number of events 22 The National Cancer Institutes (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for adverse event grading and reporting.
Blood and lymphatic system disorders Leukopenia	33.3% 12/36 • Number of events 12 The National Cancer Institutes (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for adverse event grading and reporting.	45.9% 17/37 • Number of events 17 The National Cancer Institutes (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for adverse event grading and reporting.
Blood and lymphatic system disorders Thrombocytopenia	27.8% 10/36 • Number of events 10 The National Cancer Institutes (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for adverse event grading and reporting.	24.3% 9/37 • Number of events 9 The National Cancer Institutes (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for adverse event grading and reporting.
Blood and lymphatic system disorders Anemia	25.0% 9/36 • Number of events 9 The National Cancer Institutes (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for adverse event grading and reporting.	29.7% 11/37 • Number of events 11 The National Cancer Institutes (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for adverse event grading and reporting.
Infections and infestations Febrile Neutropenia	8.3% 3/36 • Number of events 3 The National Cancer Institutes (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for adverse event grading and reporting.	10.8% 4/37 • Number of events 4 The National Cancer Institutes (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for adverse event grading and reporting.
General disorders Fatigue	11.1% 4/36 • Number of events 4 The National Cancer Institutes (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for adverse event grading and reporting.	8.1% 3/37 • Number of events 3 The National Cancer Institutes (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for adverse event grading and reporting.
Infections and infestations Infection	11.1% 4/36 • Number of events 4 The National Cancer Institutes (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for adverse event grading and reporting.	5.4% 2/37 • Number of events 2 The National Cancer Institutes (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for adverse event grading and reporting.

Additional Information

Anne Noonan, MD

The Ohio State University Comprehensive Cancer Center

Phone: 614-685-6912

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60