Trial Outcomes & Findings for Pilot, Neoadjuvant Gemcitabine and Abraxane Chemotherapy Followed by Surgery, Adenocarcinoma of the Pancreas (NCT NCT01783054)

Last Updated: 2016-03-08

Results Overview

Estimate the rate of good histopathologic tumor response to neoadjuvant chemotherapy assessed in resection specimen. A good response is defined as a grade III or IV histopathologic appearance, equivalent to \<10% viable tumor.

Recruitment status

TERMINATED

Study phase

EARLY_PHASE1

Target enrollment

2 participants

Primary outcome timeframe

at time of surgery

Results posted on

2016-03-08

Participant Flow

Participant milestones

Participant milestones
Measure	Chemotherapy, Surgery All subjects enrolled on study will start study treatment on a chemotherapy treatment regimen of Gemcitabine and abraxane. Gemcitabine and abraxane will be given on days 1, 8 and 15 of each cycle for 2 cycles over the course of 12 weeks, then surgery.
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pilot, Neoadjuvant Gemcitabine and Abraxane Chemotherapy Followed by Surgery, Adenocarcinoma of the Pancreas

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Chemotherapy, Surgery n=2 Participants All subjects enrolled on study will start study treatment on a chemotherapy treatment regimen of Gemcitabine and abraxane. Gemcitabine and abraxane will be given on days 1, 8 and 15 of each cycle for 2 cycles over the course of 12 weeks, then surgery.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants

PRIMARY outcome

Timeframe: at time of surgery

Population: The study terminated early and the data for this outcome measure was not documented.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: at time of surgery

Population: Subjects who had surgical resection are included in the analysis for this endpoint.

R0 resection status is a macroscopic complete removal of tumor by non-contaminated operation, with neither macroscopic nor microscopic residual tumor.

Outcome measures

Outcome measures
Measure	Chemotherapy, Surgery n=2 Participants All subjects enrolled on study will start study treatment on a chemotherapy treatment regimen of Gemcitabine and abraxane. Gemcitabine and abraxane will be given on days 1, 8 and 15 of each cycle for 2 cycles over the course of 12 weeks, then surgery.
Number of Participants With R0 Resection Status.	2 participants

SECONDARY outcome

Timeframe: 2 years

Population: Only subjects who had surgical resection are included in the analysis for this endpoint. At the time of these results, one subject expired due to disease progression. The other subject was still alive at the time of termination, so is not included in the outcome measure data below.

Time to recurrence is defined as the time from surgical resection to disease recurrence or death from any cause. Patients who have not recurred at the end of follow up will have their recurrence time censored at the last date of contact.

Outcome measures

Outcome measures
Measure	Chemotherapy, Surgery n=1 Participants All subjects enrolled on study will start study treatment on a chemotherapy treatment regimen of Gemcitabine and abraxane. Gemcitabine and abraxane will be given on days 1, 8 and 15 of each cycle for 2 cycles over the course of 12 weeks, then surgery.
Estimate Median Time to Recurrence.	329 days

SECONDARY outcome

Timeframe: 2 years

Overall survival is defined as the time from enrollment to death from any cause. Patients still alive at the end of follow up will have their survival time censored at the last date of contact.

Outcome measures

Outcome measures
Measure	Chemotherapy, Surgery n=1 Participants All subjects enrolled on study will start study treatment on a chemotherapy treatment regimen of Gemcitabine and abraxane. Gemcitabine and abraxane will be given on days 1, 8 and 15 of each cycle for 2 cycles over the course of 12 weeks, then surgery.
Estimate Median Overall Survival	465 days

SECONDARY outcome

Timeframe: First study drug administration until end of study

Population: All subjects who were administered study intervention and had documented adverse events were analyzed. The number below represents the number of adverse events, including serious adverse events, reported on by enrolled subjects. A complete list of the adverse events reported are in the adverse events tables of these results.

Assess the safety profile of this neoadjuvant regimen in patients with localized pancreatic adenocarcinoma. All toxicities will be reported by type and grade and tabulated. All adverse events will be reported via case report forms. The intensity of any adverse event should be reported according to the NCI Common Terminology Criteria for Adverse Events v4.0.

Outcome measures

Outcome measures
Measure	Chemotherapy, Surgery n=2 Participants All subjects enrolled on study will start study treatment on a chemotherapy treatment regimen of Gemcitabine and abraxane. Gemcitabine and abraxane will be given on days 1, 8 and 15 of each cycle for 2 cycles over the course of 12 weeks, then surgery.
Number of Adverse Events Reported in Subjects Enrolled.	60 adverse events

OTHER_PRE_SPECIFIED outcome

Timeframe: From enrollment to surgery

Population: This outcome measure was added as part of an amendment. No subjects were enrolled after this amendment was instituted, so no outcomes measures were collected.

To evaluate and describe CTC number, CTC phenotype characteristics and effectiveness/rate of CTC culturing techniquen from patients with pancreatic adenocarcinoma. To determine and evaluate the correlation between expression of biomarkers in CTCs and expression of biomarkers in resected tissue specimen with the same cancer patient.

Outcome measures

Outcome data not reported

Adverse Events

Chemotherapy, Surgery

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Chemotherapy, Surgery n=2 participants at risk All subjects enrolled on study will start study treatment on a chemotherapy treatment regimen of Gemcitabine and abraxane. Gemcitabine and abraxane will be given on days 1, 8 and 15 of each cycle for 2 cycles over the course of 12 weeks, then surgery.
Hepatobiliary disorders cholangitis	50.0% 1/2 • Number of events 1
Hepatobiliary disorders biliary stent drainage	50.0% 1/2 • Number of events 1
Renal and urinary disorders renal insuffiency	50.0% 1/2 • Number of events 1
General disorders fever	50.0% 1/2 • Number of events 1

Other adverse events

Other adverse events
Measure	Chemotherapy, Surgery n=2 participants at risk All subjects enrolled on study will start study treatment on a chemotherapy treatment regimen of Gemcitabine and abraxane. Gemcitabine and abraxane will be given on days 1, 8 and 15 of each cycle for 2 cycles over the course of 12 weeks, then surgery.
Blood and lymphatic system disorders anemia	100.0% 2/2 • Number of events 2
Blood and lymphatic system disorders hemolytic uremic syndrome	50.0% 1/2 • Number of events 1
Blood and lymphatic system disorders leukocytosis	50.0% 1/2 • Number of events 1
Cardiac disorders aortic valve disease	50.0% 1/2 • Number of events 1
Gastrointestinal disorders nausea	100.0% 2/2 • Number of events 2
Gastrointestinal disorders vomiting	100.0% 2/2 • Number of events 2
Gastrointestinal disorders abdominal pain	50.0% 1/2 • Number of events 1
Gastrointestinal disorders diarrhea	50.0% 1/2 • Number of events 1
Gastrointestinal disorders dysphagia	50.0% 1/2 • Number of events 1
Gastrointestinal disorders flatulence	50.0% 1/2 • Number of events 1
General disorders edema limb	100.0% 2/2 • Number of events 2
General disorders flu like symptoms	50.0% 1/2 • Number of events 1
General disorders fatigue	50.0% 1/2 • Number of events 1
General disorders pain	50.0% 1/2 • Number of events 1
Infections and infestations upper respiratory infection	50.0% 1/2 • Number of events 1
Injury, poisoning and procedural complications biliary anastomic leak	50.0% 1/2 • Number of events 1
Injury, poisoning and procedural complications wound complication	50.0% 1/2 • Number of events 1
Investigations ALT increased	100.0% 2/2 • Number of events 2
Investigations AST increased	100.0% 2/2 • Number of events 2
Investigations creatinine increased	100.0% 2/2 • Number of events 2
Investigations alkaline phosphatase increased	50.0% 1/2 • Number of events 1
Investigations blood bilirubin increased	50.0% 1/2 • Number of events 1
Investigations lymphocyte count decreased	50.0% 1/2 • Number of events 1
Investigations neutrophil count decreased	50.0% 1/2 • Number of events 1
Investigations platelet count decreased	50.0% 1/2 • Number of events 1
Investigations urine output decreased	50.0% 1/2 • Number of events 1
Investigations weight loss	50.0% 1/2 • Number of events 1
Investigations white blood cell decreased	50.0% 1/2 • Number of events 1
Metabolism and nutrition disorders hypoalbuminemia	100.0% 2/2 • Number of events 2
Metabolism and nutrition disorders hypocalcemia	100.0% 2/2 • Number of events 2
Investigations hypokalemia	100.0% 2/2 • Number of events 2
Metabolism and nutrition disorders anorexia	50.0% 1/2 • Number of events 1
Metabolism and nutrition disorders hyperglycemia	50.0% 1/2 • Number of events 1
Metabolism and nutrition disorders hyperkalemia	50.0% 1/2 • Number of events 1
Metabolism and nutrition disorders hypernatremia	50.0% 1/2 • Number of events 1
Metabolism and nutrition disorders hypoglycemia	50.0% 1/2 • Number of events 1
Metabolism and nutrition disorders hypomagnesemia	50.0% 1/2 • Number of events 1
Metabolism and nutrition disorders hyponatremia	50.0% 1/2 • Number of events 1
Metabolism and nutrition disorders hypophosphatemia	50.0% 1/2 • Number of events 1
Metabolism and nutrition disorders neck pain	50.0% 1/2 • Number of events 1
Metabolism and nutrition disorders agitation	50.0% 1/2 • Number of events 1
Renal and urinary disorders urinary incontinence	50.0% 1/2 • Number of events 1
Renal and urinary disorders urine discoloration	50.0% 1/2 • Number of events 1
Respiratory, thoracic and mediastinal disorders cough	50.0% 1/2 • Number of events 1
Vascular disorders hypertension	50.0% 1/2 • Number of events 1
Vascular disorders hypotension	50.0% 1/2 • Number of events 1

Additional Information

Eric Kimchi, MD

Medical University of South Carolina

Phone: 842-792-4271

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place