Trial Outcomes & Findings for Phase 2 Evaluation of Multi-modality Algorithm for Non-metastatic Adenocarcinoma of Pancreas or Ampulla (NCT NCT02626520)

NCT ID: NCT02626520

Last Updated: 2018-11-13

Results Overview

Percentage of patients alive and free of detectable disease 1 yr from start of treatment

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 11 participants
• Primary outcome timeframe: 1 yr form onset of treatment
• Results posted on: 2018-11-13

Participant Flow

Participant milestones

Measure	Resectable, Low Risk Systemic chemotherapy followed by definitive surgery without pre-operative or post-operative radiotherapy. Gemcitabine and nanoparticle albumin bound paclitaxel: Gemcitabine and nab-paclitaxel given every 14 days x 4 cycles Definitive resection: Definitive surgical resection of primary tumor	Locally Advanced Systemic chemotherapy followed by chemoradiation, followed by definitive surgery Gemcitabine and nanoparticle albumin bound paclitaxel: Gemcitabine and nab-paclitaxel given every 14 days x 4 cycles 5-fluorouracil and irinotecan: FOLFIRI.3 given every 14 days x 4 cycles Preoperative chemoradiation: Pre-operative chemoradiation to 40 Gy in 20 fractions Definitive resection: Definitive surgical resection of primary tumor
Overall Study STARTED	1	10
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	1	10

Reasons for withdrawal

Measure	Resectable, Low Risk Systemic chemotherapy followed by definitive surgery without pre-operative or post-operative radiotherapy. Gemcitabine and nanoparticle albumin bound paclitaxel: Gemcitabine and nab-paclitaxel given every 14 days x 4 cycles Definitive resection: Definitive surgical resection of primary tumor	Locally Advanced Systemic chemotherapy followed by chemoradiation, followed by definitive surgery Gemcitabine and nanoparticle albumin bound paclitaxel: Gemcitabine and nab-paclitaxel given every 14 days x 4 cycles 5-fluorouracil and irinotecan: FOLFIRI.3 given every 14 days x 4 cycles Preoperative chemoradiation: Pre-operative chemoradiation to 40 Gy in 20 fractions Definitive resection: Definitive surgical resection of primary tumor
Overall Study Physician Decision	1	1
Overall Study Adverse Event	0	4
Overall Study Lack of Efficacy	0	2
Overall Study Did not start protocol therapy	0	2
Overall Study Study terminated	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Resectable, Low Risk n=1 Participants Systemic chemotherapy followed by definitive surgery without pre-operative or post-operative radiotherapy. Gemcitabine and nanoparticle albumin bound paclitaxel: Gemcitabine and nab-paclitaxel given every 14 days x 4 cycles Definitive resection: Definitive surgical resection of primary tumor	Locally Advanced n=10 Participants Systemic chemotherapy followed by chemoradiation, followed by definitive surgery Gemcitabine and nanoparticle albumin bound paclitaxel: Gemcitabine and nab-paclitaxel given every 14 days x 4 cycles 5-fluorouracil and irinotecan: FOLFIRI.3 given every 14 days x 4 cycles Preoperative chemoradiation: Pre-operative chemoradiation to 40 Gy in 20 fractions Definitive resection: Definitive surgical resection of primary tumor	Total n=11 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=1 Participants	0 Participants n=10 Participants	0 Participants n=11 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=1 Participants	7 Participants n=10 Participants	8 Participants n=11 Participants
Age, Categorical >=65 years	0 Participants n=1 Participants	3 Participants n=10 Participants	3 Participants n=11 Participants
Age, Continuous	64 years n=1 Participants	63 years n=10 Participants	63 years n=11 Participants
Sex: Female, Male Female	1 Participants n=1 Participants	6 Participants n=10 Participants	7 Participants n=11 Participants
Sex: Female, Male Male	0 Participants n=1 Participants	4 Participants n=10 Participants	4 Participants n=11 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	1 participants n=1 Participants	10 participants n=10 Participants	11 participants n=11 Participants

PRIMARY outcome

Timeframe: 1 yr form onset of treatment

Population: Due to excessive toxicity of study regimen, the study was permanently closed prior to data analysis.

Percentage of patients alive and free of detectable disease 1 yr from start of treatment

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time of surgery

Population: Data not collected, study Terminated

Rate of patients having surgery who have negative surgical margins (i.e. R-0 resection)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 3 years from registration

Population: Data not collected, study terminated

Time to death from any cause measured from start of treatment

Outcome measures

Outcome data not reported

Adverse Events

Resectable, Low Risk

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Locally Advanced

Serious events: 3 serious events

Other events: 2 other events

Deaths: 1 deaths

Serious adverse events

Measure	Resectable, Low Risk n=1 participants at risk Systemic chemotherapy followed by definitive surgery without pre-operative or post-operative radiotherapy. Gemcitabine and nanoparticle albumin bound paclitaxel: Gemcitabine and nab-paclitaxel given every 14 days x 4 cycles Definitive resection: Definitive surgical resection of primary tumor	Locally Advanced n=10 participants at risk Systemic chemotherapy followed by chemoradiation, followed by definitive surgery Gemcitabine and nanoparticle albumin bound paclitaxel: Gemcitabine and nab-paclitaxel given every 14 days x 4 cycles 5-fluorouracil and irinotecan: FOLFIRI.3 given every 14 days x 4 cycles Preoperative chemoradiation: Pre-operative chemoradiation to 40 Gy in 20 fractions Definitive resection: Definitive surgical resection of primary tumor
Blood and lymphatic system disorders Neutropenia	0.00% 0/1 • Study enrollment through study termination, on average approximately 3 months	10.0% 1/10 • Number of events 1 • Study enrollment through study termination, on average approximately 3 months
Gastrointestinal disorders diarrhea	0.00% 0/1 • Study enrollment through study termination, on average approximately 3 months	30.0% 3/10 • Number of events 3 • Study enrollment through study termination, on average approximately 3 months

Other adverse events

Measure	Resectable, Low Risk n=1 participants at risk Systemic chemotherapy followed by definitive surgery without pre-operative or post-operative radiotherapy. Gemcitabine and nanoparticle albumin bound paclitaxel: Gemcitabine and nab-paclitaxel given every 14 days x 4 cycles Definitive resection: Definitive surgical resection of primary tumor	Locally Advanced n=10 participants at risk Systemic chemotherapy followed by chemoradiation, followed by definitive surgery Gemcitabine and nanoparticle albumin bound paclitaxel: Gemcitabine and nab-paclitaxel given every 14 days x 4 cycles 5-fluorouracil and irinotecan: FOLFIRI.3 given every 14 days x 4 cycles Preoperative chemoradiation: Pre-operative chemoradiation to 40 Gy in 20 fractions Definitive resection: Definitive surgical resection of primary tumor
Gastrointestinal disorders Nausea	0.00% 0/1 • Study enrollment through study termination, on average approximately 3 months	20.0% 2/10 • Number of events 2 • Study enrollment through study termination, on average approximately 3 months
Gastrointestinal disorders diarrhea	0.00% 0/1 • Study enrollment through study termination, on average approximately 3 months	20.0% 2/10 • Number of events 2 • Study enrollment through study termination, on average approximately 3 months

Additional Information

Dr. Bret Friday

Essentia Health

Phone: 218-786-3625

Email: bret.friday@essentiahealth.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place