Trial Outcomes & Findings for FOLFIRINOX in Patients With Inoperable Pancreatic Cancer (NCT NCT01359007)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

5 participants

Primary outcome timeframe

2 years

Results posted on

2018-03-09

Participant Flow

Participant milestones

Participant milestones
Measure	FOLFIRINOX Combination of drugs (Irinotecan, Oxaliplatin, Leucovorin, and 5-Fluorouracil (5-FU)) known as FOLFIRINOX every 2 weeks for 4 treatments. At the end of 4 cycles, patients will be re-evaluated for resectability by CT scan within 28 days of the last dose of chemo. If found amendable to surgery, patient will proceed with resection, and type of resection (R0 or R1) will be recorded. Irinotecan, Oxaliplatin, Leucovorin, 5-FU: 5-FU 2400 mg/m2 IV continuous infusion for 46-48 hours Days 1-3 for 2 weeks 5-FU 400 mg/m2 IV Bolus Day 1 Oxaliplatin 85 mg/m2 IV over 120min +/-30 min. Day 1 Irinotecan 180 mg/m2 IV to run over 90 min +/- 30 min Day 1 Leucovorin (Before bolus 5-FU) 400 mg/m2 IV over 120 min. +/- 30 Day 1 May give oxaliplatin and leucovorin concurrently
Overall Study STARTED	5
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

FOLFIRINOX in Patients With Inoperable Pancreatic Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FOLFIRINOX n=5 Participants Combination of drugs (Irinotecan, Oxaliplatin, Leucovorin, and 5-Fluorouracil (5-FU)) known as FOLFIRINOX every 2 weeks for 4 treatments. At the end of 4 cycles, patients will be re-evaluated for resectability by CT scan within 28 days of the last dose of chemo. If found amendable to surgery, patient will proceed with resection, and type of resection (R0 or R1) will be recorded. Irinotecan, Oxaliplatin, Leucovorin, 5-FU: 5-FU 2400 mg/m2 IV continuous infusion for 46-48 hours Days 1-3 for 2 weeks 5-FU 400 mg/m2 IV Bolus Day 1 Oxaliplatin 85 mg/m2 IV over 120min +/-30 min. Day 1 Irinotecan 180 mg/m2 IV to run over 90 min +/- 30 min Day 1 Leucovorin (Before bolus 5-FU) 400 mg/m2 IV over 120 min. +/- 30 Day 1 May give oxaliplatin and leucovorin concurrently
Age, Continuous	60 years n=5 Participants
Sex: Female, Male sex · Female	2 Participants n=5 Participants
Sex: Female, Male sex · Male	3 Participants n=5 Participants
Race (NIH/OMB) Race · American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Race · Asian	0 Participants n=5 Participants
Race (NIH/OMB) Race · Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Race · Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) Race · White	3 Participants n=5 Participants
Race (NIH/OMB) Race · More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Race · Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Population: Data was not collected from any single study participant.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Population: Data was not collected from any single study participant

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Population: Data was not collected from any single study participant.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Population: Data was not collected from any single study participant.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Outcome measures
Measure	5-FU, Leucovorin, Oxaliplatin, Irinotecan n=5 Participants As per above
Number of Participants Who Experienced Toxicity	2 Participants

Adverse Events

FOLFIRINOX

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	FOLFIRINOX n=5 participants at risk Combination of drugs (Irinotecan, Oxaliplatin, Leucovorin, and 5-Fluorouracil (5-FU)) known as FOLFIRINOX every 2 weeks for 4 treatments. At the end of 4 cycles, patients will be re-evaluated for resectability by CT scan within 28 days of the last dose of chemo. If found amendable to surgery, patient will proceed with resection, and type of resection (R0 or R1) will be recorded. Irinotecan, Oxaliplatin, Leucovorin, 5-FU: 5-FU 2400 mg/m2 IV continuous infusion for 46-48 hours Days 1-3 for 2 weeks 5-FU 400 mg/m2 IV Bolus Day 1 Oxaliplatin 85 mg/m2 IV over 120min +/-30 min. Day 1 Irinotecan 180 mg/m2 IV to run over 90 min +/- 30 min Day 1 Leucovorin (Before bolus 5-FU) 400 mg/m2 IV over 120 min. +/- 30 Day 1 May give oxaliplatin and leucovorin concurrently
Injury, poisoning and procedural complications Post-operative bleeding	20.0% 1/5 • Number of events 1 • 2 years
Hepatobiliary disorders biliary obstruction	20.0% 1/5 • Number of events 1 • 2 years

Other adverse events

Adverse event data not reported

Additional Information

Ingrid Block - CTO Directo

University of Oklahoma

Phone: 405-271-8777

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place