Trial Outcomes & Findings for A Pilot Study of Pre- and Post-surgery Chemotherapy With mFOLFIRINOX in Localized, Resectable Pancreatic Adenocarcinoma (NCT NCT01660711)

Results Overview

The percentage of participants able to complete the full course of preoperative chemotherapy and undergo a resection. This will be the primary determinant of success for this pilot study. - Early withdrawals due to toxicity, disease progression, or intercurrent illness will be considered failures.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

22 participants

Primary outcome timeframe

Following completion of all planned therapy, an expected average of 4 months

Results posted on

2021-11-08

Participant Flow

Participant milestones

Participant milestones
Measure	FOLFIRINOX Chemotherapy 5FU 2400 mg/m2 IV over 48 hours Irinotecan 180 mg/m2 IV day 1 Oxaliplatin 85 mg/m2 IV day 1 Leucovorin 400 mg/m2 IV day 1 Cycles administered every 14 days for 4 cycles before and 4 cycles after surgery. 5 Fluorouracil: 2400 mg/m2 by continuous intravenous infusion over 46 hours Leucovorin: 400 mg/m2 by IV infusion over 2 hours Irinotecan: 180 mg/m² IV infusion on Day 1 over 90-120 minutes (infusion via a Y connector during the infusion of leucovorin) Oxaliplatin: 85 mg/m² IV infusion on Day 1 over 2 hours
Overall Study STARTED	22
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	FOLFIRINOX Chemotherapy 5FU 2400 mg/m2 IV over 48 hours Irinotecan 180 mg/m2 IV day 1 Oxaliplatin 85 mg/m2 IV day 1 Leucovorin 400 mg/m2 IV day 1 Cycles administered every 14 days for 4 cycles before and 4 cycles after surgery. 5 Fluorouracil: 2400 mg/m2 by continuous intravenous infusion over 46 hours Leucovorin: 400 mg/m2 by IV infusion over 2 hours Irinotecan: 180 mg/m² IV infusion on Day 1 over 90-120 minutes (infusion via a Y connector during the infusion of leucovorin) Oxaliplatin: 85 mg/m² IV infusion on Day 1 over 2 hours
Overall Study Adverse Event	7
Overall Study Withdrawal by Subject	1

Baseline Characteristics

1 person registered was ineligible and did not participate.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FOLFIRINOX Chemotherapy n=22 Participants All participants.
Age, Categorical <=18 years	0 Participants n=22 Participants • 1 person registered was ineligible and did not participate.
Age, Categorical Between 18 and 65 years	17 Participants n=22 Participants • 1 person registered was ineligible and did not participate.
Age, Categorical >=65 years	5 Participants n=22 Participants • 1 person registered was ineligible and did not participate.
Sex: Female, Male Female	9 Participants n=22 Participants
Sex: Female, Male Male	13 Participants n=22 Participants
Region of Enrollment United States	22 participants n=22 Participants

PRIMARY outcome

Timeframe: Following completion of all planned therapy, an expected average of 4 months

The percentage of participants able to complete the full course of preoperative chemotherapy and undergo a resection. This will be the primary determinant of success for this pilot study. - Early withdrawals due to toxicity, disease progression, or intercurrent illness will be considered failures.

Outcome measures

Outcome measures
Measure	FOLFIRINOX Chemotherapy n=22 Participants 5FU 2400 mg/m2 IV over 48 hours Irinotecan 180 mg/m2 IV day 1 Oxaliplatin 85 mg/m2 IV day 1 Leucovorin 400 mg/m2 IV day 1 Cycles administered every 14 days for 4 cycles before and 4 cycles after surgery. 5 Fluorouracil: 2400 mg/m2 by continuous intravenous infusion over 46 hours Leucovorin: 400 mg/m2 by IV infusion over 2 hours Irinotecan: 180 mg/m² IV infusion on Day 1 over 90-120 minutes (infusion via a Y connector during the infusion of leucovorin) Oxaliplatin: 85 mg/m² IV infusion on Day 1 over 2 hours
Percentage Able to Complete Full Course of Preoperative Chemotherapy	22 Participants

SECONDARY outcome

Timeframe: On completion of all planned therapy, an expected average of 8 months

The percentage of participants able to complete the full course of therapy, including preoperative chemotherapy, surgical resection and postoperative chemotherapy.

Outcome measures

Outcome measures
Measure	FOLFIRINOX Chemotherapy n=22 Participants 5FU 2400 mg/m2 IV over 48 hours Irinotecan 180 mg/m2 IV day 1 Oxaliplatin 85 mg/m2 IV day 1 Leucovorin 400 mg/m2 IV day 1 Cycles administered every 14 days for 4 cycles before and 4 cycles after surgery. 5 Fluorouracil: 2400 mg/m2 by continuous intravenous infusion over 46 hours Leucovorin: 400 mg/m2 by IV infusion over 2 hours Irinotecan: 180 mg/m² IV infusion on Day 1 over 90-120 minutes (infusion via a Y connector during the infusion of leucovorin) Oxaliplatin: 85 mg/m² IV infusion on Day 1 over 2 hours
Percentage Able to Complete Full Course of Therapy	14 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

Treatment related toxicity and other adverse events (AEs) during Toxicity of preoperative and postoperative therapy and the safety of this approach.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months

Assessment of the percentage of patients able to have an R0 resection following preoperative chemotherapy.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 5 years

Assessment of progression-free survival and overall survival from the start of study treatment.

Outcome measures

Outcome data not reported

Adverse Events

FOLFIRINOX Chemotherapy

Serious events: 14 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	FOLFIRINOX Chemotherapy n=22 participants at risk FOLFIRINOX chemotherapy in all participants.
Gastrointestinal disorders Diarrhea	18.2% 4/22 • Number of events 4 • 2 years
Blood and lymphatic system disorders neutropenia	4.5% 1/22 • 2 years
Gastrointestinal disorders anorexia	22.7% 5/22 • 2 years
Endocrine disorders Hyperglycemia	9.1% 2/22 • 2 years
Renal and urinary disorders Hypokalemia	4.5% 1/22 • 2 years
General disorders Fatigue	13.6% 3/22 • 2 years
Nervous system disorders peripheral neuropathy	13.6% 3/22 • 2 years

Other adverse events

Adverse event data not reported

Additional Information

Dr Robert Marsh

NorthShore University/University of Chicago

Phone: 847-5702112

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place