CompletedNCT02178709Updated Apr 19, 2022Results posted

A Phase II Study of Neoadjuvant FOLFIRINOX

A Phase 2 interventional study of FOLFIRINOX in Resectable Pancreatic Ductal Adenocarcinoma, sponsored by Indiana University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-19.

Sponsored by Indiana University · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 48
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study summary

The primary objective of this study is to evaluate the rate of pathologic complete response to neoadjuvant FOLFIRINOX in patients with resectable pancreatic cancer using a tissue collection component.

Conditions studied

Resectable Pancreatic Ductal Adenocarcinoma

Browse trials for

Adenocarcinoma 2,004

Keywords

Pancreatic
Cancer
Resectable

In context

Adenocarcinoma

2,004 studies on the registry are indexed under Adenocarcinoma; 374 are open to participants now.

This study's enrollment of 48 is close to the median of 45 across 1,553 interventional studies indexed under Adenocarcinoma.

Browse Adenocarcinoma studies →

Lead sponsor

Indiana University is the lead sponsor of 958 studies on the registry; 200 are open to participants now.

Of its 142 completed or terminated interventional studies of FDA-regulated products, 112 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

≥ 18 years old at the time of informed consent
Able to provide written informed consent and HIPAA authorization
ECOG performance status of 0 or 1
Patient must be eligible for abdominal surgery
Histologically confirmed adenocarcinoma of the pancreas that has been documented to be resectable by standardized radiographic criteria by a pancreatic surgeon
Patients must to have tumor tissue collected prior to enrolling on this trial. Up to 10 patients will be accepted with no pre-treatment research tissue collection or tissue collection from an outside institution.
a.If the tissue is from an outside institution, it must be reviewed at Indiana University Health Pathology Department if a biopsy was performed outside of this institution.
Women of childbearing potential definition (WOCBP) must have a negative serum or urine pregnancy test performed within 14 days prior to initiation of FOLFIRINOX.
Any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) is classified as WOCBP if she meets the following criteria:
1. Has not undergone a hysterectomy or bilateral oophorectomy; or
2. Has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
WOCBP and men must agree to use adequate contraception prior, to study entry, for the duration of study participation, and 8 weeks after the end of treatment.
Patients must have adequate organ function as defined by the following laboratory values at study entry:
1. Hemoglobin ≥ 9 g/dL (transfusions are acceptable)
2. ANC ≥ 1.5 x 109/L
3. Platelets ≥ 100 x 109/L
4. Creatinine ≤ 1.5 x ULN, or creatinine clearance ≥ 50 mL/min (estimated by Cockcroft-Gault or measured)
5. Total bilirubin ≤ 1.5 x ULN
6. AST/ALT ≤ 3 x ULN

Exclusion criteria

Exclusion Criteria:

Prior therapy for pancreatic adenocarcinoma
Other malignancies within the past 3 years except for the following: adequately treated cervical or vulvar carcinoma in situ, treated basal cell or squamous carcinoma of the skin, superficial bladder tumors (Ta, Tis \& T1), ductal carcinoma in situ (DCIS) of the breast and low grade prostate cancer. Any cancer curatively treated >3 years prior to entry with no clinical evidence of recurrence is permitted.
Hypersensitivity to 5FU, oxaliplatin (or other platinum agents), irinotecan (or to their excipients).
Participation in any investigational drug study within 4 weeks preceding the start of study treatment. Patients are not permitted to participate in another investigational drug study while being treated on this protocol.
Inability to receive a port or PICC line.
History of or suspected Gilbert's Disease (testing not required if presence is not suspected).
Baseline peripheral neuropathy/paresthesia grade ≥ 1.
Active hepatitis B, unless patient has been on antiviral agents for at least 2 months (baseline testing not required).
Active clinically serious infections (> grade 2).
Major surgery or significant traumatic injury within 8 weeks of first study drug. A core pancreatic or liver biopsy does not preclude the patient from the study.
Unable or unwilling to discontinue use of ketoconazole or St John's wort. Use of phenytoin, carbamazepine, phenobarbital, rifampin and rifabutin is discouraged, but not contraindicated. If patients require phenytoin, carbamazepine or phenobarbital monitoring of drug levels is suggested during the study.
Pregnant or lactating women.
Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 48 participants (actual)

Study arms

Experimental
FOLFIRINOX
FOLFIRINOX consists of the following combination of drugs: 1. Oxaliplatin, 85 mg/m2, IV over 2 hours prior to irinotecan, administered on days 1 and 15 of each 28 day cycle 2. Leucovorin, 400 mg/m2, IV over 2 hours with irinotecan, administered on days 1 and 15 of each 28 day cycle 3. Irinotecan, 180 mg/m2, IV over 90 minutes with leucovorin, administered on days 1 and 15 of each 28 day cycle 4. 5 FU, 400 mg/m2, IV bolus over 2 minutes after irinotecan, administered on days 1 and 15 of each 28 day cycle. 5. 5FU, 2400 mg/m2, IV infusion over 46 hours after 5FU bolus injection, administered on days 1 and 15 of each 28 day cycle.
Drug: FOLFIRINOX

Interventions

DrugFOLFIRINOX
FOLFIRINOX consists of the following combination of drugs: 1. Oxaliplatin, 85 mg/m2, IV over 2 hours prior to irinotecan, administered on days 1 and 15 of each 28 day cycle 2. Leucovorin, 400 mg/m2, IV over 2 hours with irinotecan, administered on days 1 and 15 of each 28 day cycle 3. Irinotecan, 180 mg/m2, IV over 90 minutes with leucovorin, administered on days 1 and 15 of each 28 day cycle 4.5 FU, 400 mg/m2, IV bolus over 2 minutes after irinotecan, administered on days 1 and 15 of each 28 day cycle. 5.5FU, 2400 mg/m2, IV infusion over 46 hours after 5FU bolus injection, administered on days 1 and 15 of each 28 day cycle.
Also known as: Oxaliplatin (Eloxatin), Leucovorin, Irinotecan (Camptosar), 5 FU (Adrucil)

What researchers measure

Primary outcomes

Percentage of Patients With Pathologic Complete Response
Pathologic complete response was evaluated using MRI or CT and Evan's criteria for pathologic response following neoadjuvant therapy: I: \<10% to no tumor cells destroyed IIa: 10-50% of tumor cells destroyed IIb: 50-90% of tumor cells destroyed III: \>90% of tumor cells destroyed IIIM: sizable pools of cellular mucin IV: No viable tumor cells (complete pathologic response) IVM: Acellular pools of mucin
Time frame: Up to 4 months

Secondary outcomes

Number of Patients With Treatment-Related Adverse Events Grade 3 or Above
Number of unique patients who had a treatment-related (possible, probable, or definite) adverse event with grade 3 or greater using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Time frame: Every 15 days for approximately 6 months
Percentage of Patients Who Successfully Underwent Surgery After Neoadjuvant FOLFIRINOX
The percentage of patients who successfully underwent surgery after neoadjuvant FOLFIRINOX and its 95% confidence interval will be provided.
Time frame: Up to 4 months
Rate of R0 Resection
The percentage of patients with a final margin status of R0 after resection of their primary tumor and its 95% confidence interval will be provided. R0 resection indicates a microscopically margin-negative resection, in which no cancer cells seen microscopically at the primary tumor site.
Time frame: Up to 4 months
Disease Free Survival
Disease free survival is defined as the time from on study date to evidence of tumor recurrence or death from any cause. Patients who remained alive and disease free were censored at their date of last disease evaluation.
Time frame: Up to 3 years
Overall Survival
Overall survival was defined as the time from on study date to death due to any cause. Patients who remained alive were censored at their last known alive date. The Kaplan-Meier method was used to determine the median and 95% confidence interval.
Time frame: Up to 4 years
Objective Response Rate (Percentage of Patients With Complete Response or Partial Response)
Measured by RECIST v1.1 Complete response: Disappearance of all target lesions Partial response: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter The percentage of patients with objective response and its 95% confidence interval will be provided.
Time frame: Up to 4 months
Disease Control Rate (Percentage of Patients With Complete Response, Partial Response, or Stable Disease)
Measured by RECIST v1.1 Complete response: Disappearance of all target lesions Partial response: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter Stable disease: Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started The percentage of patients with objective response and its 95% confidence interval will be provided.
Time frame: Up to 4 months

Results

Posted Jan 31, 2020

Participant flow

Participant flow — Overall Study
Milestone	FOLFIRINOX
Started	48
Completed	32
Not completed	16
Withdrew: Adverse event	5
Withdrew: Death	2
Withdrew: Withdrawal by subject	2
Withdrew: Physician decision	2
Withdrew: Disease progression	5

Outcome measures

PrimaryPercentage of Patients With Pathologic Complete Response

Pathologic complete response was evaluated using MRI or CT and Evan's criteria for pathologic response following neoadjuvant therapy: I: \<10% to no tumor cells destroyed IIa: 10-50% of tumor cells destroyed IIb: 50-90% of tumor cells destroyed III: \>90% of tumor cells destroyed IIIM: sizable pools of cellular mucin IV: No viable tumor cells (complete pathologic response) IVM: Acellular pools of mucin

Time frame:: Up to 4 months
Reported as:: Number · percentage of participants

Percentage of Patients With Pathologic Complete Response
percentage of participants	FOLFIRINOX
Percentage of Patients With Pathologic Complete Response	0 (0 to 0)

SecondaryNumber of Patients With Treatment-Related Adverse Events Grade 3 or Above

Number of unique patients who had a treatment-related (possible, probable, or definite) adverse event with grade 3 or greater using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

Time frame:: Every 15 days for approximately 6 months
Reported as:: Count of participants · Participants

Number of Patients With Treatment-Related Adverse Events Grade 3 or Above
Participants	FOLFIRINOX
Number of Patients With Treatment-Related Adverse Events Grade 3 or Above	14

SecondaryPercentage of Patients Who Successfully Underwent Surgery After Neoadjuvant FOLFIRINOX

The percentage of patients who successfully underwent surgery after neoadjuvant FOLFIRINOX and its 95% confidence interval will be provided.

Time frame:: Up to 4 months
Reported as:: Number · percentage of participants

Percentage of Patients Who Successfully Underwent Surgery After Neoadjuvant FOLFIRINOX
percentage of participants	FOLFIRINOX
Percentage of Patients Who Successfully Underwent Surgery After Neoadjuvant FOLFIRINOX	76.7 (64.1 to 89.4)

SecondaryRate of R0 Resection

The percentage of patients with a final margin status of R0 after resection of their primary tumor and its 95% confidence interval will be provided. R0 resection indicates a microscopically margin-negative resection, in which no cancer cells seen microscopically at the primary tumor site.

Time frame:: Up to 4 months
Reported as:: Number · percentage of participants

Rate of R0 Resection
percentage of participants	FOLFIRINOX
Rate of R0 Resection	75.8 (61.1 to 90.4)

SecondaryDisease Free Survival

Disease free survival is defined as the time from on study date to evidence of tumor recurrence or death from any cause. Patients who remained alive and disease free were censored at their date of last disease evaluation.

Time frame:: Up to 3 years
Reported as:: Median · months

Disease Free Survival
months	FOLFIRINOX
Disease Free Survival	8.6 (5.1 to 13.4)

SecondaryOverall Survival

Overall survival was defined as the time from on study date to death due to any cause. Patients who remained alive were censored at their last known alive date. The Kaplan-Meier method was used to determine the median and 95% confidence interval.

Time frame:: Up to 4 years
Reported as:: Median · months

Overall Survival
months	FOLFIRINOX
Overall Survival	15.7 (9.1 to 21.7)

SecondaryObjective Response Rate (Percentage of Patients With Complete Response or Partial Response)

Time frame:: Up to 4 months
Reported as:: Number · percentage of participants

Objective Response Rate (Percentage of Patients With Complete Response or Partial Response)
percentage of participants	FOLFIRINOX
Objective Response Rate (Percentage of Patients With Complete Response or Partial Response)	17.7 (4.8 to 30.5)

SecondaryDisease Control Rate (Percentage of Patients With Complete Response, Partial Response, or Stable Disease)

Measured by RECIST v1.1 Complete response: Disappearance of all target lesions Partial response: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter Stable disease: Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started The percentage of patients with objective response and its 95% confidence interval will be provided.

Time frame:: Up to 4 months
Reported as:: Number · percentage of participants

Disease Control Rate (Percentage of Patients With Complete Response, Partial Response, or Stable Disease)
percentage of participants	FOLFIRINOX
Disease Control Rate (Percentage of Patients With Complete Response, Partial Response, or Stable Disease)	88.2 (77.4 to 99.1)

Adverse events

Collected over Up to 6 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
FOLFIRINOX	35/48 (72.9%)	15/48 (31.3%)	42/48 (87.5%)

Most frequent serious events

Showing 10 of 21

Most frequent serious events
Event	FOLFIRINOX
DiarrheaGastrointestinal disorders	3/48
NauseaGastrointestinal disorders	3/48
VomitingGastrointestinal disorders	3/48
FeverGeneral disorders	3/48
Febrile neutropeniaBlood and lymphatic system disorders	2/48
Death NOSGeneral disorders	2/48
Cardiac disorders - Other, specifyCardiac disorders	1/48
Pericardial effusionCardiac disorders	1/48
Abdominal painGastrointestinal disorders	1/48
Mucositis oralGastrointestinal disorders	1/48

Most frequent other events

Showing 10 of 13

Most frequent other events
Event	FOLFIRINOX
FatigueGeneral disorders	29/48
DiarrheaGastrointestinal disorders	23/48
NauseaGastrointestinal disorders	21/48
Peripheral sensory neuropathyNervous system disorders	16/48
VomitingGastrointestinal disorders	10/48
AnorexiaMetabolism and nutrition disorders	10/48
HypokalemiaMetabolism and nutrition disorders	9/48
Mucositis oralGastrointestinal disorders	5/48
ConstipationGastrointestinal disorders	4/48
Abdominal painGastrointestinal disorders	3/48

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	FOLFIRINOX
<=18 years	0
Between 18 and 65 years	22
>=65 years	26

Age, Continuous
Age, Continuous(years)	FOLFIRINOX
Mean	62.9 ± 9.19

Sex: Female, Male
Sex: Female, Male(Participants)	FOLFIRINOX
Female	18
Male	30

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	FOLFIRINOX
Hispanic or Latino	0
Not Hispanic or Latino	47
Unknown or Not Reported	1

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	FOLFIRINOX
American Indian or Alaska Native	1
Asian	1
Native Hawaiian or Other Pacific Islander	0
Black or African American	3
White	43
More than one race	0
Unknown or Not Reported	0

Study locations

1 site

Indiana University Simon Cancer Center
Indianapolis, Indiana 46202, United States

References and documents

Study documents

Protocol and statistical analysis plan · Oct 2, 2019

Documents are hosted by the registry — open the source record to download them.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 19, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02178709
Lead sponsor: Indiana University
Responsible party: Anita Turk (Assistant Professor of Clinical Medicine, Indiana University) — Principal investigator
First posted: Jul 1, 2014
Start date: Jun 3, 2014
Primary completion: Feb 14, 2018
Completion: Oct 28, 2019
Results posted: Jan 31, 2020
Last update: Apr 19, 2022

Study contacts

Michael House, M.D.

principal investigator · Indiana University

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Adenocarcinoma→

Other studies from this sponsor

Indiana University

Start the discussion