Trial Outcomes & Findings for FOLFIRINOX in Metastatic High Grade Gastroenteropancreatic Neuroendocrine Carcinomas (NCT NCT03042780)

Last Updated: 2020-11-27

Results Overview

The primary efficacy endpoint is objective response rate as determined by radiology review, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Complete Response (CR): complete disappearance of all target lesions. Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum longest diameter. Progressive disease (PD): at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this may include the baseline sum). Stable Disease (SD): neither sufficient decrease to qualify for partial response nor sufficient increase to qualify for progressive disease.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

Up to 36 months

Results posted on

2020-11-27

Participant Flow

Participant milestones

Participant milestones
Measure	FOLFIRINOX Treatment Participants will receive modified FOLFIRINOX which consists of 85 mg/m\^2 of oxaliplatin, 400 mg/m\^2 of leucovorin over the first 2 hours, 165 mg/m\^2 of irinotecan in a 90-minute infusion on day 1, followed by a continuous, 46-hour infusion of 5-FU at a dosage of 2,400 mg/m\^2. A cycle will be repeated every 14 days. Granulocyte colony-stimulating factor (G-CSF) prophylaxis will be allowed after each cycle. Participants will undergo re-staging studies every 8 weeks. Participants will receive up to 12 cycles during the study. Additional cycles will be determined per investigators' discretion. FOLFIRINOX: The FOLFIRINOX regimen consists of oxaliplatin given as a 2-hour intravenous infusion, immediately followed by leucovorin given as a 2-hour intra-venous infusion, with the addition, after 30 minutes, of irinotecan given as a 90-minute intravenous infusion. This study treatment is immediately followed by a continuous intravenous infusion of 5-Fluorouracil (5-FU) over a 46-hour period
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

FOLFIRINOX in Metastatic High Grade Gastroenteropancreatic Neuroendocrine Carcinomas

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FOLFIRINOX Treatment n=2 Participants Participants will receive modified FOLFIRINOX which consists of 85 mg/m\^2 of oxaliplatin, 400 mg/m\^2 of leucovorin over the first 2 hours, 165 mg/m\^2 of irinotecan in a 90-minute infusion on day 1, followed by a continuous, 46-hour infusion of 5-FU at a dosage of 2,400 mg/m\^2. A cycle will be repeated every 14 days. Participants will receive up to 12 cycles during the study. Additional cycles will be determined per investigators' discretion.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=93 Participants
Age, Categorical >=65 years	1 Participants n=93 Participants
Sex: Female, Male Female	1 Participants n=93 Participants
Sex: Female, Male Male	1 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	2 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	2 participants n=93 Participants

PRIMARY outcome

Timeframe: Up to 36 months

Population: Due to low accrual, study was halted prematurely. No data, as no patients were analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 36 months

Population: No data displayed because Outcome Measure has zero total participants analyzed.

PFS: from initiation date of therapy to disease progression or death. Progressive disease (PD): at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this may include the baseline sum).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 36 months

Population: No data displayed because Outcome Measure has zero total participants analyzed.

Safety analysis will be analyzed by collecting date on treatment-related morbidity and mortality. Investigators will collect data on frequency, type and severity of all adverse events that occur on or after Cycle 1, Day 1 according to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE; Version 4.0).

Outcome measures

Outcome data not reported

Adverse Events

FOLFIRINOX Treatment

Serious events: 0 serious events

Other events: 2 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	FOLFIRINOX Treatment n=2 participants at risk Participants received modified FOLFIRINOX which consists of 85 mg/m\^2 of oxaliplatin, 400 mg/m\^2 of leucovorin over the first 2 hours, 165 mg/m\^2 of irinotecan in a 90-minute infusion on day 1, followed by a continuous, 46-hour infusion of 5-FU at a dosage of 2,400 mg/m\^2. A cycle will be repeated every 14 days. Granulocyte colony-stimulating factor (G-CSF) prophylaxis will be allowed after each cycle.
Blood and lymphatic system disorders Anemia	50.0% 1/2 • Number of events 4 • 1 year
Eye disorders Blurred Vision	50.0% 1/2 • Number of events 1 • 1 year
Gastrointestinal disorders Nausea	100.0% 2/2 • Number of events 2 • 1 year
General disorders Fatigue	50.0% 1/2 • Number of events 1 • 1 year
Infections and infestations Skin Infection	50.0% 1/2 • Number of events 1 • 1 year
Investigations Alanine aminotransferase increased	50.0% 1/2 • Number of events 7 • 1 year
Investigations Alkaline phosphatase increased	50.0% 1/2 • Number of events 4 • 1 year
Investigations Aspartate aminotransferase increased	50.0% 1/2 • Number of events 6 • 1 year
Investigations Lymphocyte count decreased	50.0% 1/2 • Number of events 1 • 1 year
Investigations Neutrophil count decreased	100.0% 2/2 • Number of events 3 • 1 year
Investigations White blood cell decreased	100.0% 2/2 • Number of events 5 • 1 year
Metabolism and nutrition disorders Hyperglycemia	50.0% 1/2 • Number of events 2 • 1 year
Metabolism and nutrition disorders Hypernatremia	50.0% 1/2 • Number of events 1 • 1 year
Metabolism and nutrition disorders Hypokalemia	50.0% 1/2 • Number of events 1 • 1 year
Musculoskeletal and connective tissue disorders Arthralgia	50.0% 1/2 • Number of events 1 • 1 year
Musculoskeletal and connective tissue disorders Back pain	50.0% 1/2 • Number of events 1 • 1 year
Gastrointestinal disorders Diarrhea	50.0% 1/2 • Number of events 1 • 1 year
Nervous system disorders Ataxia	50.0% 1/2 • Number of events 1 • 1 year

Additional Information

Jonathan Strosberg, MD

H Lee Moffitt Cancer Center and Research Institute

Phone: 813-745-7257

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place