Neoplasms

All Conditions

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma

Pancreatic Neoplasms

Neuroendocrine Tumors

Carcinoma, Neuroendocrine

Carcinoma, Islet Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Adenocarcinoma

Pancreatic Cancer

Neuroendocrine Tumor

Gastro-enteropancreatic Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Gastrointestinal Agents

Irinotecan

Leucovorin

Fluorouracil

Oxaliplatin

Lenograstim

Folfirinox

Pancrelipase

Pancreatin

Adjuvants, Immunologic

Immunologic Factors

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.

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 every 2 weeks.

FOLFIRINOX

The use of G-CSF will not be mandatory as primary prophylaxis, but will be allowed at investigators' discretion. If febrile neutropenia occurs, than the use of G-CSF will be mandatory after each following cycle of treatment.

Granulocyte colony-stimulating factor (G-CSF)

Jonathan Strosberg, M.D.

The purpose of this study is evaluate the efficacy and safety of FOLFIRINOX in patients with gastroenteropancreatic high-grade neuroendocrine carcinomas.

This is a prospective Phase II open-label trial, stratifying gastroenteropancreatic high grade neuroendocrine carcinomas participants equally into two cohorts (first-line versus beyond first-line).

FOLFIRINOX in Metastatic High Grade Gastroenteropancreatic Neuroendocrine Carcinomas

Phase II Trial of FOLFIRINOX in Metastatic High Grade Gastroenteropancreatic Neuroendocrine Carcinomas

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).

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.

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).

H. Lee Moffitt Cancer Center and Research Institute

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.

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. Participants will receive up to 12 cycles during the study. Additional cycles will be determined per investigators' discretion.

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Study terminated early due to inability to accrue, leading to small number of participants analyzed.

Jonathan Strosberg, MD

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

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

Spots Global Cancer Trial Database for FOLFIRINOX in Metastatic High Grade Gastroenteropancreatic Neuroendocrine Carcinomas

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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