FOLFIRINOX in Metastatic High Grade Gastroenteropancreatic Neuroendocrine Carcinomas

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03042780
• Other study ID #: MCC-18675
• Status: Terminated
• Phase: Phase 2
• Start date: February 1, 2017
• Est. completion date: September 7, 2018

Study information

• Verified date: November 2020
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: September 7, 2018
• Est. primary completion date: January 3, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically or cytologically confirmed neuroendocrine carcinoma of the gastrointestinal (GI) tract. Potential participants with unknown origin for the neuroendocrine carcinoma in which a gastroenteropancreatic origin is suspected (per pathologist or investigator discretion) will be eligible for the study.
• Tumors must have a Ki-67 index greater than 20% and/or >20 mitotic figures/10 high-power fields.
• Must have metastatic disease.
• Must measurable disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
• Any line of treatment (first line versus beyond first line).
• Age >18 years.
• Life expectancy of greater than 12 weeks.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
• Must have adequate organ and marrow function.
• Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

• Have had chemotherapy or radiotherapy within 3 weeks prior to entering the study.
• Receiving any other investigational agents.
• Untreated brain or meningeal metastases.
• Prior treatment with 5-fluorouracil (5-FU), irinotecan or oxaliplatin.
• Pre-treatment peripheral neuropathy greater than grade 1 per the CTCAE, version 4.0.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• A secondary primary cancer (excluding baso/squamous cell carcinoma of skin) within 1 year.
• Active viral hepatitis or autoimmune hepatitis. The work-up to confirm active hepatitis or autoimmune hepatitis will only be done if clinical suspicion based on investigator discretion.
• Potential participants with childbearing potential who are not willing to use adequate contraception precautions during the study and for 3 months after stopping study chemotherapy.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Islet Cell
• Carcinoma, Neuroendocrine
• Gastro-enteropancreatic Neuroendocrine Tumor
• Islet Cell Carcinoma
• Neuroendocrine Carcinomas of Pancreas
• Neuroendocrine Tumors
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• 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 every 2 weeks.
• Granulocyte colony-stimulating factor (G-CSF)
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.

Locations

Country	Name	City	State
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Treatment Related Morbidity	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).	Up to 36 months
Primary	Objective Radiographic Response Rate (ORR)	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.	Up to 36 months
Secondary	Progression Free Survival (PFS)	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).	Up to 36 months

External Links

•   Moffitt Cancer Center Clinical Trials website