Neoadjuvant FOLFIRINOX Regimen in Patients With Non-metastatic Pancrease Cancer

Baylor Scott and White Health (BSWH)

Status: Unknown

Conditions: Localized Pancreas Cancer; Pancreas Cancer; Non-metastatic Pancreas Cancer

Treatments: Drug: FOLFIRINOX Regimen

Study type: Interventional

Funder types: Other

Identifiers

NCT01771146

012-180

Details and patient eligibility

About

A prospective evaluation of neoadjuvant FOLFIRINOX regimen in patients with non-metastatic pancreas cancer (Baylor University Medical Center and Texas Oncology Experience)

Full description

Patients with pancreas cancer will be enrolled and treated with a planned course of 6 cycles (3 months) of chemotherapy with FOLFIRINOX prior to undergoing surgical resection.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years of age or older
• Male or non-pregnant and non-lactating female
• Histologically or cytologically confirmed adenocarcinoma of pancreas
• Patients must have satisfactory blood counts and blood chemistry levels at baseline (refer to Appendix 2, Study Laboratory References Range).
• Patient has Eastern Cooperative Oncology Group(ECOG) Performance Status 0 to 1 (refer to Appendix 7):
• 0 - Asymptomatic (Fully active, able to carry on all predisease activities without restriction)
• 1 - Symptomatic but completely ambulatory (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature. For example, light housework, office work)
• Signed study consent form

Exclusion criteria

• <18 years of age
• Pregnant or lactating female
• Patient has islet cell neoplasms
• Patient has known brain metastases
• Patient has metastatic disease
• Active secondary malignancies
• Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
• Known infection with hepatitis B, hepatitis C, or cirrhosis
• Major surgery or vascular device placement (excluding ports for IV medication/chemotherapy) within 2 weeks prior to Day 1 of treatment in study
• Prior chemotherapy or radiation for pancreatic cancer
• History of allergy or hypersensitivity to the study drugs
• Patient is enrolled in any outside (outside Baylor University Medical Center or Texas Oncology) clinical protocol or investigational trial
• Significant cardiac disease as defined as New York Heart Association (NYHA) classification III or IV, uncontrolled congestive heart failure (CHF), or prior myocardial infarction (MI) last 6-months
• Any prior gastrointestinal (GI) disease or history of prior pelvic or abdominal radiation which in the opinion of the investigator may place the patient at increased risk
• Peripheral sensory neuropathy ≥ to grade 2 at baseline
• Significant co-morbidities deemed by investigator as unsuitable for participation/enrollment
• Study consent form not signed

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Neoadjuvant FOLFIRINOX Regimen

Other group

Description:

Single arm, treated with neoadjuvant FOLFIRINOX prior to surgical resection

Treatment:

Drug: FOLFIRINOX Regimen