Neoadjuvant FOLFIRINOX Regimen in Patients With Non-metastatic Pancrease Cancer

• Status: Unknown status
• Trial end date: 2020-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baylor Research Institute
• Treatments: Camptothecin; Fluorouracil; Folfirinox; Irinotecan; Leucovorin; Oxaliplatin; Pancreatin; Pancrelipase

Criteria

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