Pancreas Cancer, Localized Pancreas Cancer, Non-metastatic Pancreas Cancer
Conditions
Keywords
Non-metastatic Pancreas Cancer, Pancreatic Cancer, Cancer of Pancreas, Adenocarcinoma of Pancreas, Neoadjuvant
Brief summary
A prospective evaluation of neoadjuvant FOLFIRINOX regimen in patients with non-metastatic pancreas cancer (Baylor University Medical Center and Texas Oncology Experience)
Detailed 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.
Interventions
6 cycles of FOLFIRINOX prior to surgical resection: Eloxatin® (Oxaliplatin) 85 mg per square meter 2-hour IV infusion Camptosar® (Irinotecan Hydrochloride) 180 mg per square meter 90-minute IV infusion via Y-connector adrucil (Fluorouracil; 5-FU)2400 mg per square meter 46-hour IV infusion
Sponsors
Baylor Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival (PFS) as defined by the length of time that a patient survives without any signs or symptoms of that cancer or any other type of cancer | Up to 5 years |
Secondary
| Measure | Time frame |
|---|---|
| • The length of time from diagnosis (enrollment) to death | Up to 5 years |
| • Overall Survival rate defined by the % of people who are alive for a certain period of time after diagnosis | Up to 5 years |
| • R0 resection as defined as microscopically negative margins | Up to 5 years |
Countries
United States
Outcome results
None listed