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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01771146
Other study ID # 012-180
Secondary ID
Status Active, not recruiting
Phase N/A
First received January 8, 2013
Last updated January 30, 2017
Start date October 2012
Est. completion date September 2020

Study information

Verified date January 2017
Source Baylor Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 30
Est. completion date September 2020
Est. primary completion date September 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Drug:
FOLFIRINOX Regimen
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

Locations

Country Name City State
United States Baylor University Medical Center - Texas Oncology Dallas Texas

Sponsors (1)

Lead Sponsor Collaborator
Baylor Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 • The length of time from diagnosis (enrollment) to death Up to 5 years
Secondary • Overall Survival rate defined by the % of people who are alive for a certain period of time after diagnosis Up to 5 years
Secondary • R0 resection as defined as microscopically negative margins Up to 5 years
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