Clinical trial NCT01677988: Neoadjuvant Folfirinox Followed by Capecitabine and Limited Field Radiation for Localized Pancreatic Head Adenocarcinoma
Official title: Phase II Study of Neoadjuvant Folfirinox Chemotherapy Followed by Capecitabine With Concurrent Limited Field Radiation Therapy in Patients With Localized Pancreatic Head Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Adenocarcinoma of Head of Pancreas
Keywords: NEOADJUVANT FOLFIRINOX CHEMOTHERAPY
LOCALIZED PANCREATIC HEAD ADENOCARCINOMA
RADIATION THERAPY
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2012-09-03
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is for subjects with adenocarcinoma of the pancreas. The purpose of this research study is to determine the safety and effectiveness of modified Folfirinox and radiation therapy as treatment for adenocarcinoma (cancer) of the pancreas before surgery. Screening tests will be done to determine if subjects are eligible for participation in this study. If subjects are eligible to participate and agree to participate they will begin chemotherapy. After 3 cycles of chemotherapy, subjects will begin chemoradiation. Within 4 to 8 weeks of completing radiation therapy, subjects will have surgery. There will also be post-treatment and follow-up evaluations. Subjects will be followed for every 3 months for 3 years after their initial registration.


Eligibility criteria: Inclusion Criteria:

* Patient has histologically or cytologically confirmed borderline resectable adenocarcinoma of the pancreas. Patients with islet cell or other neuroendocrine neoplasms are excluded.
* Borderline resectable disease as outlined in the protocol
* ≥ 18 years of age.
* Male or non-pregnant and non-lactating female. If a female patient is of childbearing potential, she must have a negative serum pregnancy test (β hCG) documented within 72 hours of the first administration of study drug.
* If sexually active, the patient must agree to use contraception considered adequate and appropriate by the Investigator.
* Patient must not have received prior chemotherapy or radiation for pancreatic cancer and no exposure to systemic chemotherapy.
* Patient have acceptable blood counts, chemistries \& coagulation at baseline as outlined in the protocol
* Patient has an ECOG performance status PS 0-1.
* Patient has been informed about the nature of the study and has agreed to participate in the study and signed the Informed Consent Form prior to participation in any study-related activities.
* Endoscopic ultrasound (EUS) with FNA for cytology.
* Patients should not have any evidence of active or uncontrolled infection requiring treatment with antibiotics.

Exclusion Criteria:

* Patient has localized resectable, locally advanced unresectable or advanced metastatic disease. Patients with adenocarcinoma of the pancreatic body or tail are ineligible.
* Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
* Patient has known infection with HIV.
* Patient has undergone major surgery, other than diagnostic surgery (i.e.surgery done to obtain a biopsy for diagnosis without removal of an organ), within 4 weeks prior to Day 1 of treatment in this study.
* Prior chemotherapy, immunotherapy or radiation for pancreatic cancer.
* Patient has a history of allergy or hypersensitivity to the study drugs.
* Patient has serious medical risk factors involving any of the major organ systems such that the Investigator considers it unsafe for the patient to receive chemotherapy and/or radiation therapy.
* Patients must not require chronic use of immunosuppressive agents (e.g. methotrexate, cyclosporine).
* No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for five years.
* Patients must not have clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) \< 1 year before randomization.
* Patients must not have a history of any medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risks associated with the study participation or investigational product(s) administration or may interfere with the interpretation of the results.
* Patient is unwilling or unable to comply with study procedures.
* Patient is enrolled in any other therapeutic clinical protocol or investigational trial.
* Patients aged \> 70

Primary outcomes:
measure: Estimate the R0/R1 Resection Rate
timeFrame: at time of surgery
Secondary outcomes:
measure: Radiographic Tumor Response
timeFrame: From enrollment to Surgery
measure: Histopathologic Tumor Response
timeFrame: at the time of surgery
measure: Time to Recurrence:
timeFrame: 2 years
measure: Overall Survival:
timeFrame: 2 years
Other outcomes:
measure: Feasibility Objective
timeFrame: From enrollment to end of chemotherapy part of the study
measure: CTC Analysis
timeFrame: End of study
measure: CTC Expression
timeFrame: 2 years
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Paul E. O'Brien, MD
role: PRINCIPAL_INVESTIGATOR
References: