Adenocarcinoma of Pancreas
Conditions
Keywords
Locally advanced unresectable adenocarcinoma of pancreas, Borderline resectable adenocarcinoma of pancreas
Brief summary
The prognosis of patients with locally advanced unresectable pancreatic cancer is poor, and the median survival is less than 1 year. FOLFIRINOX therapy, which induces tumor downstaging sufficient to allow surgical resection, could improve the overall survival of patients with locally advanced pancreatic cancer. Based on the FOLFIRINOX regimen for advanced pancreatic cancer, a phase II study of this regimen in patients with locally advanced unresectable and borderline pancreatic cancer is planned to determine the rate of conversion to operability.
Interventions
DRUGIrinotecan, Oxaliplatin, Leucovorin, 5-FU
5-FU 2400 mg/m2 IV continuous infusion for 46-48 hours Days 1-3 for 2 weeks 5-FU 400 mg/m2 IV Bolus Day 1 Oxaliplatin 85 mg/m2 IV over 120min +/-30 min. Day 1 Irinotecan 180 mg/m2 IV to run over 90 min +/- 30 min Day 1 Leucovorin (Before bolus 5-FU) 400 mg/m2 IV over 120 min. +/- 30 Day 1 May give oxaliplatin and leucovorin concurrently
Sponsors
University of Oklahoma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically confirmed locally advanced unresectable or borderline resectable adenocarcinoma of pancreas * Patients must have measurable disease as defined by RECIST 1.1 RECIST evaluations must have occurred within 4 weeks prior to study entry * No evidence of hepatic or pulmonary metastatic disease by CT or CT/PET scans * Male or non-pregnant and non-lactating female age \> or equal to 18 years and \< or equal to 70 years of age * Patient must have received no prior therapy for the treatment of locally advanced unresectable or borderline resectable pancreatic cancer * Patients must have adequate blood counts at baseline and blood chemistry levels * Patient has ECOG Performance Status 0 to 1
Exclusion criteria
* Patients with islet cell neoplasms excluded * Patients with known brain metastases * Therapeutic Coumadin for a history of pulmonary emboli or deep vein thrombosis (DVT) * Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy * Known infection with HIV, hepatitis B or hepatitis C * Major surgery or vascular device placement within 4 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 other clinical protocol or investigational trial * Metastatic disease on radiological staging * Prior malignancy within last 3 years * Significant cardiac disease * Any prior gastrointestinal (GI) disease or history of prior pelvic or abdominal radiation in which in opinion of the investigator may place the patient at increased risk * peripheral sensory neuropathy \> or equal to grade 2 at baseline
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To Estimate, Among Patients With Locally Advanced Unresectable and Borderline Resectable Pancreatic Cancer, the Proportion in Whom R0 Resection is Achieved After Neoadjuvant Therapy. | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of Patients Whose Pancreatic Cancer is Operable (Resulting in R0 or R1 Resection) Following Induction Therapy. | 2 years |
| Response Rate (Either Complete Response (CR) or Partial Response (PR) by RECIST 1.1 Criteria) | 2 years |
| Overall Survival | 2 years |
| Number of Participants Who Experienced Toxicity | 2 years |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| FOLFIRINOX Combination of drugs (Irinotecan, Oxaliplatin, Leucovorin, and 5-Fluorouracil (5-FU)) known as FOLFIRINOX every 2 weeks for 4 treatments. At the end of 4 cycles, patients will be re-evaluated for resectability by CT scan within 28 days of the last dose of chemo. If found amendable to surgery, patient will proceed with resection, and type of resection (R0 or R1) will be recorded.
Irinotecan, Oxaliplatin, Leucovorin, 5-FU: 5-FU 2400 mg/m2 IV continuous infusion for 46-48 hours Days 1-3 for 2 weeks 5-FU 400 mg/m2 IV Bolus Day 1 Oxaliplatin 85 mg/m2 IV over 120min +/-30 min. Day 1 Irinotecan 180 mg/m2 IV to run over 90 min +/- 30 min Day 1 Leucovorin (Before bolus 5-FU) 400 mg/m2 IV over 120 min. +/- 30 Day 1 May give oxaliplatin and leucovorin concurrently | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | FOLFIRINOX |
|---|---|
| Age, Continuous | 60 years |
| Race (NIH/OMB) Race American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Race Asian | 0 Participants |
| Race (NIH/OMB) Race Black or African American | 1 Participants |
| Race (NIH/OMB) Race More than one race | 1 Participants |
| Race (NIH/OMB) Race Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Race Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) Race White | 3 Participants |
| Region of Enrollment United States | 5 Participants |
| Sex: Female, Male sex Female | 2 Participants |
| Sex: Female, Male sex Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 5 |
| serious Total, serious adverse events | 2 / 5 |
Outcome results
Primary
To Estimate, Among Patients With Locally Advanced Unresectable and Borderline Resectable Pancreatic Cancer, the Proportion in Whom R0 Resection is Achieved After Neoadjuvant Therapy.
Time frame: 2 years
Population: Data was not collected from any single study participant.
Secondary
Number of Participants Who Experienced Toxicity
Time frame: 2 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 5-FU, Leucovorin, Oxaliplatin, Irinotecan | Number of Participants Who Experienced Toxicity | 2 Participants |
Secondary
Overall Survival
Time frame: 2 years
Population: Data was not collected from any single study participant.
Secondary
Proportion of Patients Whose Pancreatic Cancer is Operable (Resulting in R0 or R1 Resection) Following Induction Therapy.
Time frame: 2 years
Population: Data was not collected from any single study participant
Secondary
Response Rate (Either Complete Response (CR) or Partial Response (PR) by RECIST 1.1 Criteria)
Time frame: 2 years
Population: Data was not collected from any single study participant.