Pancreatic Adenocarcinoma
Conditions
Keywords
Patients, with, resected
Brief summary
Determine the relapse-free survival of resected pancreatic cancer patients following two novel regimens with activity in advanced disease.
Detailed description
This trial is a randomized Phase II study of FOLFIRINOX versus gemcitabine/abraxane in patients with completely resected pancreatic cancer (Stages I-III). Patients will receive eight weeks of chemotherapy, then 5-FU/radiation, then another 8 weeks.
Interventions
DRUGAbraxane
125 mg/m2 IV over 30 minutes, day 1, 8, 15
DRUGGemcitabine
1000mg/m2 IV over 30 to 100 minutes, day 1, 8, 15
DRUGFOLFIRINOX
Irinotecan 180 mg/m2 Day 1 Oxaliplatin 85 mg/m2 Day 1 5-FU 400 mg/m2 bolus with Leucovorin 200 mg/m2 over 2h, Day 1, then 5-FU 2400 mg/m2 over 46h. Four cycles, if tolerated
RADIATIONChemoradiation
Sponsors
Abramson Cancer Center at Penn Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients must have histologically or cytologically confirmed evidence of pancreatic carcinoma. * Patients must have had all gross disease resected (R0 or R1 resection, patients who underwent an R2 resection are not eligible). * Patients must have had no prior chemotherapy or radiation therapy for pancreatic cancer. * Age \> 18 years. * Patient must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. * Patients must have normal organ and marrow function measured within 2 weeks, prior to registration as follows: Absolute Neutrophil Count (ANC) \> 1,500/µL Platelets \> 100,000/µL Total bilirubin less than 2-fold upper limit of normal (ULN) Aspartate Aminotransferase (AST)/alanine aminotransferase (ALT)\<2.5X institutional upper limit of normal Creatinine clearance \> 60mL/min for patients with creatinine levels above institutional normal. * Patients must be \> 4 weeks and \< 12 weeks post-surgery at time of study registration. * Women of childbearing potential and sexually active males are strongly advised to use appropriate contraceptive measures. * Women must not be pregnant or breast-feeding.
Exclusion criteria
* Patients receiving any other investigational agents. * Patients with known metastases. * Patients with wounds that have not fully healed.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Relapse-free Survival | 20 months | In this small trial we will regard a median progression-free survival of 20 months as indicative of potential therapeutic benefit meriting additional study. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| FOLFIRINOX FOLFIRINOX: Irinotecan 180 mg/m2 Day 1 Oxaliplatin 85 mg/m2 Day 1 5-FU 400 mg/m2 bolus with Leucovorin 200 mg/m2 over 2h, Day 1, then 5-FU 2400 mg/m2 over 46h. Four cycles, if tolerated
Chemoradiation | 17 |
| Gemcitabine Gemcitabine: 1000mg/m2 IV over 30 to 100 minutes, day 1, 8, 15
Abraxane: 125 mg/m2 IV over 30 minutes, day 1, 8, 15
Chemoradiation | 15 |
| Total | 32 |
Baseline characteristics
| Characteristic | FOLFIRINOX | Gemcitabine | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 11 Participants | 8 Participants | 19 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 7 Participants | 13 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 13 Participants | 13 Participants | 26 Participants |
| Region of Enrollment United States | 17 participants | 15 participants | 32 participants |
| Sex: Female, Male Female | 10 Participants | 5 Participants | 15 Participants |
| Sex: Female, Male Male | 7 Participants | 10 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 15 |
| other Total, other adverse events | 17 / 17 | 15 / 15 |
| serious Total, serious adverse events | 4 / 17 | 6 / 15 |
Outcome results
Primary
Number of Participants With Relapse-free Survival
In this small trial we will regard a median progression-free survival of 20 months as indicative of potential therapeutic benefit meriting additional study.
Time frame: 20 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1 | Number of Participants With Relapse-free Survival | 3 Participants |
| Arm 2 | Number of Participants With Relapse-free Survival | 2 Participants |