Pancreatic Cancer
Conditions
Keywords
Pancreatic Cancer, Adjuvant, Pancreas, Resected, Invasive adenocarcinoma, adenosquamous cancer, Intraductal papillary mucinous neoplasm
Brief summary
The investigators preliminary data suggests that FOLFOX-A may have equal or superior activity as compared to FOLFIRINOX and appears to be better tolerated. Therefore, FOLFOX-A may be a better regimen in the adjuvant setting for patients with resected pancreatic cancer. This protocol will obtain preliminary data on safety and disease-free and overall survival following administration of FOLFOX-A for patients with resected pancreatic cancer.
Detailed description
See summary above
Interventions
DRUGFOLFOXA
Abraxane: 150mg/m2 IV over 30 minutes, day 1 (administered first) every 14 days. Oxaliplatin: 85mg/m2, IV over 2 hours, day 1 every 14 days Leucovorin: 400mg/m2, IV over 2 hours, day 1 every 14 days 5-FU infusion:1200mg/m2/day, as a continuous IV infusion over 2 days, day 1 and day 2 (for a total dose of 2400mg/m2 over 46 hours.)
Sponsors
Brown University
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
* Histologic proof of primary pancreas invasive adenocarcinoma or adenosquamous cancer, managed with a potentially curative resection (i.e., removal of all gross tumor). Patients with invasive adenocarcinoma that also contains a component of intraductal papillary mucinous neoplasm (IPMN) are eligible. * Interval between definitive tumor-related surgery and registration between 21-70 days. * Patients will be staged according to the 6th edition AJCC staging system with pathologic stage T1-3, N0-1, M-0 being eligible. * Post resection serum CA19-9 ≤ 180 units/mL within 21 days of registration on study. * Preexisting neuropathy \< grade 1 (per CTCAE). * ECOG performance status 0 or 1. * Age ≥ 18 * Not pregnant and not nursing. Women of child bearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 7 days prior to beginning of treatment. Post-menopausal women (surgical menopause of lack of menses \>12 months) do not need to have a pregnancy test, please document status. * Women of childbearing potential and sexually active males must use an effective contraception method during treatment and for three months after completing treatment. * Required Initial Laboratory Values: * Neutrophils ≥ 1,500/mm3 * Platelet count ≥ 100,000/mm3 * Creatinine ≤ 1.5 mg/dL -or- creatinine clearance ≥ 60 mL/min * Total bilirubin ≤ 1.5 x ULN * AST (SGOT) & ALT (SGPT) ≤ 2.5 x ULN * Alkaline phosphatases \< 2.5x ULN * Abdominal CT scan with contrast and chest CT/x-ray (CT of chest preferred) within 6 weeks of registration on study. Patients can have PET/MRI of the chest/abdomen instead.
Exclusion criteria
* Patients with serious medical risk factors involving any of the major organ systems such that the investigator considers it unsafe for the patient to receive FOLFOX-A * Prior hypersensitivity to Oxaliplatin or Abraxane that in the investigators opinion would put the patient at risk if re-exposed * Patients with islet cell (neuroendocrine) tumors, cystadenomas, cystadenocarcinomas, carcinoid tumors, duodenal carcinomas, distal bile duct, and ampullary carcinomas. * Prior systemic chemotherapy for pancreas cancer; note that prior chemotherapy for a different cancer is allowable. Patients must not have received chemotherapy for a year prior to registering on study * No prior invasive malignancy within the prior two years. However, patients with an early stage malignancy that is not expected to require treatment in the next 2 years (such as early stage, resected breast cancer or asymptomatic prostate cancer) are eligible. This must be documented.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Adjuvant FOLFOX-A | Up to 24 weeks | Determination of the feasibility of administration of adjuvant FOLFOX-A in patients who have undergone resection of pancreatic cancer.Successful administration of FOLFOX-A will be defined as the ability to receive ≥8 cycles of FOLFOX-A. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free Survival | Through study completion, an average of 3 years. | To evaluate the disease-free survival for patients with resected pancreatic cancer treated with adjuvant FOLFOX-A. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| FOLFOXA Abraxane: 150mg/m2 IV over 30 minutes, day 1 (administered first) every 14 days.
Oxaliplatin: 85mg/m2, IV over 2 hours, day 1 every 14 days Leucovorin: 400mg/m2, IV over 2 hours, day 1 every 14 days 5-FU infusion:1200mg/m2/day, as a continuous IV infusion over 2 days, day 1 and day 2 (for a total dose of 2400mg/m2 over 46 hours.) | 25 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 1 |
Baseline characteristics
| Characteristic | FOLFOXA |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 9 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants |
| Age, Continuous | 60 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 23 Participants |
| Region of Enrollment United States | 25 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 25 |
| other Total, other adverse events | 25 / 25 |
| serious Total, serious adverse events | 1 / 25 |
Outcome results
Primary
Feasibility of Adjuvant FOLFOX-A
Determination of the feasibility of administration of adjuvant FOLFOX-A in patients who have undergone resection of pancreatic cancer.Successful administration of FOLFOX-A will be defined as the ability to receive ≥8 cycles of FOLFOX-A.
Time frame: Up to 24 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FOLFOXA | Feasibility of Adjuvant FOLFOX-A | 18 Participants |
Secondary
Disease-free Survival
To evaluate the disease-free survival for patients with resected pancreatic cancer treated with adjuvant FOLFOX-A.
Time frame: Through study completion, an average of 3 years.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| FOLFOXA | Disease-free Survival | 6 months after completion of drug | 23 Participants |
| FOLFOXA | Disease-free Survival | 12 months after completion of drug | 15 Participants |
| FOLFOXA | Disease-free Survival | 24 months after completion of drug | 12 Participants |
| FOLFOXA | Disease-free Survival | 36 months after completion of drug | 8 Participants |