Metastatic Pancreatic Cancer
Conditions
Keywords
metastatic pancreatic cancer, pancreatic cancer, metastatic
Brief summary
A standard treatment for your cancer is called FOLFIRINOX (this utilizes the FDA approved chemotherapy drugs fluorouracil, leucovorin, oxaliplatin and irinotecan). In this study you will receive the chemotherapy treatment FOLFOX-A (fluorouracil, oxaliplatin, leucovorin and Abraxane ®) which substitutes irinotecan for the FDA approved chemotherapy drug Abraxane ®. Even though Abraxane is FDA approved for pancreatic cancer, the combination of Abraxane with the other 3 drugs is being investigated. Your doctors are studying the activity and side effects of FOLFOX-A in advanced (metastatic) pancreatic cancer.
Detailed description
See summary above
Interventions
DRUGFOLFOXA
Sponsors
Lifespan
SouthCoast Medical Group
Memorial hospital
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
1. Pathologically or cytological confirmed pancreatic ductal adenocarcinoma. Patients with pathology or cytology showing carcinoma of pancreas or adenosquamous of the pancreas are also eligible. 2. Metastatic advanced disease. 3. No prior chemotherapy for pancreatic cancer 4. No major surgery within 3 weeks of the start of study treatment. Patients must have recovered from the side effects of any major surgery at the start of study treatment. For questions on if a surgery is deemed major, definition by surgeon can be used for clarification. Laparoscopy and central venous catheter placement are not considered major surgery. 5. 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. 6. ECOG performance status 0 or 1. 7. Age ≥ 18 8. 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 or lack of menses \>12 months) do not need to have a pregnancy test, please document status. 9. Women of childbearing potential and sexually active males must use an effective contraception method during treatment and for three months after completing treatment. Documentation of this being discussed required. 10. 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 ≤ 1.25 x ULN * AST (SGOT) & ALT (SGPT) ≤ 2.5 x ULN (for patients with liver metastases, AST&ALT \< 5xULN) * Alkaline phosphatase \< 2.5xULN, unless bone metastasis is present and in the absence of liver metastasis
Exclusion criteria
1. Patients with known brain metastases 2. Prior hypersensitivity to Oxaliplatin or Abraxane ® that in the investigators opinion would put the patient at risk if re-exposed 3. Preexisting neuropathy 4. 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 5. Patients with unstable biliary stents or with plastic stents. Information on type of stent is required at registration. 6\. Patients with active infection or fever (patients on antibiotics for infection or patients getting over a cold or seasonal virus are not excluded), or known historical or active infection with HIV, hepatitis B, or hepatitis C. 7\. Patients with sepsis or pneumonitis. 8. Patients with a history of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies that in the investigator's opinion would put the patient at an increased risk. 10\. Uncontrolled diabetes. If patient has diabetes, confirmation on status (controlled or uncontrolled) required at registration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival for Patients With Metastatic Pancreatic Cancer With First-line Treatment With FOLFOX-A as Compared to Historical Controls of Gemcitabine Alone. | Every 3 months for up to 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Response of Patients With Metastatic Pancreatic Cancer Who Receive the FOLFOX-A Regimen | Every 3 months for up to 5 years. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| FOLFOXA 1 cycle = 14 days 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.)
FOLFOXA | 50 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Clinical Progression of Disease | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | FOLFOXA |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 32 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants |
| Age, Continuous | 66 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 | 2 Participants |
| Race (NIH/OMB) White | 46 Participants |
| Region of Enrollment United States | 50 participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 48 |
| other Total, other adverse events | 48 / 48 |
| serious Total, serious adverse events | 10 / 48 |
Outcome results
Primary
Survival for Patients With Metastatic Pancreatic Cancer With First-line Treatment With FOLFOX-A as Compared to Historical Controls of Gemcitabine Alone.
Time frame: Every 3 months for up to 5 years
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| FOLFOXA | Survival for Patients With Metastatic Pancreatic Cancer With First-line Treatment With FOLFOX-A as Compared to Historical Controls of Gemcitabine Alone. | Progression- free survival | 5 months |
| FOLFOXA | Survival for Patients With Metastatic Pancreatic Cancer With First-line Treatment With FOLFOX-A as Compared to Historical Controls of Gemcitabine Alone. | Overall survival | 11 months |
Secondary
Response of Patients With Metastatic Pancreatic Cancer Who Receive the FOLFOX-A Regimen
Time frame: Every 3 months for up to 5 years.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| FOLFOXA | Response of Patients With Metastatic Pancreatic Cancer Who Receive the FOLFOX-A Regimen | Complete response | 2 Participants |
| FOLFOXA | Response of Patients With Metastatic Pancreatic Cancer Who Receive the FOLFOX-A Regimen | Partial response | 12 Participants |
| FOLFOXA | Response of Patients With Metastatic Pancreatic Cancer Who Receive the FOLFOX-A Regimen | Stable disease | 12 Participants |
| FOLFOXA | Response of Patients With Metastatic Pancreatic Cancer Who Receive the FOLFOX-A Regimen | Progressive disease | 22 Participants |