BrUOG 295: Adjuvant FOLFOX-A For Resected Pancreatic Cancer: A Phase II Brown University Oncology Research Group Trial
Primary Purpose
Pancreatic Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
FOLFOXA
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring Pancreatic Cancer, Adjuvant, Pancreas, Resected, Invasive adenocarcinoma, adenosquamous cancer, Intraductal papillary mucinous neoplasm
Eligibility Criteria
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.
Sites / Locations
- Roxanne Wood
- The Miriam Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
FOLFOXA
Arm Description
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.)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Disease-free Survival
To evaluate the disease-free survival for patients with resected pancreatic cancer treated with adjuvant FOLFOX-A.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02022033
Brief Title
BrUOG 295: Adjuvant FOLFOX-A For Resected Pancreatic Cancer: A Phase II Brown University Oncology Research Group Trial
Official Title
BrUOG 295:Adjuvant FOLFOX-A For Resected Pancreatic Cancer: A Phase II Brown University Oncology Research Group Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2014 (Actual)
Primary Completion Date
July 23, 2019 (Actual)
Study Completion Date
March 17, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Brown University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
Pancreatic Cancer, Adjuvant, Pancreas, Resected, Invasive adenocarcinoma, adenosquamous cancer, Intraductal papillary mucinous neoplasm
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FOLFOXA
Arm Type
Experimental
Arm Description
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.)
Intervention Type
Drug
Intervention Name(s)
FOLFOXA
Intervention Description
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.)
Primary Outcome Measure Information:
Title
Feasibility of Adjuvant FOLFOX-A
Description
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
Secondary Outcome Measure Information:
Title
Disease-free Survival
Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Howard Safran, MD
Organizational Affiliation
BrUOG
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roxanne Wood
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
The Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
BrUOG 295: Adjuvant FOLFOX-A For Resected Pancreatic Cancer: A Phase II Brown University Oncology Research Group Trial
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