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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.
See summary above
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FOLFOXA | Experimental | 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.) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FOLFOXA | Drug | 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.) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free Survival | To evaluate the disease-free survival for patients with resected pancreatic cancer treated with adjuvant FOLFOX-A. | Through study completion, an average of 3 years. |
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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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Howard Safran, MD | BrUOG | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roxanne Wood | Providence | Rhode Island | 02903 | United States | ||
| The Miriam Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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.) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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.) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | Up to 24 weeks |
|
|
Up to 28 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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.) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | General disorders | CTCAE (4.0) | Non-systematic Assessment | Left Hip |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Howard Safran, MD | Brown University Oncology Research Group | 401-863-3000 | BrUOG@BROWN.EDU |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Nov 21, 2018 | Aug 20, 2020 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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|
| Providence |
| Rhode Island |
| 02903 |
| United States |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | Disease-free Survival | To evaluate the disease-free survival for patients with resected pancreatic cancer treated with adjuvant FOLFOX-A. | Posted | Count of Participants | Participants | Through study completion, an average of 3 years. |
|
|
|
| 0 |
| 25 |
| 1 |
| 25 |
| 25 |
| 25 |
| Alkaline phosphatase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Infusion related reaction | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment | Reaction to Oxaliplatin |
|
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Amnesia | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Neutrophil count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Bloating | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Blurred vision | Eye disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Chills | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Congestion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Conjunctivitis | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Creatinine increased | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Edema | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | CTCAE (4.0) | Non-systematic Assessment |
|
| Fatigue | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Gait disturbance | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hoarseness | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Infections and infestations | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Mucositis | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Musculoskeletal and Connective tissue disorder | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nail discoloration | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Nail Loss | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Pain | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Platelet count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Presyncope | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Rash acneiform | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Sinus disorder | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Telangiectasia | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Urinary urgency | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Vomitting | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| White blood cell decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Weight loss | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Wound complication | Injury, poisoning and procedural complications | CTCAE (4.0) | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Flu like symptoms | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
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| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| Title | Measurements |
|---|---|
|
| 36 months after completion of drug |
|