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| Name | Class |
|---|---|
| Lifespan | OTHER |
| SouthCoast Medical Group | OTHER |
| Memorial hospital | UNKNOWN |
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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.
See summary above
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FOLFOXA | Experimental | 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.) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FOLFOXA | Drug |
|
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Response of Patients With Metastatic Pancreatic Cancer Who Receive the FOLFOX-A Regimen | Every 3 months for up to 5 years. |
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Inclusion Criteria:
Pathologically or cytological confirmed pancreatic ductal adenocarcinoma. Patients with pathology or cytology showing carcinoma of pancreas or adenosquamous of the pancreas are also eligible.
Metastatic advanced disease.
No prior chemotherapy for pancreatic cancer
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.
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.
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 or 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. Documentation of this being discussed required.
Required Initial Laboratory Values:
Exclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Howard Safran, MD | BrUOG | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southcoast centers for cancer care | Fairhaven | Massachusetts | 02179 | United States | ||
| Lifespan Hospitals (The Miriam and RI Hospital, East Greenwich, Newport) |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| 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 | Survival for Patients With Metastatic Pancreatic Cancer With First-line Treatment With FOLFOX-A as Compared to Historical Controls of Gemcitabine Alone. | Posted | Median | 95% Confidence Interval | months | Every 3 months for up to 5 years |
|
|
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 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Investigations | CTCAE (4.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Howard Safran, MD | Brown University Oncology Research Group | 4018633000 | 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 | Dec 26, 2018 | Feb 4, 2021 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D000068196 | Albumin-Bound Paclitaxel |
| D000077150 | Oxaliplatin |
| D002955 | Leucovorin |
| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 |
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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 |
|
|
|
| Secondary | Response of Patients With Metastatic Pancreatic Cancer Who Receive the FOLFOX-A Regimen | Posted | Count of Participants | Participants | Every 3 months for up to 5 years. |
|
|
|
| 2 |
| 48 |
| 10 |
| 48 |
| 48 |
| 48 |
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Enterocolitis | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hemoptysis | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Acidosis | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Acute kidney injury | Injury, poisoning and procedural complications | CTCAE (4.0) | Non-systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Lethargy | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Multi organ failure | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Duodenal perforation | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Duodenal hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Edema limbs | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Fatigue | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Neoplasms benign, malignant, and unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Non-systematic Assessment |
|
| Pain | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Peritonitis | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
|
| Thrombocytopenia | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Small bowel obstruction | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Stroke | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Thromboembolic event | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Blood bilirubin elevated | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
|
| Thrombocytopenia | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Fatigue | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Mucositis oral | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Arthralgia | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Weight loss | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Elevated AST/ALT | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Elevated alkaline phosphatase | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
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| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D056831 | Coordination Complexes |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| Progressive disease |
|