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| Name | Class |
|---|---|
| Lifespan | OTHER |
| Rhode Island Hospital | OTHER |
| Memorial Hospital of Rhode Island | OTHER |
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The purpose of this study is to test the safety, activity and best doses of FOLFOX-A which consists of the standard chemotherapy drugs fluorouracil, leucovorin, oxaliplatin and abraxane. Each of these drugs are currently used in pancreatic cancer.
The experimental part of the study is combining these drugs together in FOLFOX-A.
More active treatments are desperately needed in pancreatic cancer. The regimen of FOLFIRINOX increases survival as compared to gemcitabine but at a cost of increased toxicity. Irinotecan is responsible for much of the toxicity of FOLFIROX but may not contribute significantly to the regimen's activity. Abraxane is a new agent in pancreatic cancer. This albumin-bound nanoparticle form of paclitaxel increases tumor accumulation of paclitaxel though binding of albumin to SPARC in pancreatic cancer stroma. The investigators therefore propose a pilot study of FOLFOX (fluorouracil, leucovorin and oxaliplatin) combined with abraxane to establish the safety and preliminary activity of FOLFOX-A. Patients with inoperable (metastatic and locally advanced) pancreatic cancer will be eligible since the primary outcome is to establish the safety of FOLFOX-A.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose level 1 | Experimental | Abraxane 125 mg/m2, day 1 Oxaliplatin 85 mg/m2, day 1 leucovorin 400 mg/m2, day 1 5-FU Infusion 1200 mg/m2/ days 2 days IV infusion |
|
| Dose level 2/ MTD | Experimental | Abraxane 150 mg/m2, day 1 Oxaliplatin 85 mg/m2, day 1 leucovorin 400 mg/m2, day 1 5-FU Infusion 1200 mg/m2/ days 2 days IV infusion |
|
| Dose level 3 | Experimental | Abraxane 175 mg/m2, day 1 Oxaliplatin 85 mg/m2, day 1 leucovorin 400 mg/m2, day 1 5-FU Infusion 1200 mg/m2/ days 2 days IV infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dose level 1 | Drug | Abraxane 125 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Toxicities to Define MTD of FOLFOX-Abraxane (A) for Newly Diagnosed, Advanced Pancreatic Cancer. | MTD (Abraxane 150 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion) was defined by protocol documented and predefined DLT's in 3 dose levels. | For up to 30 days post completing drug, an expected average of 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate (if Patient's Tumor(s)Are Progressing or Being Controlled) Following Treatment With FOLFOX-A for Patients With Newly Diagnosed, Advanced Pancreatic Cancer. | Data below summarizes number of patients who experienced partial response. Partial response evaluated in this study using the international criteria proposed in the Revised Response Evaluation Criteria in Solid Tumors (RECIST) Guideline version 1.1 Response Criteria Partial Response (PR) At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters |
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Inclusion Criteria:
Pathologically confirmed pancreatic ductal adenocarcinoma.
Metastatic or locally advanced disease.
No prior treatment for pancreatic cancer
Radiographically measurable disease.
No major surgery within 4 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. Laparoscopy and central venous catheter placement are not considered major surgery.
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
Preexisting neuropathy > grade 1.
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 years of age.
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.
Required Initial Laboratory Values:
Exclusion Criteria:
-Patients with known brain metastases
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| Name | Affiliation | Role |
|---|---|---|
| Howard Safran, MD | Brown University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Hospital | Pawtucket | Rhode Island | 02860 | United States | ||
| Rhode Island Hospital (including Newport and East Greenwich locations) |
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental: Dose Level 1 | Abraxane 125 mg/m2, day 1 Oxaliplatin 85 mg/m2, day 1 leucovorin 400 mg/m2, day 1 5-FU Infusion 1200 mg/m2/ days 2 days IV infusion |
| FG001 | Experimental: Dose Level 2/ MTD | Abraxane 150 mg/m2, day 1 Oxaliplatin 85 mg/m2, day 1 leucovorin 400 mg/m2, day 1 5-FU Infusion 1200 mg/m2/ days 2 days IV infusion |
| FG002 | Experimental: Dose Level 3 | Abraxane 175 mg/m2, day 1 Oxaliplatin 85 mg/m2, day 1 leucovorin 400 mg/m2, day 1 5-FU Infusion 1200 mg/m2/ days 2 days IV infusion |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental: Dose Level 1 | Drug: Dose level 1 Abraxane 125 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion Other Names: 5-FU infusion, leuocovorin, oxaliplatin, Abraxane |
| BG001 | Experimental: Dose Level 2/ MTD |
| 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 | Assessment of Toxicities to Define MTD of FOLFOX-Abraxane (A) for Newly Diagnosed, Advanced Pancreatic Cancer. | MTD (Abraxane 150 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion) was defined by protocol documented and predefined DLT's in 3 dose levels. | Posted | Number | participants | For up to 30 days post completing drug, an expected average of 6 months |
|
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Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
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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 | FOLFOX- A | FOLFOX-A Dose levels -1, 1, 2, 3: Three patients will be accrued to level 1. If no dose limiting toxicities (defined in section 5.2) are observed after two cycles of treatment, then accrual to level 2 will proceed. This procedure will continue until level 3 provided that the MTD has not been reached. If a DLT is observed in one of the first 3 patients in a dose level, then accrual for that level will be expanded to 6 patients. Two or more instances of DLT in a cohort of 6 patients will result in the preceding dose level being defined as the MTD. If dose level 1 is not tolerable then dose level -1 will be investigated. Once the MTD is found, the Principal Investigator will determine which dose should be assessed futher and an additional 10 patients will be treated. FOLFOX-A: Three patients will be accrued to level 1. If no dose limiting toxicities (defined in section 5.2) are observed after two cycles of treatment, then accrual to level 2 will proceed. This procedure will continue un |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| AKI | Investigations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| abdominal distention | Investigations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Helena Lau | Brown Oncology Research Group | 4018633000 | helena_lau@brown.edu |
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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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| ID | Term |
|---|---|
| D000077150 | Oxaliplatin |
| D000068196 | Albumin-Bound Paclitaxel |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D017239 | Paclitaxel |
| D043823 | Taxoids |
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|
| Dose level 2/MTD | Drug | Abraxane 150 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion |
|
|
| Dose level 3 | Drug | Abraxane 175 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion |
|
|
| pre-drug until disease progression, whichever comes first, for an expected average of 6 months |
| Providence |
| Rhode Island |
| 02903 |
| United States |
| The Miriam Hospital | Providence | Rhode Island | 02906 | United States |
Drug: Dose level 2/MTD Abraxane 150 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion Other Names: 5-FU infusion, leuocovorin, oxaliplatin, Abraxane |
| BG002 | Experimental: Dose Level 3 | Drug: Dose level 3 Abraxane 175 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion Other Names: 5-FU infusion, leuocovorin, oxaliplatin, Abraxane |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Drug: Dose level 2/MTD Abraxane 150 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion
Other Names:
5-FU infusion, leuocovorin, oxaliplatin, Abraxane
| OG002 | Experimental: Dose Level 3 | Drug: Dose level 3 Abraxane 175 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion Other Names: 5-FU infusion, leuocovorin, oxaliplatin, Abraxan |
|
|
| Secondary | Response Rate (if Patient's Tumor(s)Are Progressing or Being Controlled) Following Treatment With FOLFOX-A for Patients With Newly Diagnosed, Advanced Pancreatic Cancer. | Data below summarizes number of patients who experienced partial response. Partial response evaluated in this study using the international criteria proposed in the Revised Response Evaluation Criteria in Solid Tumors (RECIST) Guideline version 1.1 Response Criteria Partial Response (PR) At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters | Posted | Number | participants | pre-drug until disease progression, whichever comes first, for an expected average of 6 months |
|
|
|
| 19 |
| 35 |
| 35 |
| 35 |
| anemia/HGB | Investigations | Systematic Assessment |
|
| Bili | Investigations | Systematic Assessment |
|
| confusion | Investigations | Systematic Assessment |
|
| constipation | Investigations | Systematic Assessment |
|
| Creatinine | Investigations | Systematic Assessment |
|
| diarrhea | Investigations | Systematic Assessment |
|
| Dizziness | Investigations | Systematic Assessment |
|
| dyspnea | Investigations | Systematic Assessment |
|
| fatigue | Investigations | Systematic Assessment |
|
| fever | Investigations | Systematic Assessment |
|
| Gout/pseuso-gout | Investigations | Systematic Assessment |
|
| hypokalemia | Investigations | Systematic Assessment |
|
| Hypotension | Investigations | Systematic Assessment |
|
| hypoxia | Investigations | Systematic Assessment |
|
| Infection | Investigations | Systematic Assessment |
|
| mucositits | Investigations | Systematic Assessment |
|
| muscle weakness general/M&A/malaise/generalized body aches | Investigations | Systematic Assessment |
|
| Nausea | Investigations | Systematic Assessment |
|
| Pain abdomen | Investigations | Systematic Assessment |
|
| pain extremity (knee,hip,leg,pelvis,arm,neck,shoulder,wrist,rib,elbow, back, toe) | Investigations | Systematic Assessment |
|
| Pleural effusion | Investigations | Systematic Assessment |
|
| pre-syncope | Investigations | Systematic Assessment |
|
| rotator cuff tear | Investigations | Systematic Assessment |
|
| TIA | Investigations | Systematic Assessment |
|
| Thromboemblic event (pulm embol)/DVT | Investigations | Systematic Assessment |
|
| vasovagal | Investigations | Systematic Assessment |
|
| vomiting | Investigations | Systematic Assessment |
|
| wbc | Investigations | Systematic Assessment |
|
| Colonic Obstruction | Investigations | Systematic Assessment |
|
| Allergic reaction to Oxali and overall allergic reaction | Investigations | Systematic Assessment |
|
| alk phos | Investigations | Systematic Assessment |
|
| alopecia | Investigations | Systematic Assessment |
|
| ALT | Investigations | Systematic Assessment |
|
| ANC | Investigations | Systematic Assessment |
|
| anemia/HGB | Investigations | Systematic Assessment |
|
| anorexia | Investigations | Systematic Assessment |
|
| anxiety | Investigations | Systematic Assessment |
|
| AST | Investigations | Systematic Assessment |
|
| blurry vision | Investigations | Systematic Assessment |
|
| BUN | Investigations | Systematic Assessment |
|
| Calcium/CA | Investigations | Systematic Assessment |
|
| Chills/rigors | Investigations | Systematic Assessment |
|
| confusion | Investigations | Systematic Assessment |
|
| constipation | Investigations | Systematic Assessment |
|
| Cough | Investigations | Systematic Assessment |
|
| Creatinine | Investigations | Systematic Assessment |
|
| dehydration | Investigations | Systematic Assessment |
|
| Depression | Investigations | Systematic Assessment |
|
| diarrhea | Investigations | Systematic Assessment |
|
| Dizziness | Investigations | Systematic Assessment |
|
| dysgeusia (taste) | Investigations | Systematic Assessment |
|
| dysuria | Investigations | Systematic Assessment |
|
| dyspnea | Investigations | Systematic Assessment |
|
| edema | Investigations | Systematic Assessment |
|
| eye disorder- other | Investigations | Systematic Assessment |
|
| fatigue | Investigations | Systematic Assessment |
|
| fever | Investigations | Systematic Assessment |
|
| cramping extermeties | Investigations | Systematic Assessment |
|
| flatulanence | Investigations | Systematic Assessment |
|
| Flushing | Investigations | Systematic Assessment |
|
| Folliculitis- scalp | Investigations | Systematic Assessment |
|
| GERD | Investigations | Systematic Assessment |
|
| Gout/pseuso-gout | Investigations | Systematic Assessment |
|
| Headache | Investigations | Systematic Assessment |
|
| hearing impairment | Investigations | Systematic Assessment |
|
| heartburn | Investigations | Systematic Assessment |
|
| hemorrhoids | Investigations | Systematic Assessment |
|
| Hiccups | Investigations | Systematic Assessment |
|
| hypoalbum | Investigations | Systematic Assessment |
|
| hypokalemia | Investigations | Systematic Assessment |
|
| Hypotension | Investigations | Systematic Assessment |
|
| Infection | Investigations | Systematic Assessment |
|
| insomnia | Investigations | Systematic Assessment |
|
| itchiness (head/neck) | Investigations | Systematic Assessment |
|
| LDH | Investigations | Systematic Assessment |
|
| Lymph | Investigations | Systematic Assessment |
|
| mg | Investigations | Systematic Assessment |
|
| memory impairment | Investigations | Systematic Assessment |
|
| mucositits | Investigations | Systematic Assessment |
|
| muscle weakness general/M&A/malaise/generalized body aches | Investigations | Systematic Assessment |
|
| myositis | Investigations | Systematic Assessment |
|
| Nausea | Investigations | Systematic Assessment |
|
| neuropathy | Investigations | Systematic Assessment |
|
| Phos | Investigations | Systematic Assessment |
|
| arthritis | Investigations | Systematic Assessment |
|
| Pain abdomen | Investigations | Systematic Assessment |
|
| Pain bone | Investigations | Systematic Assessment |
|
| Pain chest | Investigations | Systematic Assessment |
|
| pain epigastric | Investigations | Systematic Assessment |
|
| pain extremity (knee,hip,leg,pelvis,arm,neck,shoulder,wrist,rib,elbow, back, toe) | Investigations | Systematic Assessment |
|
| post nasal drip/nasal congestion | Investigations | Systematic Assessment |
|
| Renal Calculi(kidney stones) | Investigations | Systematic Assessment |
|
| skin laceration (L finger) | Investigations | Systematic Assessment |
|
| Skin- dry | Investigations | Systematic Assessment |
|
| sodium/NA | Investigations | Systematic Assessment |
|
| spasticity throat | Investigations | Systematic Assessment |
|
| thrombocytopenia | Investigations | Systematic Assessment |
|
| Thromboemblic event (pulm embol)/DVT | Investigations | Systematic Assessment |
|
| voice alteration(hoarsness) | Investigations | Systematic Assessment |
|
| vomiting | Investigations | Systematic Assessment |
|
| wbc | Investigations | Systematic Assessment |
|
| weight loss | Investigations | Systematic Assessment |
|
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| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D043822 |
| Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |