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Anti-tumor antibiotic
FOLFOXA for Pancreatic Cancer
Phase 2
Waitlist Available
Led By Howard Safran, MD
Research Sponsored by howard safran
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 3 months for up to 5 years
Awards & highlights
Study Summary
This trial is testing a new combination of chemotherapy drugs to see if it is more effective and has fewer side effects than the standard treatment for pancreatic cancer.
Eligible Conditions
- Pancreatic Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every 3 months for up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 3 months for up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Survival for Patients With Metastatic Pancreatic Cancer With First-line Treatment With FOLFOX-A as Compared to Historical Controls of Gemcitabine Alone.
Secondary outcome measures
Response of Patients With Metastatic Pancreatic Cancer Who Receive the FOLFOX-A Regimen
Side effects data
From 2022 Phase 2 trial • 25 Patients • NCT0202203384%
Peripheral sensory neuropathy
72%
Fatigue
64%
Nausea
60%
Alkaline phosphatase increased
56%
Weight loss
56%
Anemia
56%
Hypokalemia
56%
Alopecia
52%
Neutrophil count decreased
48%
Hypertension
40%
Diarrhea
40%
Platelet count decreased
40%
White blood cell decreased
36%
Alanine aminotransferase increased
36%
Pain
36%
Mucositis
36%
Aspartate aminotransferase increased
32%
Infections and infestations
32%
Lymphocyte count decreased
32%
Vomitting
28%
Myalgia
24%
Anorexia
24%
Insomnia
20%
Constipation
20%
Dehydration
20%
Dysgeusia
16%
Arthralgia
16%
Edema
16%
Infusion related reaction
16%
Flatulence
16%
Rash acneiform
16%
Hyponatremia
16%
Dizziness
12%
Cough
12%
Chills
12%
Nail discoloration
12%
Headache
12%
Hypoalbuminemia
8%
Generalized muscle weakness
8%
Anxiety
8%
Hiccups
8%
Fall
8%
Bloating
8%
Bone pain
8%
Hoarseness
8%
Sore throat
8%
Urinary urgency
4%
Nail Loss
4%
Urticaria
4%
Hypotension
4%
Amnesia
4%
Conjunctivitis
4%
Wound complication
4%
Creatinine increased
4%
Congestion
4%
Depression
4%
Musculoskeletal and Connective tissue disorder
4%
Presyncope
4%
Rash maculo-papular
4%
Dyspnea
4%
Atelectasis
4%
Tinnitus
4%
Flu like symptoms
4%
Dry skin
4%
Allergic rhinitis
4%
Gait disturbance
4%
Gastritis
4%
Hypocalcemia
4%
Sinus disorder
4%
Skin and subcutaneous tissue disorders
4%
Telangiectasia
4%
Blurred vision
4%
Dyspepsia
100%
80%
60%
40%
20%
0%
Study treatment Arm
FOLFOXA
Trial Design
1Treatment groups
Experimental Treatment
Group I: FOLFOXAExperimental Treatment1 Intervention
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.)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Menthol
FDA approved
Find a Location
Who is running the clinical trial?
howard safranLead Sponsor
8 Previous Clinical Trials
136 Total Patients Enrolled
LifespanOTHER
40 Previous Clinical Trials
41,038 Total Patients Enrolled
Brown UniversityLead Sponsor
456 Previous Clinical Trials
558,304 Total Patients Enrolled
Frequently Asked Questions
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