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Chemotherapy

FOLFOXA for Pancreatic Cancer

Q: What conditions is FOLFOXA typically employed to combat?

<p>FOLFOXA is primarily used to treat locally advanced non-<a href="https://www.withpower.com/clinical-trials/small-cell-lung-cancer">small cell lung cancer</a>, but its administration can also be beneficial for metastatic <a href="https://www.withpower.com/clinical-trials/bladder-cancer">bladder cancer</a>, acquired immunodeficiency syndrome and advanced thymoma.</p>

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 from date of start of treatment, until the date of first documented progression, whichever came first, assessed up to 3 years

Awards & highlights

Study Summary

This trial will compare two different chemotherapy combinations to see which is more effective in treating locally advanced pancreatic cancer.

Eligible Conditions

Locally Advanced Pancreatic Cancer
Pancreatic Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of start of treatment, until the date of first documented progression, whichever came first, assessed up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of start of treatment, until the date of first documented progression, whichever came first, assessed up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of start of treatment, until the date of first documented progression, whichever came first, assessed up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Response Rate of FOLFOX-A for Patients With Locally Advanced Pancreatic Cancer.

Secondary outcome measures

Overall Survival for Patients With Locally Advanced Pancreatic Cancer Treated With FOLFOX-A

Side effects data

From 2022 Phase 2 trial • 25 Patients • NCT02022033

84%

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

Generalized muscle weakness

Anxiety

Hiccups

Fall

Bloating

Bone pain

Hoarseness

Sore throat

Urinary urgency

Nail Loss

Urticaria

Hypotension

Amnesia

Conjunctivitis

Wound complication

Creatinine increased

Congestion

Depression

Musculoskeletal and Connective tissue disorder

Presyncope

Rash maculo-papular

Dyspnea

Atelectasis

Tinnitus

Flu like symptoms

Dry skin

Allergic rhinitis

Gait disturbance

Gastritis

Hypocalcemia

Sinus disorder

Skin and subcutaneous tissue disorders

Telangiectasia

Blurred vision

Dyspepsia

100%

80%

60%

40%

20%

Study treatment Arm

FOLFOXA

Trial Design

1Treatment groups

Experimental Treatment

Group I: FOLFOXAExperimental Treatment1 Intervention

Schema: 1 cycle = 14 days **It will not be considered a deviation if a cycle or pre-cycle assessment must be adjusted to accommodate scheduling or holidays. Adjustment must be documented with reason to BrUOG** 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.) It is at the discretion of the treating physician to give Neulasta, 6 mg sq x 1 post treatment Antiemetics will be administered as per standard institutional policy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

FOLFOXA

2014

Completed Phase 2

~110

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

howard safranLead Sponsor

8 Previous Clinical Trials

158 Total Patients Enrolled

Brown UniversityLead Sponsor

456 Previous Clinical Trials

558,326 Total Patients Enrolled

Rhode Island HospitalOTHER

260 Previous Clinical Trials

66,979 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent does FOLFOXA pose risks to individuals?

"Based on our assessment, the safety rating of FOLFOXA is a 2 due to clinical data indicating its security but lack of evidence supporting its effectiveness."

Answered by AI

Are there still available slots for individuals to participate in this trial?

"At this time, this medical trial is not accepting patients. It was first posted on July 12th 2016 and last updated February 23rd 2022. Alternately, there are 698 studies that engage participants with pancreatic cancer as well as 1,217 trials involved in FOLFOXA actively recruiting individuals."

Answered by AI

How many participants are enrolled in this experiment?

"At the present moment, this trial is not open for enrollment. It was first posted on July 12th 2016 and last updated on February 23rd 2022. If you are searching for additional studies, there are currently 698 clinical trials recruiting participants with malignant neoplasms of pancreas and 1,217 FOLFOXA studies actively seeking enrollees."

Answered by AI

What conditions is FOLFOXA typically employed to combat?

"FOLFOXA is primarily used to treat locally advanced non-small cell lung cancer, but its administration can also be beneficial for metastatic bladder cancer, acquired immunodeficiency syndrome and advanced thymoma."

Answered by AI

Have prior analyses explored FOLFOXA's efficacy?

"Presently, there are 1,217 live studies exploring FOLFOXA. Out of these trials, 369 have progressed to Phase 3. Most clinical sites for this research are located in Guangzhou and Guangdong - yet 63223 medical centres worldwide are running tests with FOLFOXA as the treatment option."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

FOLFOX-A For Locally Advanced Pancreatic Cancer: A Phase II Brown University Oncology Research Group Trial

howard safran 2016. "FOLFOX-A For Locally Advanced Pancreatic Cancer: A Phase II Brown University Oncology Research Group Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02578732.