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Anti-metabolites
Chemotherapy for Pancreatic Cancer
Phase 2
Recruiting
Research Sponsored by Fox Chase Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have bone marrow and organ function within specified ranges.
Age 65 years or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing a new chemotherapy regimen for pancreatic cancer in elderly patients.
Who is the study for?
This trial is for people over 65 with a specific type of untreated pancreatic cancer that has spread. They must have finished any previous radiation at least 2 weeks before and any adjuvant therapy over 6 months prior to consent. Participants need good organ function, understand English, be able to complete assessments, and use effective contraception if applicable.Check my eligibility
What is being tested?
The study tests the effectiveness of alternating FOLFOX and FOLFIRI chemotherapy regimens in older patients with metastatic pancreatic cancer. It aims to evaluate how well they tolerate this treatment combination and what toxic effects may occur.See study design
What are the potential side effects?
Possible side effects include reactions related to chemotherapy such as nausea, vomiting, diarrhea, fatigue, decreased blood cell counts leading to increased infection risk or bleeding problems, nerve damage causing numbness or tingling sensations.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My blood tests show my organs and bone marrow are working well.
Select...
I am 65 years old or older.
Select...
I am able to get out of my bed or chair and move around.
Select...
I have a new, untreated pancreatic cancer that has spread, with measurable tumors.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To assess the toxicity profile of a regimen of alternating FOLFOX and FOLFIRI patients assessed as per NCI's CTCAE v5.0 criteria.
Secondary outcome measures
To assess the Delayed Toxicity Rate
To assess the Objective Response Rate (ORR)
To assess the Overall Survival (OS)
+1 moreSide effects data
From 2017 Phase 2 trial • 32 Patients • NCT0183979982%
fatigue
82%
diarrhea
76%
nausea
59%
vomiting
59%
neutropenia
41%
neuropathy
35%
mucositis
35%
dehydration
35%
Mouth Sores
29%
decreased wbc
29%
fever
29%
gas
29%
abdominal pain
29%
hypokalemia
24%
Fever
24%
constipation
24%
hyperglycemia
18%
Insomnia
18%
decreased plt
18%
decreased neutrophils
18%
Nausea
18%
Vomiting
18%
Diarrhea
18%
rash
18%
anorexia
18%
weight loss
18%
UTI
18%
Decreased Platlets
12%
hypotension
12%
Dizziness
12%
hypoalbuminemia
12%
Decreased Appetite
12%
Abdominal pain
12%
decrease wbc
12%
anemia
12%
dysgeusia
12%
Alopecia
12%
Anxiety
12%
peripheral neuropathy
12%
Depression
6%
ratiation dermatitis
6%
abdominal cramping
6%
Ear Bleed -L-ear
6%
increased Ast
6%
hypersensitivity reaction
6%
Muscle twitching
6%
loose stools/intermittent
6%
decreased appetite
6%
paronychia
6%
elevated ALK Phos
6%
Runny nose
6%
protein malnutrition
6%
Viral Syndrome
6%
GI Bleed
6%
Syncope
6%
hepatic infection (SAE)
6%
Non-neutropenic fever
6%
Dehydration
6%
Thrombocytopenia
6%
increased abd distention
6%
CMV
6%
thrombocytopenia
6%
headache
6%
dry skin
6%
skin infection port
6%
abd/cramping/pain
6%
hiccoughs
6%
gout
6%
Lightheadeness
6%
night sweats
6%
flatulance
6%
Thick feeling tongue
6%
Cold Sensitivity
6%
Nasal Congestion
6%
Tunnel Vision
6%
Chest Pressure/Spasm
6%
Gastric Ulcer
6%
Neutropenia
6%
Urinary Incontinence
6%
hypomagnesium
6%
Myalgia
6%
Dyspepsia
6%
Loose bowel movement
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm 1
Arm 2
Trial Design
1Treatment groups
Experimental Treatment
Group I: Experimental: FOLFIRINOXExperimental Treatment1 Intervention
FOLFIRINOX: Oxaliplatin, Leucovorin and 5-Fluorouracl, Irinotecan,
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
FOLFIRINOX
2013
Completed Phase 3
~790
Find a Location
Who is running the clinical trial?
Fox Chase Cancer CenterLead Sponsor
227 Previous Clinical Trials
37,472 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are not currently receiving or have not previously received any other experimental treatment for advanced pancreatic cancer.My blood tests show my organs and bone marrow are working well.I do not have any severe illnesses that could interfere with the study.I am 65 years old or older.I am able to get out of my bed or chair and move around.My cancer is a type of pancreatic cancer.I have brain metastases, whether treated or not.You have a weakened immune system, HIV, hepatitis B, or untreated or unsuccessfully treated hepatitis C.I haven't had chemotherapy for cancer that has spread or cannot be removed by surgery.I have not had radiation therapy in the last 2 weeks.I have severe nerve damage in my hands or feet.I finished radiation therapy over 2 weeks ago and had my last adjuvant therapy more than 6 months ago.I agree to use effective birth control during the study.I have had chronic diarrhea for more than 2 weeks despite treatment.I am eligible for this study regardless of my gender, race, or sexual orientation.I have had cancer signs within the last 2 years without complete treatment.You have had more than two falls in the past month or your body mass index (BMI) is less than 18.I have a new, untreated pancreatic cancer that has spread, with measurable tumors.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental: FOLFIRINOX
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still opportunities for individuals to join this clinical experiment?
"As of this moment, the study is still enrolling patients into its experiments. According to clinicaltrials.gov, it was initially advertised on April 22nd 2022 and has been modified as recently as September 26th 2022."
Answered by AI
What is the current enrollment capacity for this clinical trial?
"Affirmative. According to information posted on clinicaltrials.gov, this medical trial is actively seeking participants and was initially published on April 22nd 2022. The study has updated its recruitment efforts as recently as September 26th of the same year and needs 37 individuals from a single site to complete it."
Answered by AI
Has the FOLFIRINOX medication been approved by the Food and Drug Administration?
"Due to the Phase 2 nature of this trial, our team has judged that FOLFIRINOX carries a safety rating of 2 since there is some evidence for its safety but not yet any definitive proof of efficacy."
Answered by AI
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