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Chemotherapy
mFOLFIRINOX + Ramucirumab for Pancreatic Cancer
Phase 2
Waitlist Available
Research Sponsored by Walid Shaib, MD
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 time of registration to the time of documented progression or subject death, assessed up to 33 months
Awards & highlights
Study Summary
This trial is testing a new cancer treatment combination to see if it is more effective and has fewer side effects than the current standard treatment.
Eligible Conditions
- Pancreatic Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from time of registration to the time of documented progression or subject death, assessed up to 33 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from time of registration to the time of documented progression or subject death, assessed up to 33 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression Free Survival (PFS)
Secondary outcome measures
Characterize Adverse Events (AE)
Median Overall Survival (mOS)
Response Rate (RR)
Side effects data
From 2016 Phase 3 trial • 1253 Patients • NCT0116897346%
Fatigue
36%
Neutropenia
32%
Diarrhoea
30%
Decreased appetite
27%
Nausea
26%
Alopecia
24%
Dyspnoea
23%
Stomatitis
22%
Cough
22%
Anaemia
19%
Epistaxis
18%
Neutrophil count decreased
17%
Oedema peripheral
17%
Constipation
16%
Mucosal inflammation
16%
Pyrexia
14%
Lacrimation increased
14%
Vomiting
14%
Febrile neutropenia
13%
Myalgia
13%
Leukopenia
12%
Peripheral sensory neuropathy
12%
Back pain
11%
Dysgeusia
11%
Hypertension
11%
Insomnia
11%
Headache
11%
Arthralgia
11%
Asthenia
11%
Weight decreased
9%
Abdominal pain
9%
White blood cell count decreased
8%
Oropharyngeal pain
8%
Pain in extremity
8%
Thrombocytopenia
7%
Rash
7%
Dizziness
7%
Nail discolouration
6%
Dehydration
6%
Pain
6%
Dyspepsia
6%
Haemoptysis
6%
Paraesthesia
6%
Dysphonia
6%
Productive cough
6%
Hyperglycaemia
6%
Pneumonia
6%
Platelet count decreased
5%
Bone pain
1%
Chronic obstructive pulmonary disease
1%
Hyponatraemia
1%
Metastatic pain
1%
Lobar pneumonia
1%
Pleural effusion
1%
Pneumothorax
1%
Pulmonary embolism
1%
Pulmonary haemorrhage
1%
Syncope
1%
Confusional state
1%
Death
1%
Atrial fibrillation
1%
General physical health deterioration
1%
Renal failure acute
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ramucirumab and Docetaxel
Placebo and Docetaxel
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm A: Experimental ArmExperimental Treatment2 Interventions
mFOLFIRINOX will be administered every 2 weeks, and consist of:
Oxaliplatin 85 mg/m2 over 2-4 hours
Irinotecan 165 mg/m2 over 90 minutes
5-FU 2,400 mg/m2 as a 46-hour continuous infusion without the 5-FU bolus to decrease the risk of neutropenia.
Arm A will receive ramucirumab administered as an intravenous infusion over 60 minutes (infusion rate should not exceed 25 mg/min), at a fixed dose of 8 mg/kg every 2 weeks.
Group II: Arm B: Placebo ArmPlacebo Group2 Interventions
mFOLFIRINOX will be administered every 2 weeks, and consist of:
Oxaliplatin 85 mg/m2 over 2-4 hours
Irinotecan 165 mg/m2 over 90 minutes
5-FU 2,400 mg/m2 as a 46-hour continuous infusion without the 5-FU bolus to decrease the risk of neutropenia.
Arm B will receive a placebo infusion every 2 weeks. Due to the double-blinded nature of this study, the volume of placebo will be calculated as if it were ramucirumab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
mFOLFIRINOX
2013
Completed Phase 2
~40
Ramucirumab
2017
Completed Phase 3
~5050
Find a Location
Who is running the clinical trial?
Walid Shaib, MDLead Sponsor
1 Previous Clinical Trials
Hoosier Cancer Research NetworkOTHER
68 Previous Clinical Trials
3,671 Total Patients Enrolled
Eli Lilly and CompanyIndustry Sponsor
2,618 Previous Clinical Trials
3,201,476 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You currently have an infection that is not getting better.You have had a previous organ or tissue transplant.You have a hole or abnormal passage in your digestive system.You have a type of cancer in the pancreas that is not adenocarcinoma, such as neuroendocrine tumors, acinar cell cancer, sarcoma, or lymphoma.You haven't received certain types of treatment for your disease before, unless it was given before or after surgery. If your disease got worse at least 6 months after your last round of chemotherapy or chemo-radiation, you can still participate.Your disease can be measured using specific guidelines and imaging tests like CT scans or MRI.You are taking certain medications that can affect how your blood clots, such as warfarin, aspirin, or NSAIDs.You have heart problems that cause symptoms like chest pain, irregular heartbeat, or difficulty breathing.Your high blood pressure is not well-controlled even with regular medication.You have a recent or developing blockage in your intestines.You have a lung condition that could make it hard for you to take part in the study, as determined by the doctor at the study site.You have difficulty breathing caused by a buildup of fluid around your lungs or in your abdomen.You have severe liver disease with symptoms like confusion or significant fluid buildup in the abdomen.You had a severe bleeding episode within the last 3 months before the study starts.You have had a heart attack, stroke, or other similar events within the past 6 months.You had a blood clot in a major vein within 3 months before the start of the study.You have been diagnosed with brain or leptomeningeal metastases, or have symptoms related to these conditions.You have a very weak immune system, except if you are taking steroids, or you have HIV.You have another type of cancer that is not skin cancer, but it must have been treated and not come back for at least 3 years.You should be able to perform daily activities without getting tired easily.You have been diagnosed with recurrent or metastatic pancreatic adenocarcinoma and are seeking your first chemotherapy treatment.You must be in good enough health to perform everyday activities without help.You have been diagnosed with recurrent or spreading pancreatic adenocarcinoma and are seeking your first chemotherapy treatment.You have not received certain types of cancer treatment as your first treatment. If your disease got worse after a specific type of treatment, you may still be eligible.Your disease can be measured using specific guidelines for evaluating tumors. You need to have a CT scan or MRI to check the size of your tumor before starting the study.Your urine test shows very low levels of protein, and if it shows higher levels, you will need to do another test to make sure the protein levels are within a certain range.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A: Experimental Arm
- Group 2: Arm B: Placebo Arm
Awards:
This trial has 0 awards, including: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.
What are the primary indications for Ramucirumab?
"Ramucirumab is an effective treatment for patients with non-small cell lung carcinoma, advanced gastric cancer, and colorectal carcinoma."
Answered by AI
Are there any available openings for this clinical trial?
"Unfortunately, this study is not currently enrolling patients according to the latest information on clinicaltrials.gov. This does not mean that there are no other medical studies looking for participants right now-- in fact, there are 776 other active trials."
Answered by AI
When did the FDA last weigh in on Ramucirumab's safety?
"There is some clinical data suggesting that Ramucirumab is safe, but as this is only a Phase 2 trial, there is currently no evidence to support its efficacy. Consequently, it received a score of 2."
Answered by AI
Does this research break new ground in the medical field?
"Currently, 50 ongoing clinical trials exist for Ramucirumab in 869 cities and 34 countries. The first study occurred in 2015, sponsored by Clovis Oncology, Inc. This initial Phase 2 trial included 924 patients and completed drug approval in that same year. Since then, 18340 more studies have been conducted."
Answered by AI
What other scientific research has been conducted using Ramucirumab?
"Ramucirumab was first trialed in 2015 at The Royal Marsden NHS Foundation Trust. To date, there have been a grand total of 18340 similar clinical trials completed with 50 more underway as of now. Many of these studies are being conducted out of the city of Indianapolis, Indiana."
Answered by AI
Who else is applying?
What state do they live in?
Kentucky
Indiana
New York
Other
How old are they?
65+
18 - 65
What site did they apply to?
Indiana University Melvin and Bren Simon Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
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