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Alkylating agents
FOLFOXIRI + Panitumumab for Colorectal Cancer
Phase 2
Waitlist Available
Led By Howard Hochster, MD
Research Sponsored by Criterium, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 6 months after the study in such a manner that the risk of pregnancy is minimized
Subjects >=18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up patients will be followed until death or 5 years
Awards & highlights
Study Summary
This trial is testing a new cancer treatment for people with RAS WT advanced adenocarcinoma of the colon or rectum who have not had any prior systemic therapy for metastatic disease.
Who is the study for?
Adults with left-sided RAS wild-type advanced colorectal cancer who haven't had systemic therapy for metastatic disease can join. They must have measurable disease, be in good physical condition (ECOG 0-1), and use effective contraception. Exclusions include pregnancy, breastfeeding, certain past cancers or conditions like lung disease, bleeding disorders, severe allergies to monoclonal antibodies, uncontrolled infections or cardiovascular issues.Check my eligibility
What is being tested?
The trial is testing the effectiveness of FOLFOXIRI combined with Panitumumab in treating metastatic colorectal cancer on the left side that hasn't spread elsewhere. It's an open-label phase II study where all participants receive the treatment without being randomly assigned to different groups.See study design
What are the potential side effects?
Possible side effects may include reactions related to Panitumumab such as skin problems and infusion reactions; Oxaliplatin could cause nerve damage leading to numbness or tingling sensations. There might also be general chemotherapy-related effects like fatigue, digestive issues and lowered blood cell counts.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am using effective birth control to prevent pregnancy during and up to 6 months after the study.
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I am 18 years old or older.
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My diagnosis is advanced colon or rectal cancer.
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I have not had chemotherapy for cancer that has spread.
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My cancer returned within 6 months after finishing chemotherapy.
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My cancer is RAS wild-type.
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I can carry out all my daily activities without help.
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My kidney function is within the normal range.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ patients will be followed until death or 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~patients will be followed until death or 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Efficacy/objective response rate
Secondary outcome measures
Evaluating for the velocity of tumor response to this regimen
Evaluating overall survival (OS)
Evaluating progression free survival (PFS)
+2 moreSide effects data
From 2016 Phase 4 trial • 128 Patients • NCT0158899068%
Nausea
63%
Neuropathy peripheral
63%
Fatigue
55%
Diarrhoea
40%
Constipation
31%
Abdominal pain
30%
Palmar-plantar erythrodysaesthesia syndrome
28%
Vomiting
25%
Neutropenia
24%
Mucosal inflammation
23%
Epistaxis
22%
Decreased appetite
20%
Paraesthesia
20%
Insomnia
20%
Alopecia
20%
Gastrooesophageal reflux disease
19%
Headache
18%
Hypertension
17%
Stomatitis
17%
Back pain
16%
Urinary tract infection
16%
Rash
16%
Dysgeusia
14%
Upper respiratory tract infection
14%
Pain in extremity
13%
Mouth ulceration
13%
Thrombocytopenia
13%
Arthralgia
12%
Anaemia
12%
Dysaesthesia
11%
Weight decreased
11%
Oedema peripheral
11%
Musculoskeletal pain
10%
Dyspnoea
10%
Cough
10%
Abdominal pain upper
10%
Dyspepsia
10%
Pulmonary embolism
10%
Dizziness
9%
Dysphonia
9%
Depression
9%
Pyrexia
8%
Anxiety
8%
Dry skin
8%
Fall
8%
Proteinuria
7%
Lethargy
7%
Abdominal distension
7%
Rectal haemorrhage
7%
Toothache
7%
Neck pain
6%
Dehydration
6%
Oropharyngeal pain
6%
Rhinorrhoea
6%
Non-cardiac chest pain
5%
Intestinal obstruction
5%
Hypoalbuminaemia
5%
Nail disorder
5%
Hypotension
5%
Haemorrhoids
5%
Oral candidiasis
5%
Oral herpes
5%
Hypokalaemia
5%
Muscle spasms
5%
Sepsis
2%
Gastroenteritis
2%
Bronchitis
2%
Lower respiratory tract infection
2%
Pneumonia
2%
Small intestinal obstruction
2%
Anal abscess
2%
Flank pain
2%
Renal failure acute
2%
Confusional state
2%
Febrile neutropenia
2%
Angina pectoris
2%
Enterovesical fistula
1%
Intestinal perforation
1%
Gastrointestinal perforation
1%
Infective exacerbation of chronic obstructive airways disease
1%
Inguinal hernia
1%
Colitis
1%
Colonic obstruction
1%
Muscle abscess
1%
Infected dermal cyst
1%
Clostridium difficile colitis
1%
Ileus
1%
Anal fissure
1%
Gastroenteritis viral
1%
Lobar pneumonia
1%
Pharyngitis
1%
Pneumonia streptococcal
1%
Large intestine perforation
1%
Melaena
1%
Neutropenic colitis
1%
Cholecystitis acute
1%
Urosepsis
1%
Wound infection
1%
Infusion related reaction
1%
Procedural site reaction
1%
Cerebrovascular accident
1%
Hemiparesis
1%
Syncope
1%
Rectal perforation
1%
Catheter site pain
1%
Extravasation
1%
Abscess limb
1%
Radius fracture
1%
Hypomagnesaemia
1%
Hypophagia
1%
Haematuria
1%
Hydronephrosis
1%
Urinary incontinence
1%
Pleural effusion
1%
Pleuritic pain
1%
Musculoskeletal chest pain
1%
Procedural pain
1%
Laceration
1%
Gastrointestinal haemorrhage
1%
Large intestinal obstruction
1%
Transient ischaemic attack
1%
Acute psychosis
1%
Pneumonia aspiration
1%
Jugular vein thrombosis
1%
Orthostatic hypotension
1%
Thrombophlebitis superficial
1%
Device related infection
1%
Ear infection
1%
Enterocolitis infectious
1%
Eyelid infection
1%
Gangrene
1%
Pilonidal cyst
1%
Gastritis
1%
Visual impairment
1%
Dysphagia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bevacizumab: Phase A and Phase B
Trial Design
1Treatment groups
Experimental Treatment
Group I: ActiveExperimental Treatment1 Intervention
This is an open label study single arm
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Panitumumab
FDA approved
Find a Location
Who is running the clinical trial?
Criterium, Inc.Lead Sponsor
16 Previous Clinical Trials
747 Total Patients Enrolled
AmgenIndustry Sponsor
1,370 Previous Clinical Trials
1,377,661 Total Patients Enrolled
Howard Hochster, MDPrincipal InvestigatorLead Site PI
2 Previous Clinical Trials
74 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My blood clotting tests are normal and I've been on a stable dose of blood thinners for at least two weeks.I have only had skin cancer, cervical pre-cancer, or any cancer that hasn't come back in 3 years.My brain-related condition is under control with treatment.I haven't had major surgery or significant injury in the last 28 days and don't expect to need major surgery during the study, except for colorectal cancer surgery or a central line for chemo.I had a transplant and am on drugs to suppress my immune system.I haven't had serious heart problems in the last 6 months.I have a lung condition like pneumonitis or pulmonary fibrosis.I am using effective birth control to prevent pregnancy during and up to 6 months after the study.I agree to use effective birth control during and up to 6 months after the study.I am not pregnant or breastfeeding.I am not pregnant or have a negative pregnancy test before starting the study drug.I am not taking sorivudine, brivudine, or similar antiviral drugs.I have a known DPD deficiency.I have had a severe allergic reaction to monoclonal antibodies.I am 18 years old or older.My diagnosis is advanced colon or rectal cancer.I have not had chemotherapy for cancer that has spread.I finished my chemotherapy for early-stage cancer more than 6 months ago.My cancer returned within 6 months after finishing chemotherapy.My cancer is RAS wild-type.I can carry out all my daily activities without help.I have fully recovered from all my past surgeries.My kidney function is within the normal range.I do not have any ongoing or untreated infections.I have severe wounds or broken bones that are not healing.You have a known allergy to the study drugs or any substances produced when the drugs are broken down in the body.I do not have severe nerve damage, except for possible loss of reflexes.
Research Study Groups:
This trial has the following groups:- Group 1: Active
Awards:
This trial has 3 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
In what medical scenarios is this medication typically prescribed?
"Colorectal carcinoma, ovarian cancer, and sarcoma are all malignancies that can be targeted with this therapeutic intervention."
Answered by AI
To what extent does this treatment pose a risk for patients?
"Given the fact that this treatment is part of a Phase 2 trial, with pre-existing data only supporting safety and not efficacy, our team at Power assigned it an overall score of 2."
Answered by AI
Can you cite any other research that has focused on this treatment?
"Currently, there are 579 ongoing studies into this treatment and 172 of them have reached Phase 3. Many clinical trials for the therapy are based in Guangzhou, Guangdong; however, an incredible 22852 medical centres across the world offer these tests."
Answered by AI
How many individuals are participating in the current experiment?
"The medical trial requires 35 eligible individuals to partake in the study. Potential participants can find a location near them with sites such as Yale Cancer Center located in New Haven, Connecticut and University of Iowa Hospitals & Clinics situated within Iowa City, Iowa."
Answered by AI
Is this research endeavor recruiting participants at present?
"Affirmative, the information on clinicaltrials.gov shows that this research initiative is actively enrolling participants. The project was launched in December 2nd 2019 and its most recent update was posted on December 2nd 2022. 35 volunteers are necessary to be recruited from 8 different medical centres."
Answered by AI
Are there numerous sites across North America administering this clinical trial?
"Currently, 8 clinical trial sites are enrolling patients. These centres can be found in New Haven, Iowa City, Westwood and other nearby locations; thus it is beneficial to choose a local clinic to reduce the amount of travel necessary should you decide to partake."
Answered by AI
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