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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
Must not have
Major surgical procedure, open biopsy, nor significant traumatic injury within 28 days prior to study treatment start, or anticipation of the need for major surgical procedure during the course of the study except for surgery for colorectal cancer with curative intent and central venous line placement for chemotherapy administration
History or evidence upon physical examination of CNS disease unless adequately treated (e.g. primary brain tumor, seizure not controlled with standard medical therapy, brain metastases or history of stroke)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up patients will be followed until death or 5 years
Awards & highlights
Approved for 5 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group

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.
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.
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 below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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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.
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My brain-related condition is under control with treatment.
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I had a transplant and am on drugs to suppress my immune system.
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I have a lung condition like pneumonitis or pulmonary fibrosis.
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I am not pregnant or breastfeeding.
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I am not pregnant or have a negative pregnancy test before starting the study drug.
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I am not taking sorivudine, brivudine, or similar antiviral drugs.
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I have a known DPD deficiency.
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I have had a severe allergic reaction to monoclonal antibodies.
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I do not have any ongoing or untreated infections.
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I have severe wounds or broken bones that are not healing.
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I do not have severe nerve damage, except for possible loss of reflexes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~patients will be followed until death or 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and patients will be followed until death or 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Efficacy/objective response rate
Secondary study objectives
Evaluating for the velocity of tumor response to this regimen
Evaluating overall survival (OS)
Evaluating progression free survival (PFS)
+2 more

Side effects data

From 2016 Phase 4 trial • 128 Patients • NCT01588990
68%
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%
Alopecia
20%
Paraesthesia
20%
Insomnia
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%
Cough
10%
Dyspnoea
10%
Abdominal pain upper
10%
Dyspepsia
10%
Pulmonary embolism
10%
Dizziness
9%
Depression
9%
Dysphonia
9%
Pyrexia
8%
Anxiety
8%
Fall
8%
Proteinuria
8%
Dry skin
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%
Hypoalbuminaemia
5%
Nail disorder
5%
Intestinal obstruction
5%
Hypotension
5%
Haemorrhoids
5%
Oral candidiasis
5%
Oral herpes
5%
Hypokalaemia
5%
Muscle spasms
5%
Sepsis
2%
Bronchitis
2%
Gastroenteritis
2%
Pneumonia
2%
Lower respiratory tract infection
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%
Procedural site reaction
1%
Gastrointestinal perforation
1%
Wound infection
1%
Gastroenteritis viral
1%
Infected dermal cyst
1%
Pneumonia streptococcal
1%
Lobar pneumonia
1%
Inguinal hernia
1%
Muscle abscess
1%
Clostridium difficile colitis
1%
Intestinal perforation
1%
Infusion related reaction
1%
Pharyngitis
1%
Infective exacerbation of chronic obstructive airways disease
1%
Anal fissure
1%
Colitis
1%
Ileus
1%
Colonic obstruction
1%
Large intestine perforation
1%
Melaena
1%
Neutropenic colitis
1%
Cholecystitis acute
1%
Urosepsis
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

Awards & Highlights

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.

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
1,433 Previous Clinical Trials
1,395,134 Total Patients Enrolled
Howard Hochster, MDPrincipal InvestigatorLead Site PI
2 Previous Clinical Trials
74 Total Patients Enrolled

Media Library

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Colorectal Cancer Research Study Groups: Active
Colorectal Cancer Clinical Trial 2023: Oxaliplatin Highlights & Side Effects. Trial Name: NCT04169347 — Phase 2
Oxaliplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04169347 — Phase 2
~0 spots leftby Dec 2024
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