← Back to Search

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 below
Select...
I am using effective birth control to prevent pregnancy during and up to 6 months after the study.
Select...
I am 18 years old or older.
Select...
My diagnosis is advanced colon or rectal cancer.
Select...
I have not had chemotherapy for cancer that has spread.
Select...
I finished my chemotherapy for early-stage cancer more than 6 months ago.
Select...
My cancer returned within 6 months after finishing chemotherapy.
Select...
My cancer is RAS wild-type.
Select...
I can carry out all my daily activities without help.
Select...
I have fully recovered from all my past surgeries.
Select...
My kidney function is within the normal range.

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

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 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%
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%
Cough
10%
Dyspnoea
10%
Abdominal pain upper
10%
Dyspepsia
10%
Pulmonary embolism
10%
Dizziness
9%
Depression
9%
Dysphonia
9%
Pyrexia
8%
Dry skin
8%
Fall
8%
Anxiety
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%
Hypoalbuminaemia
5%
Intestinal obstruction
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%
Infective exacerbation of chronic obstructive airways disease
1%
Anal fissure
1%
Colitis
1%
Colonic obstruction
1%
Inguinal hernia
1%
Muscle abscess
1%
Infected dermal cyst
1%
Gastroenteritis viral
1%
Gastrointestinal perforation
1%
Clostridium difficile colitis
1%
Ileus
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
1,362 Previous Clinical Trials
1,385,239 Total Patients Enrolled
Howard Hochster, MDPrincipal InvestigatorLead Site PI
2 Previous Clinical Trials
74 Total Patients Enrolled

Media Library

Oxaliplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT04169347 — Phase 2
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

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
~3 spots leftby Dec 2024