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Panitumumab for Colorectal Cancer

Phase 2

Waitlist Available

Led By Nancy Kemeny, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Completely resected hepatic metastases without current evidence of other metastatic disease

History of histologically confirmed colorectal adenocarcinoma metastatic to the liver with no clinical or radiographic evidence of extrahepatic disease confirmed at MSKCC

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial is testing if adding Panitumumab to the usual treatments for this cancer will help keep it in remission for longer.

Who is the study for?

This trial is for adults with colorectal cancer that has spread to the liver but was surgically removed, and there's no sign of cancer elsewhere. They must have normal blood counts, kidney and liver function, not be pregnant or breastfeeding, and haven't had certain treatments like HAI FUDR or anti-EGFR therapy if it didn't work before.Check my eligibility

What is being tested?

The study tests whether adding Panitumumab to standard chemotherapy (Irinotecan, 5FU, Leucovorin) after surgery can extend the time patients remain cancer-free. Participants are randomly assigned to receive either this combination or just the chemotherapy without Panitumumab.See study design

What are the potential side effects?

Panitumumab may cause skin reactions, low magnesium levels, allergic reactions similar to those from other drugs in its class. Chemotherapy can lead to fatigue, nausea, diarrhea, low blood cell counts increasing infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My liver cancer has been surgically removed and there's no sign of cancer elsewhere.

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My colorectal cancer has spread to my liver and there's no sign it has spread elsewhere.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 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

to determine if panitumumab with Hepatic Arterial Infusion (HAI) in combination with systemic chemotherapy can increase the recurrence free survival (RFS) for colorectal cancer patients with resected liver metastases

Secondary outcome measures

to analyze tumor tissue for predictive biomarkers

to assess toxicity as per the NCI Common Toxicity Criteria

to determine survival

Side effects data

From 2017 Phase 3 trial • 320 Patients • NCT00820248

94%

Dysphagia

92%

Acne

92%

Dry mouth

87%

Taste alteration

80%

Weight loss

77%

Fatigue

75%

Mucositis (clinical exam) Oral cavity

71%

Constipation

59%

Nausea

54%

Pain Throat/pharynx/larynx

50%

Dermatitis Chemoradiation

47%

Voice changes

45%

Dermatitis Radiation

43%

Anorexia

42%

Salivary gland changes

42%

Edema: head and neck

40%

Vomiting

37%

Dry skin

35%

Mucositis (functional/symptomatic) Oral cavity

33%

Mucositis (clinical exam) Pharynx

31%

Alopecia

30%

Heartburn

29%

Insomnia

28%

Pain Oral cavity

25%

Diarrhea

25%

Infection - Other

24%

Dehydration

24%

Cough

22%

Dermatology - Other

21%

Pain Head/headache

21%

Lymphopenia

21%

Hyperpigmentation

20%

Mood alteration Anxiety

20%

Edema, larynx

18%

Pain Middle ear

18%

Pain - Other

18%

Pain Neck

16%

Hand-foot

15%

Neuropathy-sensory

14%

Rigors/chills

14%

Hypothyroidism

14%

Trismus

14%

Hypertension

13%

Hearing (without monitoring program)

11%

Fibrosis-deep connective tissue

11%

Fever

11%

Pruritus

11%

Tinnitus

11%

Pain Tumor pain

10%

GI - Other

10%

Dyspnea

Pain Abdomen NOS

Mood alteration Depression

Rash

Muscle weakness Whole body/generalized

Pain Back

Hypopigmentation

Infection with normal ANC Catheter-related

Induration

Telangiectasia

Chelitis

Pain Bone

Pain Joint

Sweating

Dry eye

Osteonecrosis

Dizziness

Pain External ear

Neuropathy-motor

Teeth

Edema: limb

Hearing (monitoring program)

Hiccoughs

Pain Extremity-limb

100%

80%

60%

40%

20%

Study treatment Arm

Panitumumab

Cisplatin

Trial Design

2Treatment groups

Experimental Treatment

Group I: Randomization to panitumumabExperimental Treatment1 Intervention

Patients whose liver metastases have been completely resected will be randomized Arm A will receive Panitumumab in addition to HAI FUDR/Dexamethasone plus systemic CPT-11/5FU/LV

Group II: Randomization to No PanitumumabExperimental Treatment1 Intervention

Patients whose liver metastases have been completely resected will be randomized and patients randomized to Arm B will receive HAI FUDR/Dex plus systemic CPT-11/5FU/LV alone.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

panitumumab

2010

Completed Phase 3

~1200

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,933 Previous Clinical Trials

585,547 Total Patients Enrolled

AmgenIndustry Sponsor

1,370 Previous Clinical Trials

1,377,613 Total Patients Enrolled

Nancy Kemeny, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

2 Previous Clinical Trials

87 Total Patients Enrolled

Media Library

panitumumab Clinical Trial Eligibility Overview. Trial Name: NCT01312857 — Phase 2

Colorectal Cancer Research Study Groups: Randomization to panitumumab, Randomization to No Panitumumab

Colorectal Cancer Clinical Trial 2023: panitumumab Highlights & Side Effects. Trial Name: NCT01312857 — Phase 2

panitumumab 2023 Treatment Timeline for Medical Study. Trial Name: NCT01312857 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there notable precedents for research using panitumumab?

"As of now, 33 distinct medical studies are being conducted with panitumumab. Three of those trials have reached the third phase and can be found in Nagoya-shi, Aichi, however there exists a total 561 clinical trial sites testing this drug's efficacy."

Answered by AI

How many subjects does this trial have capacity for?

"This experiment has since ceased its recruitment process, with the most recent update to their record taking place on April 1st 2022. Alternatively, there are 876 studies connected to colorectal cancer and 33 trials leveraging panitumumab that remain active in terms of recruiting patients."

Answered by AI

Has panitumumab achieved regulatory approval yet?

"Although there is evidence that panitumumab may be safe, due to it being a Phase 2 trial with no efficacy data available, our team at Power estimated the safety of this medication as a level 2."

Answered by AI

Is this the inaugural clinical trial of its kind?

"Currently, 33 ongoing clinical trials for panitumumab are taking place in 141 cities and 15 countries since its initial study by Amgen back in 2011 which involved 75 participants and culminated at the Phase 2 drug approval stage. Since then 101 studies have been completed."

Answered by AI

How many healthcare centers are participating in this experimental study?

"Memorial Sloan Kettering Basking Ridge in Basking Ridge, Memorial Sloan Kettering Westchester in Harrison and Memorial Sloan Kettering Nassau in Uniondale are amongst the 8 medical sites that are actively participating in this clinical trial."

Answered by AI

Are there any open slots left in this experiment for participants?

"According to records posted on clinicaltrials.gov, this medical trial has concluded its recruitment phase and is no longer searching for patients. This study was initially announced in March 2011 with updates released April 2022; however, 909 other trials are currently accepting applicants at present."

Answered by AI