Cetuximab for Chordoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Chordoma+2 MoreCetuximab - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug to treat chordoma, a type of cancer. The target patient population is any chordoma patient 18 years of age with locally unresectable disease or metastatic disease.

Eligible Conditions
  • Chordoma
  • Metastatic Chordoma
  • Unresectable Chordoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: through study completion, an average of 1 year

Year 1
Overall response rate

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Cetuximab + Cisplatin + 5-FU : Treatment Emergent Phase
43%Leucopenia
43%Weight Decreased
40%Nausea
35%Rash
34%Hypomagnesaemia
32%Hypokalemia
31%Constipation
28%Neutropenia
28%Vomiting
26%Decreased Appetite
22%Pyrexia
19%Hyponatremia
19%Hemoglobin Decreased
19%Acne
18%Diarrhea
18%Stomatitis
15%Fatigue
15%Pruritus
13%Mucosal Inflammation
13%Neutrophil Count Decreased
12%Mouth Ulceration
10%Thrombocytopenia
10%Asthenia
10%Insomnia
9%Cough
9%White Blood Cell Count Decreased
9%Dizziness
7%Abdominal Pain Upper
7%Aspartate Aminotransferase Increased
7%Paronychia
7%Hypochloremia
7%Weight Increased
7%Hypocalcaemia
7%Dermatitis Acneiform
6%Oral Pain
6%Headache
6%Neck pain
6%Dyspnoea
3%Anaphylactic reaction
1%Pulmonary embolism
1%Toxic encephalopathy
1%Myocardial infarction
1%Staphylococcal skin infection
1%Microcytic anemia
1%Electrolyte imbalance
1%Tumor hemorrhage
1%Pneumonia
1%Mouth hemorrhage
1%Pneumonitis
1%Venous thrombosis
1%Respiratory alkalosis
This histogram enumerates side effects from a completed 2012 Phase 3 trial (NCT01177956) in the Cetuximab + Cisplatin + 5-FU : Treatment Emergent Phase ARM group. Side effects include: Leucopenia with 43%, Weight Decreased with 43%, Nausea with 40%, Rash with 35%, Hypomagnesaemia with 34%.

Trial Design

1 Treatment Group

Treatment (cetuximab)
1 of 1

Experimental Treatment

15 Total Participants · 1 Treatment Group

Primary Treatment: Cetuximab · No Placebo Group · Phase 2

Treatment (cetuximab)Experimental Group · 2 Interventions: Cetuximab, Questionnaire Administration · Intervention Types: Biological, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cetuximab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, an average of 1 year

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,805 Previous Clinical Trials
1,790,364 Total Patients Enrolled
2 Trials studying Chordoma
83 Patients Enrolled for Chordoma
Anthony P ConleyPrincipal InvestigatorM.D. Anderson Cancer Center
Anthony P Conley, MDPrincipal InvestigatorM.D. Anderson Cancer Center

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a histologically confirmed diagnosis of chordoma which is advanced (unresectable) and/or metastatic.
Patients may have any prior line of therapy, but there should a washout period of at least 3 weeks from any systemic therapy (small molecule/targeted agents, immunotherapies) and/or radiation therapy.
You are recovering from any prior therapy.
A new tumor related biopsy should be considered within acceptable risk to the patient.
At least one site of measurable disease on x-ray/CT/MRI and/or PET/CT scan as defined by RECIST 1.1 criteria