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Zalutumumab in Combination With Chemotherapy and Radiotherapy in Head and Neck Cancer

An Open-labeled Trial With a Dose-escalation Part and a Parallel Group Design(1) Investigating Zalutumumab, an Anti-EGF Receptor Antibody, in Combination With Chemo-Radiation as First Line Treatment of Patients With Cancer of the Head and Neck (1) The Parallel Group Part Was Cancelled

Status
Terminated
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00401401
Enrollment
30
Registered
2006-11-20
Start date
2006-12-31
Completion date
2010-10-31
Last updated
2011-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer, Squamous Cell Cancer

Brief summary

The purpose of this study is to investigate the safety of zalutumumab in combination with chemotherapy and radiotherapy as treatment of patients with head and neck cancer

Interventions

DRUGzalutumumab

Eight weekly infusions

DRUGcisplatin

Infusions

PROCEDURERadiotherapy

Daily in the treatment period

Sponsors

Genmab
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients with locoregionally advanced squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx

Exclusion criteria

* Prior treatment with radiotherapy in the head and neck area * Prior treatment with chemotherapy * Prior treatment with similar drugs (e.g. EGFr antibodies, EGFr inhibitors) * Previous surgery with curative intent for head and neck cancer

Design outcomes

Primary

MeasureTime frameDescription
Adverse EventsOverall StudyNumber of participants with at least one adverse event. All adverse events were collected during the 8 week treatment period and the following 4 weeks. Serious adverse events were collected during 3 years after the patient was allocated to the trial.

Secondary

MeasureTime frameDescription
Overall ResponseUp to 3 yearsTumour response according to RECIST criteria J Natl Cancer Inst 2000;92:205-16 assessed by CT/MRI. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the longest diameter of target lesions; Overall Response (OR), CR+PR
Time to ResponseUp to 3 yearsTumour response according to RECIST criteria J Natl Cancer Inst 2000;92:205-16 assessed by CT/MRI. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the longest diameter of target lesions; Overall Response (OR), CR+PR
Best Overall Tumor ResponseUp to 3 yearsTumour response according to RECIST criteria J Natl Cancer Inst 2000;92:205-16 assessed by CT/MRI. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the longest diameter of target lesions; Overall Response (OR), CR+PR

Countries

Belgium, France, Netherlands, Sweden, United States

Participant flow

Participants by arm

ArmCount
Zalutumumab 4 mg/kg
Zalutumumab 8 weekly infusions
6
Zalutumumab 8 mg/kg
Zalutumumab 8 weeky infusions
6
Zalutumumab 12 mg/kg
Zalutumumab 8 weekly infusions
6
Zalutumumab 16 mg/kg
Zalutumumab 8 weekly infusions
12
Total30

Baseline characteristics

CharacteristicZalutumumab 4 mg/kgZalutumumab 8 mg/kgZalutumumab 12 mg/kgZalutumumab 16 mg/kgTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
6 Participants6 Participants6 Participants12 Participants30 Participants
Age Continuous58 years54 years49 years52 years52 years
Region of Enrollment
Belgium
4 participants4 participants3 participants6 participants17 participants
Region of Enrollment
France
0 participants0 participants1 participants3 participants4 participants
Region of Enrollment
Sweden
2 participants2 participants2 participants2 participants8 participants
Region of Enrollment
United States
0 participants0 participants0 participants1 participants1 participants
Sex: Female, Male
Female
3 Participants1 Participants2 Participants1 Participants7 Participants
Sex: Female, Male
Male
3 Participants5 Participants4 Participants11 Participants23 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —
other
Total, other adverse events
6 / 66 / 66 / 612 / 12
serious
Total, serious adverse events
5 / 66 / 65 / 611 / 12

Outcome results

Primary

Adverse Events

Number of participants with at least one adverse event. All adverse events were collected during the 8 week treatment period and the following 4 weeks. Serious adverse events were collected during 3 years after the patient was allocated to the trial.

Time frame: Overall Study

ArmMeasureValue (NUMBER)
Zalutumumab 4 mg/kgAdverse Events6 participants
Zalutumumab 8 mg/kgAdverse Events6 participants
Zalutumumab 12 mg/kgAdverse Events6 participants
Zalutumumab 16 mg/kgAdverse Events12 participants
Secondary

Best Overall Tumor Response

Tumour response according to RECIST criteria J Natl Cancer Inst 2000;92:205-16 assessed by CT/MRI. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the longest diameter of target lesions; Overall Response (OR), CR+PR

Time frame: Up to 3 years

ArmMeasureGroupValue (NUMBER)
Zalutumumab 4 mg/kgBest Overall Tumor ResponseProgressive disease0 Participants
Zalutumumab 4 mg/kgBest Overall Tumor ResponsePartial response5 Participants
Zalutumumab 4 mg/kgBest Overall Tumor ResponseNonevaluable0 Participants
Zalutumumab 4 mg/kgBest Overall Tumor ResponseStable disease0 Participants
Zalutumumab 4 mg/kgBest Overall Tumor ResponseComplete response1 Participants
Zalutumumab 8 mg/kgBest Overall Tumor ResponseStable disease2 Participants
Zalutumumab 8 mg/kgBest Overall Tumor ResponseProgressive disease0 Participants
Zalutumumab 8 mg/kgBest Overall Tumor ResponseNonevaluable0 Participants
Zalutumumab 8 mg/kgBest Overall Tumor ResponsePartial response3 Participants
Zalutumumab 8 mg/kgBest Overall Tumor ResponseComplete response1 Participants
Zalutumumab 12 mg/kgBest Overall Tumor ResponseStable disease2 Participants
Zalutumumab 12 mg/kgBest Overall Tumor ResponseComplete response0 Participants
Zalutumumab 12 mg/kgBest Overall Tumor ResponsePartial response2 Participants
Zalutumumab 12 mg/kgBest Overall Tumor ResponseProgressive disease1 Participants
Zalutumumab 12 mg/kgBest Overall Tumor ResponseNonevaluable1 Participants
Zalutumumab 16 mg/kgBest Overall Tumor ResponseProgressive disease0 Participants
Zalutumumab 16 mg/kgBest Overall Tumor ResponsePartial response0 Participants
Zalutumumab 16 mg/kgBest Overall Tumor ResponseComplete response5 Participants
Zalutumumab 16 mg/kgBest Overall Tumor ResponseStable disease6 Participants
Zalutumumab 16 mg/kgBest Overall Tumor ResponseNonevaluable1 Participants
Secondary

Overall Response

Tumour response according to RECIST criteria J Natl Cancer Inst 2000;92:205-16 assessed by CT/MRI. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the longest diameter of target lesions; Overall Response (OR), CR+PR

Time frame: Up to 3 years

ArmMeasureValue (NUMBER)
Zalutumumab 4 mg/kgOverall Response6 Participants
Zalutumumab 8 mg/kgOverall Response4 Participants
Zalutumumab 12 mg/kgOverall Response2 Participants
Zalutumumab 16 mg/kgOverall Response5 Participants
Secondary

Time to Response

Tumour response according to RECIST criteria J Natl Cancer Inst 2000;92:205-16 assessed by CT/MRI. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the longest diameter of target lesions; Overall Response (OR), CR+PR

Time frame: Up to 3 years

Population: Number of months between date of first infusion and date of best response

ArmMeasureValue (MEDIAN)
Zalutumumab 4 mg/kgTime to Response5.79 months
Zalutumumab 8 mg/kgTime to Response3.98 months
Zalutumumab 12 mg/kgTime to Response4.31 months
Zalutumumab 16 mg/kgTime to Response5.80 months

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026