Zalutumumab in Combination With Radiotherapy in Head and Neck Cancer Patients Ineligible for Platinum Based Chemotherapy

NCT00707655 | Terminated Phase 1 Results DMC

• 1 other identifier: GEN207
• Study Type: interventional
• Target: 8
• Locations: 3 countries
• Sites: 8

Brief Summary

The purpose of this study is to investigate the safety of zalutumumab in combination with radiotherapy as the treatment of patients with head and neck cancer who are not eligible for platinum based chemotherapy.

Conditions

Head and Neck Cancer; Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events (AEs)

  Number of participants with at least one adverse event. All adverse events are collected during 12 weeks and all serious adverse events are collected during 2 years.

  From first dose date up to end of the safety follow up period (Up to 2 years)

Secondary Outcomes (2)

• Number of Participants With Best Overall Tumour Response

  Up to 2 years

• Number of Participants With Objective Response

  Up to 2 years

Study Arms (2)

Zalutumumab 4 mg/kg

EXPERIMENTAL

Zalutumumab in combination with radiotherapy for 8 weeks. The treatment period of 8 weeks is followed by a 3 week follow-up period where all adverse events are collected and then additionally a 2 year follow-up period where only serious adverse events are collected.

Drug: Zalutumumab

Zalutumumab 8 mg/kg

EXPERIMENTAL

Zalutumumab in combination with radiotherapy for 8 weeks. The treatment period of 8 weeks is followed by a 3 week follow-up period where all adverse events are collected and then additionally a 2 year follow-up period where only serious adverse events are collected.

Drug: Zalutumumab

Interventions

Zalutumumab DRUG

Eight weekly infusions

Zalutumumab 4 mg/kg; Zalutumumab 8 mg/kg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with histologically or cytologically confirmed diagnosis of locally advanced squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx stage III, IVa or IVb
• Measurable disease defined as one or more target lesions according to RECIST based onCT scan or MRI and clinical evaluation
• Eligible for intended curative radiotherapy
• Patients considered ineligible for platinum based chemotherapy based on investigator's judgment
• Age \> 18 years
• Following receipt of verbal and written information about the study, the patient must provide signed informed consent before any study related activity is carried out

You may not qualify if:

• Prior radiotherapy to the head and neck area
• Prior chemotherapy administered for cancer in the head and neck area
• Prior targeted therapy (e.g. EGFR antibodies or EGFR inhibitors)
• Received the following treatments within 4 weeks prior to Visit 2:
• Retinoic acid
• Other immunosuppressive drugs (e.g. drugs interfering with the functions of T cells, IL-2 or equivalent)
• Any non-marketed drug substance
• Past or current malignancy other than SCCHN, except for:
• Cervical carcinoma Stage 1B or less
• Non-invasive basal cell skin carcinoma
• Squamous cell skin carcinoma
• Stage 1 or 2 treated prostate cancer with PSA in the normal range for \>2 years post treatment
• Malignant melanoma with a complete response duration of \> 10 years
• Other cancer diagnoses with a complete response duration of \> 5 years
• Metastatic SCCHN disease

Sponsors & Collaborators

• Genmab: lead

Study Sites (8)

St-Luc University Hospital

Brussels, Belgium

Location

Centre Georges-Francois Leclerc Hospital

Dijon, France

Location

Medical Oncology, Outpatient Clinic

Nantes, France

Location

Institut Claudius Regaud Toulouse

Toulouse, France

Location

St James's Institute of Oncology

Leeds, LS9 7TF, United Kingdom

Location

The Royal Marsden NHS Foundation Trust

London, United Kingdom

Location

Christie Hospital NHS Foundation Trust

Manchester, United Kingdom

Location

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, United Kingdom

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Carcinoma, Squamous Cell

Interventions

zalutumumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Limitations and Caveats

All adverse events were collected during the 8 week treatment period and for 4 additional weeks. Serious adverse events were collected for the extended follow-up period of 2 years.

Results Point of Contact

• Title: Eva Järlid Westerberg, VP Clinical Operations
• Organization: Genmab A/S

E.Westerberg@genmab.com

+45 7020 2728

Study Officials

• Philippe MAIGON

  Centre Georges François Leclerc

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2008
• First Posted: July 1, 2008
• Study Start: September 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: August 3, 2023
• Results First Posted: December 23, 2011

Record last verified: 2023-08

Locations

FR (3); GB (4); BE (1)