Zalutumumab in Non-curable Patients With SCCHN

Phase 2CompletedNCT00542308

Genmab90 enrolled

Overview

Treatment, In combination with BSC, Open-label, Single arm, Efficacy Study.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Head and Neck Cancer Squamous Cell Cancer

Interventions

ZalutumumabDRUG

Individual dose titration weekly i.v. doses

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Males and females age ≥ 18 years 2. Confirmed diagnosis, initially or at relapse, of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx, considered incurable with standard therapy 3. Failure to at least one course of standard platinum-based chemotherapy Exclusion Criteria: 1. Three or more prior chemotherapy regimens 2. Prior treatment with EGFr antibodies and/or EGFr small molecule inhibitors 3. Past or current malignancy other than SCCHN, except for certain other cancer diseases

Locations (48)

Outcomes

Primary Outcomes

Overall Survival (OS)

OS was defined as time from start of treatment until date of death of any cause.

Time frame: From randomization until death, assessed up to 21 months

Secondary Outcomes

Objective Tumour Response

Objective Tumour response according to Response Evaluation Criteria in Solid Tumours (RECIST v 1.0). 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. Stable disease is Responses not fulfilling CR, PR or progressive disease (PD). PD is At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, OR the appearance of one or more new lesions.

Time frame: During treatment and two weeks after end of treatment, assessed up to 21 months.

Duration of Response

DOR is defined among responders, as the time from the initial documentation of response to the date of disease progression or death, whichever occurs earlier.

Time frame: During treatment and two weeks after end of treatment, assessed up to 21 months

Progression Free Survival (PFS)

PFS is defined as the time from start of treatment until disease progression or death.

Time frame: During treatment and two weeks after end of treatment, assessed up to 21 months

Data from ClinicalTrials.gov

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Loma Linda University Cancer Institute

Loma Linda, California, United States

Moffitt Cancer Center

Tampa, Florida, United States

Mountain States Tumor Institute

Boise, Idaho, United States

University Of Chicago Medical Center

Chicago, Illinois, United States

Ft. Wayne Medical Oncology/Hematology, Inc

Fort Wayne, Indiana, United States

Henry Ford Health Systems

Detroit, Michigan, United States

Oregon Health and Science University

Portland, Oregon, United States

Baylor University Medical Center

Dallas, Texas, United States

Medizinische Universität Graz

Graz, Austria

...and 38 more locations