Zalutumumab in Combination With Chemo-Radiation in a Certain Type of Lung Cancer

This study has been terminated.
(Due to considerations regarding the appropriate therapeutic regimen for these patients.)
Sponsor:
Information provided by (Responsible Party):
Genmab
ClinicalTrials.gov Identifier:
NCT00460551
First received: April 12, 2007
Last updated: December 5, 2011
Last verified: December 2011
  Purpose

The purpose of the study is to investigate if treatment with zalutumumab in combination with chemotherapy and radiotherapy (chemo-radiation) will lead to a prolonged life in patients with lung cancer compared to patients treated with chemo-radiation alone.


Condition Intervention Phase
Non Small Cell Lung Cancer
Biological: Zalutumumab
Drug: Induction chemotherapy
Radiation: Radiotherapy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Multi-center Trial Investigating Zalutumumab, a Human Monoclonal Anti-EGF Receptor Antibody, in Combination With Chemo-Radiation in Stage IIIA-IIIB Non Small Cell Lung Cancer Patients

Resource links provided by NLM:


Further study details as provided by Genmab:

Primary Outcome Measures:
  • Progression Free Survival Verified by Imaging Techniques. [ Time Frame: Until disease progression ] [ Designated as safety issue: No ]
    Disease progression was planned to be confirmed using RECIST criteria J Natl Cancer Inst 2000;92:205-16


Secondary Outcome Measures:
  • Adverse Events [ Time Frame: Up to 3 months ] [ Designated as safety issue: No ]
    Number of participants reporting at least one adverse event


Enrollment: 13
Study Start Date: April 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Zalutumumab 8 mg/kg Biological: Zalutumumab
8 mg/kg
Drug: Induction chemotherapy
Combination of cisplatin and docetaxel administered as two cycles given every three weeks
Radiation: Radiotherapy
64 Gy in 32 fractions over 6.5 weeks

Detailed Description:

Originally the study was planned as Part 1A, Part 1B and Part 2. Part 1A was one arm with zalatumumab fixed dose 8 mg/kg. Part 1B was planned as zalutumumab dose-titration and Part 2 adding a comparator. The trial was prematurely closed for enrolment when patients had only been enrolled in Part 1A due to published results showing increased toxicity from induction chemotherapy without any survival benefit.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • NSCLC stage IIIA-IIIB
  • Performance status 0 or 1 (Zubrod or WHO Scale)

Exclusion Criteria:

  • Evidence of metastases either in a separate lobe of the lung, or extra thoracic
  • Patients with high risk of radiation pneumonitis and or compromised lung function
  • Estimated life expectancy of less than 3 months
  • Prior chemotherapy for lung cancer
  • Prior radiotherapy to the chest
  • Prior surgery with curative intent for lung cancer
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00460551

Locations
United States, Maryland
Towson, Maryland, United States, 21204
United States, Oregon
Providence Portland Medical Center
Portland, Oregon, United States, 97213-2967
Belgium
UZ Gent
Gent, Belgium, 9000
CHU Sart-Tilman Domaine Universitaire du Sart-Tilman
Liege, Belgium, 4000
CHR La Citadelle
Liege, Belgium, 4000
France
CHRU Reims, Hospital Maison Blanche
Reims, Cedex, France, 51092
Netherlands
VU Medisch Centrum (VUMC)
Amsterdam, Netherlands, 1004MB
United Kingdom
The Institute of Cancer Research and the Royal Marsden NHS Foundation Trust
Sutton, Surrey, United Kingdom, SM2 5PT
Sponsors and Collaborators
Genmab
Investigators
Study Director: Steen Lisby, MD, PHD Genmab employee
  More Information

No publications provided

Responsible Party: Genmab
ClinicalTrials.gov Identifier: NCT00460551     History of Changes
Other Study ID Numbers: GEN204
Study First Received: April 12, 2007
Results First Received: September 12, 2011
Last Updated: December 5, 2011
Health Authority: United States: Food and Drug Administration
Germany: Paul-Ehrlich-Institut
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 14, 2014