Radiation Plus Cetuximab in Locally Advanced Non-Small Cell Lung Cancer (NSCLC)

This study has been completed.
Sponsor:
Information provided by:
Heidelberg University
ClinicalTrials.gov Identifier:
NCT00115518
First received: June 22, 2005
Last updated: August 3, 2011
Last verified: February 2011
  Purpose

The purpose of this trial is to study combined locoregional radiotherapy with cetuximab in non-operable NSCLC Stage III (Phase II trial).

Endpoints:

safety and feasibility (primary) response, survival, time to progression (secondary)


Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung
Drug: cetuximab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Locoregional Radiotherapy in Combination With Cetuximab in Inoperable Non-Small Cell Lung Cancer Stage III

Resource links provided by NLM:


Further study details as provided by Heidelberg University:

Primary Outcome Measures:
  • safety: rate of side effects (skin reactions, allergic reactions, decrease of pulmonary function) [ Time Frame: 3 yrs ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • response (RECIST criteria of primary tumor and enlarged lymphnodes) [ Time Frame: 3 yrs ] [ Designated as safety issue: No ]
  • survival (at 3 years) [ Time Frame: 3 yrs ] [ Designated as safety issue: No ]
  • time to progression (locally and systemically) [ Time Frame: 3 yrs ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: May 2005
Study Completion Date: August 2010
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: cetuximab
    After Cetuximab loading dose. weekly cetuximab during RT. 13 weeks cetuximab weekly maintenance
Detailed Description:

Study entry examinations:

  • blood cell count
  • liver enzymes
  • ventilatory function test
  • pregnancy test (premenopausal women)
  • CT of the thorax
  • CT of the brain
  • Ultrasound of the liver
  • Bone scan
  • FDG PET scan (after inclusion)

Follow-up examinations (2 months, than every 3 months):

  • patients history and examination
  • CT scan of the thorax
  • ventilatory functions test
  • FDG PET scan (at least at 6 months)
  • bone scan (yearly)
  • ultrasound of the liver (every 6 months)

Cetuximab administration:

  • 450 mg / m^2 body surface on week 1
  • 250 mg /m^2 body surface weekly, week 2 -21

Radiation therapy:

  • intensity modulated radiation therapy of primary tumor and mediastinum (2 Gy single dose, total dose 50 Gy; 5 fractions per week) with boost to the PET positive sites (2 Gy single doses up to 66 Gy). Radiation therapy during weeks 2-8.

Amendment 1/07: 3D conformal RT possible, but not if FeV1 < 1.5L of < 50%

  Eligibility

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

Inclusion Criteria:

  • Histologically verified NSCLC
  • Not eligible for Radiochemotherapy or patient refuses chemotherapy
  • FeV1 >1.5 L or min. 50%
  • KPI >= 70%
  • Life expectancy > 6 months
  • Weight loss less than 10% of body weight in 12 months
  • Compliance
  • Adequate blood counts (LC > 3000 x 10^3/ml, Tc >100000 x 10^3/ml, Hb > 10 g/dl)
  • Effective contraception

Amendment 1/07: FeV1 >1.2 L or min 40%

Exclusion Criteria:

  • Active infection
  • Reduced liver function
  • Vena cava superior syndrome
  • Malignant pleural effusion
  • Pregnancy or breast feeding
  • Additional serious systemic disease
  • Secondary malignancy (except carcinoma in situ of the cervix, basalioma of the skin, secondary cancer in remission for > 5 years)
  • Known allergies against proteins
  • History of former antibody therapy
  • Allergy against i.v. contrast agents
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00115518

Locations
Germany
University of Heidelberg
Heidelberg, Germany, 69120
Sponsors and Collaborators
Heidelberg University
Investigators
Principal Investigator: Klaus K Herfarth, MD Heidelberg University
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Klaus Herfarth, MD, UJniversity of Heidelberg
ClinicalTrials.gov Identifier: NCT00115518     History of Changes
Other Study ID Numbers: NEAR L-284/2004
Study First Received: June 22, 2005
Last Updated: August 3, 2011
Health Authority: Germany: Paul-Ehrlich-Institut
Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Cetuximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 16, 2014