Phase II Study of Celecoxib and Concurrent Radiotherapy in Stage II-III NSCLC

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate the effect of the adminstration of celecoxib, a cox2-inhibitor in patients with stage II-III non small cell lung cancer receiving radical radiotherapy.

The hypothesis is that celecoxib will increase the remission rate of radiotherapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Maastricht Radiation Oncology
• Collaborator: Pfizer
• Treatments: Celecoxib

Criteria

Inclusion Criteria:

• histologically proven non-small cell lung cancer

• UICC stage II-III

• WHO performance status 0-2

• less than 10% weight loss the last 6 month

• in case of previous chemotherapy, radiotherapy may start after a minimum of 21 days after the last chemotherapy course

• reasonable lung function: FEV1>30% of the predicted value

• no recent(<3month) severe cardiac disease

• no active peptic ulcer disease

• normal serum bilirubin

• normal serum creatinin

• life expectancy more than 6 month

• measurable cancer

• willing and able to comply with the study prescriptions

• able to give written informed consent before patient registration/randomisation

• no previous radiotherapy to the chest

Exclusion Criteria:

• not not small cell histology, e.g. mesothelioma, lymphoma

• mixed pathology, e.g. non small cell plus small cell cancer

• malignant pleural or pericardial effusion

• concurrent chemotherapy with radiation

• recent (<3month) myocardial infarction

• uncontrolled infectious disease

• distant metastases (stage IV)

• patients with active peptic ulceration or gastrointestinal bleeding in the last year

• patients with a past history of adverse reaction to NSAIDs

• renal disease

• chronic use of NSAIDs, COX-2 inhibitors or Aspirin in dosis >120mg/day.