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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
Maastricht Radiation Oncology
ClinicalTrials.gov Identifier:
NCT00181532
First received: September 13, 2005
Last updated: June 29, 2009
Last verified: June 2009
  Purpose

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.


Condition Intervention Phase
Non Small Cell Lung Carcinoma
Drug: Celecoxib
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Multicentre Randomised Double Blind Placebo-Controlled Phase II Study of Celecoxib and Concurrent Radiotherapy in Stage II-III NSCLC. An Evaluation of Both Tumor Radiosensitization and Normal Tissue Protection

Resource links provided by NLM:


Further study details as provided by Maastricht Radiation Oncology:

Primary Outcome Measures:
  • tumor response rate

Secondary Outcome Measures:
  • local progression free survival 9 months after radiotherapy
  • radiopneumonitis
  • lung fibrosis,6 month post radiotherapy
  • acute esophagitis
  • quality of life
  • survival after 1 year
  • survival after 2 years

Estimated Enrollment: 102
Study Start Date: May 2003
Study Completion Date: January 2008
Detailed Description:

Treatment of non-small cell lung cancer (NSCLC) is difficult, even with the best classical radiation and chemotherapy schedule results remain disappointing. However, there is evidence that increasing the local control rate by delivering radiotherapy either in a short period of time or concomitantly with chemotherapy improves survival. Drawback of a higher radiation dose or addition of chemotherapy is a higher incidence of toxicity. So radiation dose escalation could lead to further improvements of prognosis, but the radiation dose is however limited by radiation-induced lung and esophageal damage.

For NSCLC, non-toxic agents who both increase the effectiveness of radiotherapy and decrease radiation induced lung and esophageal damage are needed. The cox-2-inhibitors seem to be suitable for this purpose. In experimental mice tumor models, it was already shown that COX-2-inhibitors both inhibit tumor growth and enhance the radio-response of the tumor. Moreover, anti-inflammatory agents, such asCOX-2-inhibitors, also lowered the incidence of radiation pneumonitis and esophagitis.

In this study the simultaneous favourable effects of COX-2 inhibitors on tumor response and radiation damage in human cancer patients will be investigated.

Patients will be randomised to receive Celecoxib or placebo. All patients will receive the same radiotherapy treatment. Primary outcome measure is tumor response, assessed by a CT-scan of the thorax, three months after radiotherapy.

The tumor response rate of the experimental group will be compared to the tumor response rate of the control group.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00181532

Locations
Netherlands
Maastircht Radiation Oncology
Heerlen, Limburg, Netherlands, 6411 PC
Sponsors and Collaborators
Maastricht Radiation Oncology
Pfizer
Investigators
Principal Investigator: Dirk De Ruysscher, PHD Maastricht Radiation Oncology (MAASTRO-clinic)
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00181532     History of Changes
Other Study ID Numbers: P02.1376L, CKTO 2003-07, IKL 2003-02, MEC MAASTRO 0205
Study First Received: September 13, 2005
Last Updated: June 29, 2009
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht Radiation Oncology:
NSCLC
cox-2-inhibitor
radiosensitizer
radiotherapy

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Celecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Central Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on April 15, 2014