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

Sponsors and Collaborators:	Maastricht Radiation Oncology Pfizer
Information provided by:	Maastricht Radiation Oncology
ClinicalTrials.gov Identifier:	NCT00181532

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 II

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Celecoxib 4-(5-(4-Methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl)benzenesulfonamide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
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

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, Limburg
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

Study ID Numbers:	P02.1376L, CKTO 2003-07, IKL 2003-02, MEC MAASTRO 0205
Study First Received:	September 13, 2005
Last Updated:	May 28, 2008
ClinicalTrials.gov Identifier:	NCT00181532
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht Radiation Oncology:

NSCLC
cox-2-inhibitor
radiosensitizer
radiotherapy

Study placed in the following topic categories:

Thoracic Neoplasms
Non-small cell lung cancer
Celecoxib
Respiratory Tract Diseases
Lung Neoplasms

Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Pharmacologic Actions
Neoplasms

Neoplasms by Site
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009