Adjuvant Celecoxib in Completely Resected pN1-2 NSCLC Patients

This study has suspended participant recruitment.
Sponsor:
Collaborators:
Central and Eastern European Oncology Group
Stowarzyszenie Ludzi Wyleczonych z Raka Płuca
Pharmacia
Information provided by:
Medical University of Gdansk
ClinicalTrials.gov Identifier:
NCT00211952
First received: September 13, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

The aim of the study is to assess the influence of celecoxib on relapse-free survival in completely resected patients with poor prognosis indicated by metastatic involvement of intrapulmonary/hilar (pN1) or ipsilateral mediastinal (pN2) lymph nodes. Celecoxib, a selective oral COX-2 inhibitor, was found to exert significant anti-proliferative activity against a variety of tumor cell lines in vitro, including NSCLC. COX-2 is frequently up-regulated in NSCLC cell lines and archival tumor samples. Its high expression was also correlated with poor prognosis of the patients. A clinical trial addressing the role of celecoxib as adjuvant treatment in radically operated patients with high risk of relapse is warranted.


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: celecoxib
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Placebo Controlled Phase III Trial Evaluating the Role of Adjuvant Celecoxib in Completely Resected, High-Risk (pN1-2) Non-Small Cell Lung Cancer (NSCLC) Patients

Resource links provided by NLM:


Further study details as provided by Medical University of Gdansk:

Primary Outcome Measures:
  • time to progression

Secondary Outcome Measures:
  • overall survival
  • toxicity

Estimated Enrollment: 542
Study Start Date: March 2004
  Show Detailed Description

  Eligibility

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

Eligibility criteria:

  • Completely resected (R0), histologically confirmed NSCLC with pathological T1-T3 category and pathological proof of N1 or N2 disease
  • Adequate pre-surgical disease assessment (chest CT and upper abdominal CT – mandatory; mediastinoscopy or PET mandatory if clinical N2 is suspected on chest CT; other examinations according to signs and symptoms to exclude metastatic disease)
  • Adequate lymph node sampling
  • Randomization between 14 and 42 days after surgery
  • Adequate post-surgical recovery
  • Age > 18 years
  • WHO Performance Status 0 or 1
  • Adequate liver and renal function (ALT < 1.5 ULN, bilirubin within normal limits, creatinine < 1.5 ULN) and adequate haematology (haemoglobin >11g/dL, WBC>2.000/L, PLT>100.000/L)
  • Written informed consent
  • No previous treatment with chemotherapy
  • No histological diagnosis of SCLC or mixed NSCLC/SCLC type
  • No apparent involvement of mediastinal lymph nodes at preoperative staging (cN2)
  • No evidence of metastatic disease (M1)
  • Stable medical conditions (e.g. no myocardial infarction within 12 months, unstable angina, active psychiatric disorder)
  • No active infection
  • No history of malignancy other than basal-cell skin cancer or in situ cervical cancer
  • No history of severe renal or liver insufficiency
  • No history of a recent gastrointestinal bleeding or active ulcer disease or extensive gastro-intestinal surgery that may affect the drug absorption
  • No participation in any investigational study within 30 days prior to enrollment
  • No pregnancy or lactation or inadequate contraception
  • No known hypersensitivity to celecoxib, other COX-2 inhibitors or aspirin (aspirin triad)
  • No chronic use of NSAID’s (selective inhibitors of COX-2 and non- selective COX inhibitors), acetylsalicylic acid (aspirin) nor oral steroids >14 days during one month prior to surgery nor anticipated chronic use of the above drugs during the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00211952

Locations
Poland
Medical University of Gdansk
Gdansk, Poland, 80-211
Sponsors and Collaborators
Medical University of Gdansk
Central and Eastern European Oncology Group
Stowarzyszenie Ludzi Wyleczonych z Raka Płuca
Pharmacia
Investigators
Principal Investigator: Jacek Jassem, Professor Medical University of Gdansk
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00211952     History of Changes
Other Study ID Numbers: 0102 PLCSG
Study First Received: September 13, 2005
Last Updated: September 13, 2005
Health Authority: Poland: Ministry of Health

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
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 17, 2014