Adjuvant Celecoxib in Completely Resected pN1-2 NSCLC Patients

NCT00211952 | Suspended Phase 3

• 1 other identifier: 0102 PLCSG
• Study Type: interventional
• Target: 542
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• time to progression

Secondary Outcomes (2)

• overall survival

• toxicity

Interventions

celecoxib DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Medical University of Gdansk: lead
• Central and Eastern European Oncology Group: collaborator
• Stowarzyszenie Ludzi Wyleczonych z Raka Płuca: collaborator
• Pharmacia: collaborator

Study Sites (1)

Medical University of Gdansk

Gdansk, 80-211, Poland

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jacek Jassem, Professor

  Medical University of Gdansk

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: March 1, 2004
• Last Updated: September 21, 2005

Record last verified: 2005-09

Locations

PL (1)