Adjuvant Celecoxib in Completely Resected pN1-2 NSCLC Patients

• Status: Suspended
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of Gdansk
• Collaborators: Central and Eastern European Oncology Group; Pharmacia; Stowarzyszenie Ludzi Wyleczonych z Raka Płuca
• Treatments: Celecoxib

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