Status:
UNKNOWN
Effect of Celecoxib on Survival in Patients With Advanced Non-Small Cell Lung Cancer Receiving Chemotherapy
Lead Sponsor:
University Hospital, Linkoeping
Collaborating Sponsors:
Swedish Lung Cancer Study Group
Pfizer
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The primary purpose of the study is to investigate if daily treatment with celecoxib, an inhibitor of cyclooxygenase-2, can prolong survival in patients with advanced non-small cell lung cancer who re...
Detailed Description
The study (CYCLUS trial, CY-cyclooxygenase-2 inhibitor, Chemotherapy, LUng cancer, Survival) is a prospective randomized double-blind multicenter trial. Patients are randomized to receive celecoxib at...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC).
- Age at least 18 years. No upper age limit.
- Disease stage IIIB or IV.
- Performance status (WHO) 0-2
- Treatment with curative intent is not possible
- No prior chemotherapy for the present disease
- Planned treatment is palliative chemotherapy
- WBC count at least 3.0, platelet count at least 100
- Bilirubin \< 1.5 \* upper reference limit (URL), ASAT and ALAT \< 3 \* URL (\<5 in case of liver metastases)
- Calculated creatinine clearance at least 40 mg/ml
- Informed oral and written consent
- Exclusion criteria:
- Regular use of NSAID (except ASA at a dose of 50-100 mg daily)
- Active duodenal ulcer, ongoing gastrointestinal bleeding or inflammatory bowel disease
- Serious heart failure or serious liver disease
- Hypersensitivity so sulfonamides
- Pregnancy
- Lactation
Exclusion
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
319 Patients enrolled
Trial Details
Trial ID
NCT00300729
Start Date
May 1 2006
End Date
September 1 2010
Last Update
June 30 2009
Active Locations (13)
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1
Department of Pulmonary Medicine and Allergology, Sahlgrenska University Hospital
Gothenburg, Sweden, 413 45
2
Section of Pulmonary Medicine, Ryhov County Hospital
Jönköping, Sweden, 551 85
3
Section of Pulmonary Medicine and Allergology, County Hospital of Kalmar
Kalmar, Sweden, 391 85
4
Department of Pulmonary Medicine, University Hospital
Linköping, Sweden, 581 85