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Effect of Celecoxib on Survival in Patients With Advanced Non-Small Cell Lung Cancer Receiving Chemotherapy

Information source: University Hospital, Linkoeping
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Non-Small Cell Lung Cancer

Intervention: Celecoxib (Drug); Placebo (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: University Hospital, Linkoeping

Official(s) and/or principal investigator(s):
Sverre Sörenson, MD, PhD, Study Chair, Affiliation: Department of Medicine, Ryhov County Hospital, Jönköping, Sweden, Department of Pulmonary Medicine, University Hospital, Linköping, Sweden, and Department of Medical and Health Sciences, Linköping University, Sweden
Andrea Koch, MD, Principal Investigator, Affiliation: Allergy Centre, University Hospital, Linköping, Sweden, Department of Pulmonary Medicine, University Hospital, Linköping, Sweden, and Department of Medical and Health Sciences, Linköping University, Sweden

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 receive anticancer chemotherapy as their primary treatment. Secondary endpoints of the study are: health-related quality of life, toxicity, cardiovascular events, progression-free survival, and biological markers (VEGF, proteomics).

Clinical Details

Official title: Cox-2-Inhibitor and Chemotherapy in Non-Small Cell Lung Cancer. A Prospective Randomized Double-Blind Study

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Overall survival

Secondary outcome:

Quality of life

Progression-free survival

Toxicity

Cardiovascular events

Biological parameters (plasma VEGF, proteomics)

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 a dose of 400 mg b. i.d. or placebo. Primary endpoint of the trial is survival. Secondary endpoints are: quality of life, progression-free survival, toxicity, cardiovascular events, and biological parameters (plasma VEGF and proteomics). The rationale behind the study consists of preclinical observations of antitumor effect of celecoxib in NSCLC. Inhibition of angiogenesis and proliferation as well as increased apoptosis has been demonstrated. In addition, pilot studies have shown that the combination of chemotherapy and celecoxib is feasible. No unexpected toxicity has been recorded in such trials. Furthermore, a randomized study of indomethacin, prednisolone or placebo in other types of advanced cancer, mainly gastrointestinal, showed a survival advantage for patients receiving antiinflammatory treatment. Chemotherapy is given according to the current standard of the participating institution. In practice, patients will usually receive either carboplatin + gemcitabine or carboplatin + vinorelbine. Treatment duration with chemotherapy is 4 cycles (cycle length 3 weeks) in the absence of tumour progression or prohibitive toxicity. Treatment with the study drug starts on the first day of cancer chemotherapy. Maximum treatment duration is one year. Treatment will be stopped earlier in case of objective tumor progression, serious toxicity that is considered to be related to the study drug or if the patient wants to stop treatment. The size of the study is based on the hypothesis that celecoxib could prolong median survival by 8 weeks as compared to 7. 5 months in the placebo group. With standard statistical requirements (type I error 5%, type II error 20%), the calculated number of patients was 760. The study was supported by the Swedish Lung Cancer Study Group and organized as a multicenter trial, with participation of seven university hospitals and six smaller hospitals. The number of new cases of NSCLC stage IIIB-IV and performance status 0-2 in Sweden is around 1200/year. It was expected that 20% of the patients could be included in the study, which would make completion possible in three years. The study was opened for randomization on May 31, 2006. Recruitment of patients was lower than expected. The study was closed for further randomization on May 31, 2009, as originally planned. 319 patients were included. Since maximum duration of treatment with the study drug is one year, the code will be broken after May 31, 2010. Data analysis is planned to take place in summer and autumn, 2010.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Department of Pulmonary Medicine and Allergology, Sahlgrenska University Hospital, Gothenburg 413 45, Sweden

Section of Pulmonary Medicine, Ryhov County Hospital, Jönköping 551 85, Sweden

Section of Pulmonary Medicine and Allergology, County Hospital of Kalmar, Kalmar 391 85, Sweden

Department of Pulmonary Medicine, University Hospital, Linköping 581 85, Sweden

Department of Pulmonary Medicine and Allergy, Lund University Hospital, Lund 221 85, Sweden

Section of Pulmonary Medicine, Malmö University Hospital, Malmö 205 02, Sweden

Department of Medicine, Skövde Hospital/KSS, Skövde 541 85, Sweden

Department of Medicine, Trollhättan Hospital/NÄL, Trollhättan 461 85, Sweden

Department of Medicine, Uddevalla Hospital, Uddevalla 451 80, Sweden

Department of Pulmonary medicine, Umeå University Hospital, Umeå 901 85, Sweden

Department of Pulmonary Medicine and Allergology, Uppsala University Hospital, Uppsala 751 85, Sweden

Department of Medicine, Ystad Hospital, Ystad SE-27182, Sweden

Department of Pulmonary Medicine, Örebro University Hospital, Örebro 701 85, Sweden

Additional Information

Starting date: May 2006
Last updated: June 29, 2009

Page last updated: August 20, 2015

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