NCT00300729

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 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
319

participants targeted

Target at P25-P50 for phase_3 nonsmall-cell-lung-cancer

Timeline
Completed

Started May 2006

Geographic Reach
1 country

13 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 9, 2006

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2006

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

June 30, 2009

Status Verified

June 1, 2009

Enrollment Period

4 years

First QC Date

March 8, 2006

Last Update Submit

June 29, 2009

Conditions

Non-Small Cell Lung Cancer

Keywords

Cyclooxygenase-2 inhibitorsCelecoxibCarcinoma, non-small-cell lungAntineoplastic agentsTherapy, palliativeSurvival

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    Minimum follow-up 1 yr after randomization

Secondary Outcomes (5)

  • Quality of life

    Week 0, 3, 6, 9, 12, 20, 28, 36, 44

  • Progression-free survival

    minimum follow-up 1 yr after randomization

  • Toxicity

    Within one month after stopping study drug

  • Cardiovascular events

    Within one month after stopping study drug

  • Biological parameters (plasma VEGF, proteomics)

    Week 0, 6, 12, and 20

Study Arms (2)

Celecoxib

ACTIVE COMPARATOR

Four cycles of combination chemotherapy, usually with carboplatin + gemcitabine or carboplatin + vinorelbine, plus celecoxib 400 mg b.i.d. Treatment with celecoxib is continued after completion of chemotherapy. Maximum treatment duration is one year.

Drug: Celecoxib

Placebo

PLACEBO COMPARATOR

Chemotherapy as in arm 1 plus placebo capsules, b.i.d.

Drug: Placebo

Interventions

CelecoxibDRUG

Celecoxib 400 mg twice daily, orally, starting on the same day as palliative chemotherapy. Maximum duration of treatment is one year. Treatment should be terminated earlier in case of disease progression, unacceptable toxicity, or if the patient wants to stop treatment.

Also known as: Celebra, Onsenal
Celecoxib
PlaceboDRUG

One capsule twice daily, starting on the same day as palliative chemotherapy. Maximum duration of treatment is one year. Treatment should be terminated earlier in case of disease progression, unacceptable toxicity, or if the patient wants to stop treatment.

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Department of Pulmonary Medicine and Allergology, Sahlgrenska University Hospital

Gothenburg, 413 45, Sweden

Location

Section of Pulmonary Medicine, Ryhov County Hospital

Jönköping, 551 85, Sweden

Location

Section of Pulmonary Medicine and Allergology, County Hospital of Kalmar

Kalmar, 391 85, Sweden

Location

Department of Pulmonary Medicine, University Hospital

Linköping, 581 85, Sweden

Location

Department of Pulmonary Medicine and Allergy, Lund University Hospital

Lund, 221 85, Sweden

Location

Section of Pulmonary Medicine, Malmö University Hospital

Malmo, 205 02, Sweden

Location

Department of Pulmonary Medicine, Örebro University Hospital

Örebro, 701 85, Sweden

Location

Department of Medicine, Skövde Hospital/KSS

Skövde, 541 85, Sweden

Location

Department of Medicine, Trollhättan Hospital/NÄL

Trollhättan, 461 85, Sweden

Location

Department of Medicine, Uddevalla Hospital

Uddevalla, 451 80, Sweden

Location

Department of Pulmonary medicine, Umeå University Hospital

Umeå, 901 85, Sweden

Location

Department of Pulmonary Medicine and Allergology, Uppsala University Hospital

Uppsala, 751 85, Sweden

Location

Department of Medicine, Ystad Hospital

Ystad, SE-27182, Sweden

Location

Related Publications (1)

  • Koch A, Bergman B, Holmberg E, Sederholm C, Ek L, Kosieradzki J, Lamberg K, Thaning L, Ydreborg SO, Sorenson S; Swedish Lung Cancer Study Group. Effect of celecoxib on survival in patients with advanced non-small cell lung cancer: a double blind randomised clinical phase III trial (CYCLUS study) by the Swedish Lung Cancer Study Group. Eur J Cancer. 2011 Jul;47(10):1546-55. doi: 10.1016/j.ejca.2011.03.035. Epub 2011 May 10.

    PMID: 21565487DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Sverre Sörenson, MD, PhD

    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

    STUDY CHAIR

  • Andrea Koch, MD

    Allergy Centre, University Hospital, Linköping, Sweden, Department of Pulmonary Medicine, University Hospital, Linköping, Sweden, and Department of Medical and Health Sciences, Linköping University, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 8, 2006

First Posted

March 9, 2006

Study Start

May 1, 2006

Primary Completion

May 1, 2010

Study Completion

September 1, 2010

Last Updated

June 30, 2009

Record last verified: 2009-06

Locations

SE(13)