|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||
| Sponsors and Collaborators: |
University Hospital, Linkoeping Swedish Lung Cancer Study Group (SLCSG) Pfizer |
|---|---|
| Information provided by: | University Hospital, Linkoeping |
| ClinicalTrials.gov Identifier: | NCT00300729 |
Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Small Cell Lung Cancer |
Drug: Celecoxib |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Cox-2-Inhibitor and Chemotherapy in Non-Small Cell Lung Cancer. A Prospective Randomized Double-Blind Study |
| Estimated Enrollment: | 350 |
| Study Start Date: | May 2006 |
| Estimated Study Completion Date: | May 2010 |
| Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: 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
400 mg capsule twice daily, starting on the first day of cancer chemotherapy.
|
|
2: Placebo Comparator
Chemotherapy as in arm 1 plus placebo capsules, b.i.d.
|
Drug: Celecoxib
400 mg capsule twice daily, starting on the first day of cancer chemotherapy.
|
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%), 760 patients will be required.
The study was opened for randomization on May 31, 2006. The time for randomization of patients is expected to be 3 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion criteria:
Contacts and Locations| Contact: Izabella Sandberg | +46 13 222000 | izabella.sandberg@lio.se |
| Sweden | |
| Department of Pulmonary Medicine and Allergology, Sahlgrenska University Hospital | Recruiting |
| Gothenburg, Sweden, 413 45 | |
| Principal Investigator: Bengt Bergman, MD, PhD | |
| Section of Pulmonary Medicine, Ryhov County Hospital | Recruiting |
| Jönköping, Sweden, 551 85 | |
| Principal Investigator: Sven-Olof Ydreborg, MD | |
| Section of Pulmonary Medicine and Allergology, County Hospital of Kalmar | Recruiting |
| Kalmar, Sweden, 391 85 | |
| Principal Investigator: Åsa Werin, MD | |
| Section of Pulmonary Medicine, Malmö University Hospital | Recruiting |
| Malmö, Sweden, 205 02 | |
| Principal Investigator: Jaroslaw Kosieradzski, MD | |
| Department of Medicine, Skövde Hospital/KSS | Recruiting |
| Skövde, Sweden, 541 85 | |
| Principal Investigator: Tryggve Månsson, MD | |
| Department of Medicine, Trollhättan Hospital/NÄL | Recruiting |
| Trollhättan, Sweden, 461 85 | |
| Principal Investigator: Bo Pedersen, MD | |
| Department of Medicine, Ystad Hospital | Recruiting |
| Ystad, Sweden, SE-27182 | |
| Contact: Kerstin Andersson, MD | |
| Principal Investigator: Kerstin Andersson, MD | |
| Department of Pulmonary medicine, Umeå University Hospital | Recruiting |
| Umeå, Sweden, 901 85 | |
| Principal Investigator: Rune Lundgren, MD, PhD | |
| Department of Pulmonary Medicine and Allergology, Uppsala University Hospital | Recruiting |
| Uppsala, Sweden, 751 85 | |
| Principal Investigator: Kristina Lamberg, MD | |
| Department of Pulmonary Medicine, Örebro University Hospital | Recruiting |
| Örebro, Sweden, 701 85 | |
| Principal Investigator: Lars Thaning, MD | |
| Department of Pulmonary Medicine and Allergy, Lund University Hospital | Recruiting |
| Lund, Sweden, 221 85 | |
| Principal Investigator: Lars Ek, MD | |
| Department of Medicine, Uddevalla Hospital | Recruiting |
| Uddevalla, Sweden, 451 80 | |
| Principal Investigator: Ulf Hero, MD | |
| Study Chair: | Sverre Sörenson, MD, PhD | Department of Medicine, Ryhov County Hospital, Jönköping, Sweden and University of Linköping, Linköping, Sweden |
| Principal Investigator: | Andrea Koch, MD | Department of Pulmonary Medicine, University Hospital, Linköping, Sweden |
More Information
| Responsible Party: | Swedish Lung Cancer Study Group ( Sverre Sörenson, MD, PhD ) |
| Study ID Numbers: | SLCSG0501 |
| Study First Received: | March 8, 2006 |
| Last Updated: | May 22, 2008 |
| ClinicalTrials.gov Identifier: | NCT00300729 |
| Health Authority: | Sweden: Medical Products Agency |
|
Cyclooxygenase-2 inhibitors Celecoxib Carcinoma, non-small-cell lung |
Antineoplastic agents Therapy, palliative Survival |
|
Thoracic Neoplasms Non-small cell lung cancer Celecoxib Respiratory Tract Diseases Lung Neoplasms |
Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
|
Anti-Inflammatory Agents Respiratory Tract Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Cyclooxygenase Inhibitors Enzyme Inhibitors Pharmacologic Actions Neoplasms |
Neoplasms by Site Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |
