A Phase 2 interventional study of Celecoxib and Docetaxel in Lung Cancer, sponsored by Barbara Ann Karmanos Cancer Institute. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-04-29.
Sponsored by Barbara Ann Karmanos Cancer Institute · Phase 2, Interventional, and Treatment
RATIONALE: Celecoxib may slow the growth of cancer by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy and celecoxib may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of celecoxib and docetaxel in treating patients who have non-small cell lung cancer.
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive oral celecoxib twice daily (beginning on day -7 of the first course) and docetaxel IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 2 additional courses after CR. Patients who achieve stable disease (SD) or a partial response (PR) receive a minimum of 2 additional courses after SD or PR. At the discretion of the treating physician, patients then receive maintenance therapy comprising celecoxib only.
Patients who discontinue therapy for disease progression or unacceptable toxicity are followed for at least 6 months.
PROJECTED ACCRUAL: A total of 21-39 patients will be accrued for this study within 13-28 months.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 34 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Barbara Ann Karmanos Cancer Institute is the lead sponsor of 158 studies on the registry; 19 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 6 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Diagnosis of non-small cell lung cancer (NSCLC)
No symptomatic or untreated brain or leptomeningeal metastases
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Gastrointestinal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Celecoxib: On day -7 of the first cycle, patients will start, Celecoxib 400 mg po bid daily, each dose to give with meals Docetaxel: On day 1, 8, and 15 of each cycle patients will receive: Docetaxel 36mg/m2 over 60 minutes, duration of each cycle will be 28 days.
Drug: Celecoxib · Drug: Docetaxel
On day -7 of the first cycle, patients will start, Celecoxib 400 mg po bid daily, each dose to give with meals
Also known as: Celebrex, Celebra
On day 1, 8, and 15 of each cycle patients will receive: Docetaxel 36mg/m2 over 60 minutes, duration of each cycle will be 28 days.
Also known as: Taxotere®
Efficacy of combining celecoxib with docetaxel in elderly (> or = 70 yrs old) or poor performance status (PS)of 2
Blood levels of VEGF \& PGE2
Time frame: Weeks 1, 2, and 3
Response rate of Celecoxib and Docetaxel
CT Chest/Abdomen
Time frame: Every 2 cycles (or every 42 days); After therapy is completed or if the patient is only on Celecosxib, will be assessed for progression every month by clinical exam and every 3 months by radiological evaluation.
Toxicity of Celecoxib and Docetaxel
Routine bloodwork
Time frame: Weeks 1, 2, and 3 of each 28 day cycle
Expression of cyclooxygenase-2 (COX-2) in tumors
Tissue sample from initial diagnosis, parrafin embedded tissue block
Time frame: Pre-Study
Changes in plasma levels of prostaglandin E2(PGE2) & vascular endothelial growth factor (VEGF)
Collecting blood plasma
Time frame: Pre-study, Weeks 1, 2 and 5
This study is completed, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Barbara Ann Karmanos Cancer Institute