A Phase 1/2 interventional study of celecoxib and radiation therapy in Lung Cancer, sponsored by Radiation Therapy Oncology Group. Completed at 44 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-11-17.
Sponsored by Radiation Therapy Oncology Group · Phase 1/2, Interventional, and Treatment
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Celecoxib may stop the growth of tumor cells by stopping blood flow to the tumor and may make the tumor cells more sensitive to radiation therapy.
PURPOSE: Phase I/II trial to study the effectiveness of combining celecoxib with radiation therapy in treating patients who have locally advanced non-small cell lung cancer.
OBJECTIVES:
OUTLINE: This is a phase I dose-escalation study of celecoxib followed by a phase II, multicenter study.
Quality of life is assessed at baseline and at 3, 6, and 12 months after start of therapy.
Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 6-12 patients will be accrued for the phase I portion of this study and a total of 116 patients will be accrued for the phase II portion of this study within 25 months.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 21 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Radiation Therapy Oncology Group is the lead sponsor of 154 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
COX-2 Inhibitor: Celecoxib 200 mg b.i.d, 7 days/week begins 5 days prior to start of radiation therapy (RT). Once RT begins, Celecoxib a.m. dose 1-2 hours prior to RT. Administer for 2 years or until disease progression. Concurrent Radiation Therapy: 2 Gy daily, 30-33 fractions, 5 days/week for 6-7 weeks, for a total dose of 60-66 Gy; or 3 Gy daily, 15 fractions, 5 days/week for 3-4 weeks for a total dose of 45 Gy.
Drug: celecoxib · Radiation: radiation therapy
COX-2 Inhibitor: Celecoxib 400 mg b.i.d, 7 days/week begins 5 days prior to start of radiation therapy (RT). Once RT begins, Celecoxib a.m. dose 1-2 hours prior to RT. Administer for 2 years or until disease progression. Concurrent Radiation Therapy: 2 Gy daily, 30-33 fractions, 5 days/week for 6-7 weeks, for a total dose of 60-66 Gy; or 3 Gy daily, 15 fractions, 5 days/week for 3-4 weeks for a total dose of 45 Gy.
Drug: celecoxib · Radiation: radiation therapy
COX-2 Inhibitor: Celecoxib 400 mg b.i.d, 7 days/week begins 5 days prior to start of radiation therapy (RT). Once RT begins, Celecoxib a.m. dose 1-2 hours prior to RT. Administer for 2 years or until disease progression. Concurrent Radiation Therapy: 2 Gy daily, 30-33 fractions, 5 days/week for 6-7 weeks, for a total dose of 60-66 Gy; or 3 Gy daily, 15 fractions, 5 days/week for 3-4 weeks for a total dose of 45 Gy.
Drug: celecoxib · Radiation: radiation therapy
Also known as: COX-2 Inhibitor
Maximum Tolerated Dose (MTD) of Celecoxib Combined With Radiation Therapy (RT)
Patients were followed for at least 90 days from start of RT and carefully evaluated with respect to treatment morbidity. A dose limiting toxicity (DLT) was defined as grade 3 or 4 nonhematologic (excluding nausea, vomiting, and alopecia) and grade 4 hematologic toxicities. Six patients were to be accrued at each dose level. If no more than three of the six patients experienced a DLT then that dose level was considered acceptable and dose escalation occurred by accruing six more patients at the next dose level. Otherwise, the preceding dose level, if any, would be declared the MTD. The MTD would be used for the Phase II arm. At a given dose, the probability of halting dose escalation when the true toxicity is 50% or higher is at least 66% (power). In addition, if the true DLT rate is instead 20%, there will still be a 10% probability of halting dose escalation at a given dose level (type I error). Rating scale: 0 = not the MTD, 1 = MTD
Time frame: Start of treatment to 90 days
Overall Survival
Because only 21 patients (18 analyzable) out of 128 planned were accrued on this study, all analyzable patients were combined to report overall survival. The original study design planned for a comparison to a historical control, but due to the small number of patients, survival time is only reported, not tested.
Time frame: From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 12 months.
| Milestone | Experimental: Phase I: Celecoxib 200mg BID + RT | Experimental: Phase I/II: Celecoxib 400mg BID + RT |
|---|---|---|
| Started | 8 | 13 |
| Completed | 7 | 11 |
| Not completed | 1 | 2 |
| Withdrew: Ineligible / no protocol treatment | 0 | 2 |
| Withdrew: Withdrawal of consent | 1 | 0 |
Patients were followed for at least 90 days from start of RT and carefully evaluated with respect to treatment morbidity. A dose limiting toxicity (DLT) was defined as grade 3 or 4 nonhematologic (excluding nausea, vomiting, and alopecia) and grade 4 hematologic toxicities. Six patients were to be accrued at each dose level. If no more than three of the six patients experienced a DLT then that dose level was considered acceptable and dose escalation occurred by accruing six more patients at the next dose level. Otherwise, the preceding dose level, if any, would be declared the MTD. The MTD would be used for the Phase II arm. At a given dose, the probability of halting dose escalation when the true toxicity is 50% or higher is at least 66% (power). In addition, if the true DLT rate is instead 20%, there will still be a 10% probability of halting dose escalation at a given dose level (type I error). Rating scale: 0 = not the MTD, 1 = MTD
| units on a scale | Phase I: Celecoxib 200mg BID + RT | Phase I: Celecoxib 400mg BID + RT |
|---|---|---|
| Maximum Tolerated Dose (MTD) of Celecoxib Combined With Radiation Therapy (RT) | 0 | 1 |
Because only 21 patients (18 analyzable) out of 128 planned were accrued on this study, all analyzable patients were combined to report overall survival. The original study design planned for a comparison to a historical control, but due to the small number of patients, survival time is only reported, not tested.
| years | Experimental: Phase I/II: Celecoxib 200 or 400mg BID + RT |
|---|---|
| Overall Survival | 10.0 (6.1 to 16.7) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Experimental: Phase I: Celecoxib 200mg BID + RT | — | 1/7 (14.3%) | 7/7 (100%) |
| Experimental: Phase I/II: Celecoxib 400mg BID + RT | — | 1/11 (9.1%) | 8/11 (72.7%) |
| Event | Experimental: Phase I: Celecoxib 200mg BID + RT | Experimental: Phase I/II: Celecoxib 400mg BID + RT |
|---|---|---|
| Supraventricular arrhythmias (SVT/atrial fibrillation/flutter)Cardiac disorders | 1/7 | 0/11 |
| Infection without neutropeniaInfections and infestations | 0/7 | 1/11 |
| Event | Experimental: Phase I: Celecoxib 200mg BID + RT | Experimental: Phase I/II: Celecoxib 400mg BID + RT |
|---|---|---|
| Fatigue (lethargy, malaise, asthenia)General disorders | 4/7 | 4/11 |
| Dysphagia, esophagitis, odynophagia (painful swallowing)Gastrointestinal disorders | 3/7 | 0/11 |
| Radiation dermatitisInjury, poisoning and procedural complications | 3/7 | 3/11 |
| CreatinineInvestigations | 3/7 | 0/11 |
| Hematologic-OtherBlood and lymphatic system disorders | 2/7 | 0/11 |
| Hemoglobin (Hgb)Blood and lymphatic system disorders | 2/7 | 1/11 |
| Late RT Toxicity: LungGeneral disorders | 2/7 | 1/11 |
| SGPT (ALT)Investigations | 2/7 | 0/11 |
| HyperkalemiaMetabolism and nutrition disorders | 2/7 | 0/11 |
| PruritusSkin and subcutaneous tissue disorders | 2/7 | 0/11 |
Eligible patients who started protocol treatment.
| Age, Continuous(years) | Experimental: Phase I: Celecoxib 200mg BID + RT | Experimental: Phase I/II: Celecoxib 400mg BID + RT | Total |
|---|---|---|---|
| Median | 73 (65 to 88) | 71 (47 to 82) | 72 (47 to 88) |
| Sex: Female, Male(Participants) | Experimental: Phase I: Celecoxib 200mg BID + RT | Experimental: Phase I/II: Celecoxib 400mg BID + RT | Total |
|---|---|---|---|
| Female | 6 | 8 | 14 |
| Male | 1 | 3 | 4 |
This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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Radiation Therapy Oncology Group