Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000069476 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase I: Celecoxib 200mg BID + RT | Experimental | 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. |
|
| Phase I: Celecoxib 400mg BID + RT | Experimental | 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. |
|
| Phase II: Celecoxib 400mg BID + RT | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| celecoxib | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 12 months. |
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Elizabeth M. Gore, MD | Medical College of Wisconsin | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Hospital Cancer Center | Colorado Springs | Colorado | 80909 | United States | ||
| University of Florida Shands Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21550559 | Result | Gore E, Bae K, Langer C, Extermann M, Movsas B, Okunieff P, Videtic G, Choy H. Phase I/II trial of a COX-2 inhibitor with limited field radiation for intermediate prognosis patients who have locally advanced non-small-cell lung cancer: radiation therapy oncology group 0213. Clin Lung Cancer. 2011 Mar;12(2):125-30. doi: 10.1016/j.cllc.2011.03.007. Epub 2011 Apr 11. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Experimental: Phase I: Celecoxib 200mg BID + RT | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| radiation therapy | Radiation |
|
| Gainesville |
| Florida |
| 32610 |
| United States |
| Baptist Cancer Institute - Jacksonville | Jacksonville | Florida | 32207 | United States |
| University of Miami Sylvester Comprehensive Cancer Center | Miami | Florida | 33136 | United States |
| Regional Radiation Oncology Center at Rome | Rome | Georgia | 30165 | United States |
| Ingalls Cancer Care Center at Ingalls Memorial Hospital | Harvey | Illinois | 60426 | United States |
| Indiana University Cancer Center | Indianapolis | Indiana | 46202 | United States |
| Wendt Regional Cancer Center at Finley Hospital | Dubuque | Iowa | 52001 | United States |
| Markey Cancer Center at University of Kentucky Chandler Medical Center | Lexington | Kentucky | 40536 | United States |
| West Michigan Cancer Center | Kalamazoo | Michigan | 49007 | United States |
| Virginia Piper Cancer Institute at Abbott-Northwestern Hospital | Minneapolis | Minnesota | 55403 | United States |
| CCOP - Metro-Minnesota | Saint Louis Park | Minnesota | 55416 | United States |
| Park Nicollet Clinic | Saint Louis Park | Minnesota | 55416 | United States |
| CCOP - Kansas City | Kansas City | Missouri | 64131 | United States |
| St. John's Regional Health Center | Springfield | Missouri | 65804 | United States |
| Monmouth Medical Center | Long Branch | New Jersey | 07740 | United States |
| Fox Chase Virtua Health Cancer Program - Marlton | Mount Holly | New Jersey | 08060 | United States |
| Albuquerque Regional Medical Center at Lovelace Sandia Health System | Albuquerque | New Mexico | 87102 | United States |
| University of New Mexico Cancer Research and Treatment Center | Albuquerque | New Mexico | 87106 | United States |
| Trinity Cancer Care Center | Minot | North Dakota | 58701 | United States |
| Akron City Hospital at Summa Health System | Akron | Ohio | 44304 | United States |
| Radiation Oncology Center | Alliance | Ohio | 44601 | United States |
| Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford | Salem | Ohio | 44460 | United States |
| Cancer Treatment Center | Wooster | Ohio | 44691 | United States |
| Natalie Warren Bryant Cancer Center at St. Francis Hospital | Tulsa | Oklahoma | 74136 | United States |
| Bryn Mawr Hospital | Bryn Mawr | Pennsylvania | 19010 | United States |
| Cancer Center at Paoli Memorial Hospital | Paoli | Pennsylvania | 19301 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111-2497 | United States |
| Mercy Hospital Cancer Center - Scranton | Scranton | Pennsylvania | 18501 | United States |
| CCOP - MainLine Health | Wynnewood | Pennsylvania | 19096 | United States |
| Lankenau Cancer Center at Lankenau Hospital | Wynnewood | Pennsylvania | 19096 | United States |
| CCOP - Greenville | Greenville | South Carolina | 29615 | United States |
| CCOP - Upstate Carolina | Spartanburg | South Carolina | 29304 | United States |
| Utah Valley Regional Medical Center - Provo | Provo | Utah | 84603 | United States |
| LDS Hospital | Salt Lake City | Utah | 84143 | United States |
| Dixie Regional Medical Center | St. George | Utah | 84770 | United States |
| St. Joseph Hospital Community Cancer Center | Bellingham | Washington | 98225 | United States |
| North Star Lodge Cancer Center | Yakima | Washington | 98902 | United States |
| Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center | La Crosse | Wisconsin | 54601 | United States |
| Community Memorial Hospital | Menomonee Falls | Wisconsin | 53051 | United States |
| Medical College of Wisconsin Cancer Center | Milwaukee | Wisconsin | 53226 | United States |
| Veterans Affairs Medical Center - Milwaukee (Zablocki) | Milwaukee | Wisconsin | 53295 | United States |
| All Saints Cancer Center at All Saints Healthcare | Racine | Wisconsin | 53405 | United States |
| University of Wisconsin Cancer Center at Aspirus Wausau Hospital | Wausau | Wisconsin | 54401 | United States |
| FG001 | Experimental: Phase I/II: Celecoxib 400mg BID + RT | 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Eligible patients who started protocol treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Experimental: Phase I: Celecoxib 200mg BID + RT | 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. |
| BG001 | Experimental: Phase I/II: Celecoxib 400mg BID + RT | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | The first six eligible patients who started protocol treatment at each dose level. | Posted | Number | units on a scale | Start of treatment to 90 days |
|
|
| |||||||||||||||||||||||||||||
| Primary | 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. | Eligible patients who started protocol treatment. | Posted | Median | 95% Confidence Interval | years | From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 12 months. |
|
|
Not provided
Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental: Phase I: Celecoxib 200mg BID + RT | 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. | 1 | 7 | 7 | 7 | ||
| EG001 | Experimental: Phase I/II: Celecoxib 400mg BID + RT | 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. | 1 | 11 | 8 | 11 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Supraventricular arrhythmias (SVT/atrial fibrillation/flutter) | Cardiac disorders | CTC 2.0 | Non-systematic Assessment |
| |
| Infection without neutropenia | Infections and infestations | CTC 2.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematologic-Other | Blood and lymphatic system disorders | CTC 2.0 | Non-systematic Assessment |
| |
| Hemoglobin (Hgb) | Blood and lymphatic system disorders | CTC 2.0 | Non-systematic Assessment |
| |
| Dyspepsia/heartburn | Gastrointestinal disorders | CTC 2.0 | Non-systematic Assessment |
| |
| Dysphagia, esophagitis, odynophagia (painful swallowing) | Gastrointestinal disorders | CTC 2.0 | Non-systematic Assessment |
| |
| Dysphagia-esophageal related to radiation | Gastrointestinal disorders | CTC 2.0 | Non-systematic Assessment |
| |
| Dysphagia-pharyngeal related to radiation | Gastrointestinal disorders | CTC 2.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTC 2.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTC 2.0 | Non-systematic Assessment |
| |
| Edema | General disorders | CTC 2.0 | Non-systematic Assessment |
| |
| Fatigue (lethargy, malaise, asthenia) | General disorders | CTC 2.0 | Non-systematic Assessment |
| |
| Late RT Toxicity: Lung | General disorders | CTC 2.0 | Systematic Assessment |
| |
| Late RT Toxicity: Other | General disorders | CTC 2.0 | Systematic Assessment |
| |
| Late RT Toxicity: Skin (within the irradiated field) | General disorders | CTC 2.0 | Systematic Assessment |
| |
| Radiation dermatitis | Injury, poisoning and procedural complications | CTC 2.0 | Non-systematic Assessment |
| |
| Creatinine | Investigations | CTC 2.0 | Non-systematic Assessment |
| |
| Leukocytes (total WBC) | Investigations | CTC 2.0 | Non-systematic Assessment |
| |
| Lymphopenia | Investigations | CTC 2.0 | Non-systematic Assessment |
| |
| Metabolic-Other | Investigations | CTC 2.0 | Non-systematic Assessment |
| |
| Neutrophils/granulocytes (ANC/AGC) | Investigations | CTC 2.0 | Non-systematic Assessment |
| |
| SGPT (ALT) | Investigations | CTC 2.0 | Non-systematic Assessment |
| |
| Weight loss | Investigations | CTC 2.0 | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTC 2.0 | Non-systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTC 2.0 | Non-systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | CTC 2.0 | Non-systematic Assessment |
| |
| Hypernatremia | Metabolism and nutrition disorders | CTC 2.0 | Non-systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTC 2.0 | Non-systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition disorders | CTC 2.0 | Non-systematic Assessment |
| |
| Arthralgia (joint pain) | Musculoskeletal and connective tissue disorders | CTC 2.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | CTC 2.0 | Non-systematic Assessment |
| |
| Neuropathy motor | Nervous system disorders | CTC 2.0 | Non-systematic Assessment |
| |
| Neuropathy-sensory | Nervous system disorders | CTC 2.0 | Non-systematic Assessment |
| |
| Confusion | Psychiatric disorders | CTC 2.0 | Non-systematic Assessment |
| |
| Renal/GU-Other | Renal and urinary disorders | CTC 2.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTC 2.0 | Non-systematic Assessment |
| |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | CTC 2.0 | Non-systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | CTC 2.0 | Non-systematic Assessment |
| |
| Pigmentation changes (e.g., vitiligo) | Skin and subcutaneous tissue disorders | CTC 2.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTC 2.0 | Non-systematic Assessment |
|
This study stopped accrual early with 21 subjects accrued out of 128 planned, therefore only the phase I and phase II primary outcomes were reported.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wendy Seiferheld | Radiation Therapy Oncology Group (RTOG) | wseiferheld@acr.org |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068579 | Celecoxib |
| D052246 | Cyclooxygenase 2 Inhibitors |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D016861 | Cyclooxygenase Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000894 | Anti-Inflammatory Agents, Non-Steroidal |
| D018712 | Analgesics, Non-Narcotic |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D045505 | Physiological Effects of Drugs |
| D000893 | Anti-Inflammatory Agents |
| D045506 | Therapeutic Uses |
| D018501 | Antirheumatic Agents |
| D013812 | Therapeutics |
Not provided
Not provided
| Male |
|
|