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Clinical Trial Name - Celecoxib and Radiation Therapy in Treating Patients With Locally Advanced Non-Small Cell Lung Can
| Original Study ID : CDR0000069476 |
| Secondary ID : RTOG-0213 |
| NCT ID : NCT00046839 |
| Brief Title : Celecoxib and Radiation Therapy in Treating Patients With Locally Advanced Non-Small Cell Lung Cancer |
| Official Title : A Phase I/II Trial of a COX-2 Inhibitor, Celebrex (Celecoxib), [NSC# 719627] With Limited Field Radiation for Intermediate Prognosis Patients With Locally Advanced Non-Small Cell Lung Cancer, With Analysis of Prognostic Factors |
| Brief Summary : 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. |
| Source : National Cancer Institute (NCI) |
| Detailed Description : OBJECTIVES: - Determine the maximum tolerated dose and the recommended phase II dose of concurrent celecoxib and limited-field radiotherapy in intermediate-prognosis patients with locally advanced non-small cell lung cancer. - Determine the efficacy and toxicity of this regimen in these patients. - Determine how the predictors of mortality in the general population (i.e., comorbid conditions, functional status, quality of life, and psychological status) influence prognosis, toxicity, and outcomes of therapy in patients treated with this regimen. - Correlate circulating levels of vascular endothelial growth factor, basic fibroblast growth factor, and interleukin-8 with survival in patients treated with this regimen. - Correlate circulating levels of interleukin-1, interleukin-6, and tranforming growth factor-beta with pulmonary toxicity in patients treated with this regimen. OUTLINE: This is a phase I dose-escalation study of celecoxib followed by a phase II, multicenter study. - Phase I: Patients receive oral celecoxib twice daily. Beginning on day 6, patients undergo thoracic radiotherapy 5 days a week for 3-6.5 weeks . Patients continue to receive celecoxib for up to 2 years in the absence of disease progression or unacceptable toxicity. - Phase II: If fewer than 3 of the first 6 patients experience dose-limiting toxicity, then the dose of celecoxib is escalated for all patients in the study, including those in the first cohort. 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. |
| Overall Status : Active, not recruiting |
| Start Date : July 2002 |
| Official Title : Phase 1/Phase 2 |
| Phase : Interventional |
| Study Design : Treatment |
| Verification Date : June 2005 |
| First Received Date : October 3, 2002 |
| Trial Eligibility |
| Criteria : DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed non-small cell lung cancer - Inoperable stage IIB OR - Unresectable stage IIIA or IIIB - No evidence of hematogenous metastases PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Zubrod 2 AND more than 5% weight loss over the past 3 months OR - Zubrod 0-1 AND less than 5% weight loss over the past 3 months and refuses chemotherapy or are medically unable to tolerate combined modality therapy Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Bilirubin no greater than 2 times upper limit of normal - INR no greater than 3.0 if taking warfarin Renal - Creatinine clearance at least 50 mL/min Other - No active gastrointestinal ulcers or bleeding within the past 3 months - No other malignancy within the past 3 years except nonmelanoma skin cancer - No known hypersensitivity to celecoxib - No prior allergic-type reactions to sulfonamides - No prior asthma, urticaria, or allergic-type reactions to aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior neoadjuvant chemotherapy - No concurrent chemotherapy Endocrine therapy - No concurrent corticosteroids Radiotherapy - No prior thoracic radiotherapy Surgery - No prior complete or subtotal tumor resection Other - No concurrent NSAIDs, lithium, furosemide, or angiotensin-converting enzyme inhibitors - Concurrent aspirin (325 mg/day) for cardioprotection allowed |
| Gender : Both |
| Minimum Age : 18 Years |
| Maximum Age : N/A |
| Healthy Volunteers : No |
| Facilities |
| Facility Name : Memorial Hospital Cancer Center |
| City : Colorado Springs |
| State : Colorado |
| Zip Code : 80909 |
| Country : United States |
| Facility Name : Baptist Cancer Institute - Jacksonville |
| City : Jacksonville |
| State : Florida |
| Zip Code : 32207 |
| Country : United States |
| Facility Name : University of Florida Shands Cancer Center |
| City : Gainesville |
| State : Florida |
| Zip Code : 32610 |
| Country : United States |
| Facility Name : University of Miami Sylvester Comprehensive Cancer Center |
| City : Miami |
| State : Florida |
| Zip Code : 33136 |
| Country : United States |
| Facility Name : Regional Radiation Oncology Center at Rome |
| City : Rome |
| State : Georgia |
| Zip Code : 30165 |
| Country : United States |
| Facility Name : Ingalls Cancer Care Center at Ingalls Memorial Hospital |
| City : Harvey |
| State : Illinois |
| Zip Code : 60426 |
| Country : United States |
| Facility Name : Indiana University Cancer Center |
| City : Indianapolis |
| State : Indiana |
| Zip Code : 46202 |
| Country : United States |
| Facility Name : Wendt Regional Cancer Center at Finley Hospital |
| City : Dubuque |
| State : Iowa |
| Zip Code : 52001 |
| Country : United States |
| Facility Name : Markey Cancer Center at University of Kentucky Chandler Medical Center |
| City : Lexington |
| State : Kentucky |
| Zip Code : 40536 |
| Country : United States |
| Facility Name : West Michigan Cancer Center |
| City : Kalamazoo |
| State : Michigan |
| Zip Code : 49007 |
| Country : United States |
| Facility Name : CCOP - Metro-Minnesota |
| City : Saint Louis Park |
| State : Minnesota |
| Zip Code : 55416 |
| Country : United States |
| Facility Name : Park Nicollet Clinic |
| City : St. Louis Park |
| State : Minnesota |
| Zip Code : 55416 |
| Country : United States |
| Facility Name : Virginia Piper Cancer Institute at Abbott-Northwestern Hospital |
| City : Minneapolis |
| State : Minnesota |
| Zip Code : 55403 |
| Country : United States |
| Facility Name : CCOP - Kansas City |
| City : Kansas City |
| State : Missouri |
| Zip Code : 64131 |
| Country : United States |
| Facility Name : St. John's Regional Health Center |
| City : Springfield |
| State : Missouri |
| Zip Code : 65804 |
| Country : United States |
| Facility Name : Fox Chase Virtua Health Cancer Program - Marlton |
| City : Mount Holly |
| State : New Jersey |
| Zip Code : 08060 |
| Country : United States |
| Facility Name : Monmouth Medical Center |
| City : Long Branch |
| State : New Jersey |
| Zip Code : 07740 |
| Country : United States |
| Facility Name : Albuquerque Regional Medical Center at Lovelace Sandia Health System |
| City : Albuquerque |
| State : New Mexico |
| Zip Code : 87102 |
| Country : United States |
| Facility Name : University of New Mexico Cancer Research and Treatment Center |
| City : Albuquerque |
| State : New Mexico |
| Zip Code : 87106 |
| Country : United States |
| Facility Name : Trinity Cancer Care Center |
| City : Minot |
| State : North Dakota |
| Zip Code : 58701 |
| Country : United States |
| Facility Name : Akron City Hospital at Summa Health System |
| City : Akron |
| State : Ohio |
| Zip Code : 44304 |
| Country : United States |
| Facility Name : Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford |
| City : Salem |
| State : Ohio |
| Zip Code : 44460 |
| Country : United States |
| Facility Name : Cancer Treatment Center |
| City : Wooster |
| State : Ohio |
| Zip Code : 44691 |
| Country : United States |
| Facility Name : Radiation Oncology Center |
| City : Alliance |
| State : Ohio |
| Zip Code : 44601 |
| Country : United States |
| Facility Name : Natalie Warren Bryant Cancer Center at St. Francis Hospital |
| City : Tulsa |
| State : Oklahoma |
| Zip Code : 74136 |
| Country : United States |
| Facility Name : Bryn Mawr Hospital |
| City : Bryn Mawr |
| State : Pennsylvania |
| Zip Code : 19010 |
| Country : United States |
| Facility Name : Cancer Center at Paoli Memorial Hospital |
| City : Paoli |
| State : Pennsylvania |
| Zip Code : 19301 |
| Country : United States |
| Facility Name : CCOP - MainLine Health |
| City : Wynnewood |
| State : Pennsylvania |
| Zip Code : 19096 |
| Country : United States |
| Facility Name : Fox Chase Cancer Center |
| City : Philadelphia |
| State : Pennsylvania |
| Zip Code : 19111-2497 |
| Country : United States |
| Facility Name : Lankenau Cancer Center at Lankenau Hospital |
| City : Wynnewood |
| State : Pennsylvania |
| Zip Code : 19096 |
| Country : United States |
| Facility Name : Mercy Hospital Cancer Center - Scranton |
| City : Scranton |
| State : Pennsylvania |
| Zip Code : 18501 |
| Country : United States |
| Facility Name : CCOP - Greenville |
| City : Greenville |
| State : South Carolina |
| Zip Code : 29615 |
| Country : United States |
| Facility Name : CCOP - Upstate Carolina |
| City : Spartanburg |
| State : South Carolina |
| Zip Code : 29304 |
| Country : United States |
| Facility Name : Dixie Regional Medical Center |
| City : St. George |
| State : Utah |
| Zip Code : 84770 |
| Country : United States |
| Facility Name : LDS Hospital |
| City : Salt Lake City |
| State : Utah |
| Zip Code : 84143 |
| Country : United States |
| Facility Name : Utah Valley Regional Medical Center - Provo |
| City : Provo |
| State : Utah |
| Zip Code : 84603 |
| Country : United States |
| Facility Name : North Star Lodge Cancer Center |
| City : Yakima |
| State : Washington |
| Zip Code : 98902 |
| Country : United States |
| Facility Name : St. Joseph Hospital Community Cancer Center |
| City : Bellingham |
| State : Washington |
| Zip Code : 98225 |
| Country : United States |
| Facility Name : All Saints Cancer Center at All Saints Healthcare |
| City : Racine |
| State : Wisconsin |
| Zip Code : 53405 |
| Country : United States |
| Facility Name : Community Memorial Hospital |
| City : Menomonee Falls |
| State : Wisconsin |
| Zip Code : 53051 |
| Country : United States |
| Facility Name : Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center |
| City : La Crosse |
| State : Wisconsin |
| Zip Code : 54601 |
| Country : United States |
| Facility Name : Medical College of Wisconsin Cancer Center |
| City : Milwaukee |
| State : Wisconsin |
| Zip Code : 53226 |
| Country : United States |
| Facility Name : University of Wisconsin Cancer Center at Aspirus Wausau Hospital |
| City : Wausau |
| State : Wisconsin |
| Zip Code : 54401 |
| Country : United States |
| Facility Name : Veterans Affairs Medical Center - Milwaukee (Zablocki) |
| City : Milwaukee |
| State : Wisconsin |
| Zip Code : 53295 |
| Country : United States |
| Interventions |
| Type : Drug |
| Name : celecoxib |
| Type : Radiation |
| Name : radiation therapy |
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