Celecoxib and Radiation Therapy in Treating Patients With Locally Advanced Non-Small Cell Lung Cancer
This study has been completed.
Sponsor:
Radiation Therapy Oncology Group
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00046839
First received: October 3, 2002
Last updated: September 20, 2011
Last verified: June 2005
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: celecoxib Radiation: radiation therapy |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
| Study Start Date: | July 2002 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00046839
Hide Study Locations
Hide Study LocationsLocations
| United States, Colorado | |
| Memorial Hospital Cancer Center | |
| Colorado Springs, Colorado, United States, 80909 | |
| United States, Florida | |
| University of Florida Shands Cancer Center | |
| Gainesville, Florida, United States, 32610 | |
| Baptist Cancer Institute - Jacksonville | |
| Jacksonville, Florida, United States, 32207 | |
| University of Miami Sylvester Comprehensive Cancer Center | |
| Miami, Florida, United States, 33136 | |
| United States, Georgia | |
| Regional Radiation Oncology Center at Rome | |
| Rome, Georgia, United States, 30165 | |
| United States, Illinois | |
| Ingalls Cancer Care Center at Ingalls Memorial Hospital | |
| Harvey, Illinois, United States, 60426 | |
| United States, Indiana | |
| Indiana University Cancer Center | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Iowa | |
| Wendt Regional Cancer Center at Finley Hospital | |
| Dubuque, Iowa, United States, 52001 | |
| United States, Kentucky | |
| Markey Cancer Center at University of Kentucky Chandler Medical Center | |
| Lexington, Kentucky, United States, 40536 | |
| United States, Michigan | |
| West Michigan Cancer Center | |
| Kalamazoo, Michigan, United States, 49007 | |
| United States, Minnesota | |
| Virginia Piper Cancer Institute at Abbott-Northwestern Hospital | |
| Minneapolis, Minnesota, United States, 55403 | |
| CCOP - Metro-Minnesota | |
| Saint Louis Park, Minnesota, United States, 55416 | |
| Park Nicollet Clinic | |
| St. Louis Park, Minnesota, United States, 55416 | |
| United States, Missouri | |
| CCOP - Kansas City | |
| Kansas City, Missouri, United States, 64131 | |
| St. John's Regional Health Center | |
| Springfield, Missouri, United States, 65804 | |
| United States, New Jersey | |
| Monmouth Medical Center | |
| Long Branch, New Jersey, United States, 07740 | |
| Fox Chase Virtua Health Cancer Program - Marlton | |
| Mount Holly, New Jersey, United States, 08060 | |
| United States, New Mexico | |
| Albuquerque Regional Medical Center at Lovelace Sandia Health System | |
| Albuquerque, New Mexico, United States, 87102 | |
| University of New Mexico Cancer Research and Treatment Center | |
| Albuquerque, New Mexico, United States, 87106 | |
| United States, North Dakota | |
| Trinity Cancer Care Center | |
| Minot, North Dakota, United States, 58701 | |
| United States, Ohio | |
| Akron City Hospital at Summa Health System | |
| Akron, Ohio, United States, 44304 | |
| Radiation Oncology Center | |
| Alliance, Ohio, United States, 44601 | |
| Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford | |
| Salem, Ohio, United States, 44460 | |
| Cancer Treatment Center | |
| Wooster, Ohio, United States, 44691 | |
| United States, Oklahoma | |
| Natalie Warren Bryant Cancer Center at St. Francis Hospital | |
| Tulsa, Oklahoma, United States, 74136 | |
| United States, Pennsylvania | |
| Bryn Mawr Hospital | |
| Bryn Mawr, Pennsylvania, United States, 19010 | |
| Cancer Center at Paoli Memorial Hospital | |
| Paoli, Pennsylvania, United States, 19301 | |
| Fox Chase Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19111-2497 | |
| Mercy Hospital Cancer Center - Scranton | |
| Scranton, Pennsylvania, United States, 18501 | |
| CCOP - MainLine Health | |
| Wynnewood, Pennsylvania, United States, 19096 | |
| Lankenau Cancer Center at Lankenau Hospital | |
| Wynnewood, Pennsylvania, United States, 19096 | |
| United States, South Carolina | |
| CCOP - Greenville | |
| Greenville, South Carolina, United States, 29615 | |
| CCOP - Upstate Carolina | |
| Spartanburg, South Carolina, United States, 29304 | |
| United States, Utah | |
| Utah Valley Regional Medical Center - Provo | |
| Provo, Utah, United States, 84603 | |
| LDS Hospital | |
| Salt Lake City, Utah, United States, 84143 | |
| Dixie Regional Medical Center | |
| St. George, Utah, United States, 84770 | |
| United States, Washington | |
| St. Joseph Hospital Community Cancer Center | |
| Bellingham, Washington, United States, 98225 | |
| North Star Lodge Cancer Center | |
| Yakima, Washington, United States, 98902 | |
| United States, Wisconsin | |
| Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center | |
| La Crosse, Wisconsin, United States, 54601 | |
| Community Memorial Hospital | |
| Menomonee Falls, Wisconsin, United States, 53051 | |
| Medical College of Wisconsin Cancer Center | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Veterans Affairs Medical Center - Milwaukee (Zablocki) | |
| Milwaukee, Wisconsin, United States, 53295 | |
| All Saints Cancer Center at All Saints Healthcare | |
| Racine, Wisconsin, United States, 53405 | |
| University of Wisconsin Cancer Center at Aspirus Wausau Hospital | |
| Wausau, Wisconsin, United States, 54401 | |
Sponsors and Collaborators
Radiation Therapy Oncology Group
Investigators
| Study Chair: | Elizabeth M. Gore, MD | Medical College of Wisconsin |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00046839 History of Changes |
| Other Study ID Numbers: | CDR0000069476, RTOG-0213 |
| Study First Received: | October 3, 2002 |
| Last Updated: | September 20, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage II non-small cell lung cancer stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Celecoxib Cyclooxygenase 2 Inhibitors Cyclooxygenase Inhibitors |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Therapeutic Uses Central Nervous System Agents Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 16, 2013