Celecoxib and Radiation Therapy in Treating Patients With Locally Advanced Non-Small Cell Lung Cancer
A Phase I/II Trial of a COX-2 Inhibitor, Celebrex (Celecoxib), [National Screening Committee# 719627] With Limited Field Radiation for Intermediate Prognosis Patients With Locally Advanced Non-Small Cell Lung Cancer, With Analysis of Prognostic Factors
2 other identifiers
interventional
21
1 country
44
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 lung-cancer
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2002
CompletedFirst Submitted
Initial submission to the registry
October 3, 2002
CompletedFirst Posted
Study publicly available on registry
January 27, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedResults Posted
Study results publicly available
March 17, 2014
CompletedNovember 17, 2015
November 1, 2015
9.2 years
October 3, 2002
January 28, 2014
November 14, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
Study Arms (3)
Phase I: Celecoxib 200mg BID + RT
EXPERIMENTALCOX-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
EXPERIMENTALCOX-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
EXPERIMENTALCOX-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.
Interventions
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
- Radiation Therapy Oncology Grouplead
- National Cancer Institute (NCI)collaborator
Study Sites (44)
Memorial Hospital Cancer Center
Colorado Springs, Colorado, 80909, United States
University of Florida Shands Cancer Center
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
Related Publications (1)
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.
PMID: 21550559RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
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.
Results Point of Contact
- Title
- Wendy Seiferheld
- Organization
- Radiation Therapy Oncology Group (RTOG)
Study Officials
- STUDY CHAIR
Elizabeth M. Gore, MD
Medical College of Wisconsin
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 3, 2002
First Posted
January 27, 2003
Study Start
July 1, 2002
Primary Completion
September 1, 2011
Last Updated
November 17, 2015
Results First Posted
March 17, 2014
Record last verified: 2015-11