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Celecoxib and Radiation Therapy in Treating Patients With Locally Advanced Non-Small Cell Lung Cancer

Information source: Radiation Therapy Oncology Group
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Lung Cancer

Intervention: celecoxib (Drug); radiation therapy (Radiation)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: Radiation Therapy Oncology Group

Official(s) and/or principal investigator(s):
Elizabeth M. Gore, MD, Study Chair, Affiliation: Medical College of Wisconsin

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.

Clinical Details

Official title: 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

Study design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Maximum Tolerated Dose (MTD) of Celecoxib Combined With Radiation Therapy (RT)

Overall Survival

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 (VEGF), basic

fibroblast growth factor (bFGF), and interleukin-8 (IL8) with survival in patients treated with this regimen.

- Correlate circulating levels of interleukin-1 (IL1), interleukin-6 (IL6), and

transforming growth factor-beta (TGFB) 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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

- International Normalized Ratio (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

Locations and Contacts

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, St. 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

Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: July 2002
Last updated: January 28, 2014

Page last updated: August 20, 2015

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