Radiation Therapy Plus Celecoxib, Fluorouracil, and Cisplatin in Patients With Locally Advanced Cervical Cancer
NCT ID: NCT00023660
Last Updated: 2013-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
84 participants
INTERVENTIONAL
2001-08-31
Brief Summary
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PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy plus celecoxib, fluorouracil, and cisplatin in treating patients who have locally advanced cervical cancer.
Detailed Description
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* Determine treatment-related toxicity rates in patients with locally advanced cervical cancer treated with external beam radiotherapy and brachytherapy concurrently with celecoxib, fluorouracil, and cisplatin.
* Determine whether this regimen increases locoregional control rates, distant control, disease-free survival, and overall survival in these patients.
* Determine whether first-failure patterns in patients treated with this regimen are changed compared to historical controls.
OUTLINE: This is a multicenter study.
Patients undergo external beam pelvic radiotherapy once daily five days a weeks for 5 weeks beginning on day 1. Within 8 weeks, patients undergo low-dose or high-dose brachytherapy. Patients also receive concurrent chemotherapy comprising fluorouracil IV continuously over days 2-5, 23-26, and 44-47 and cisplatin IV over 4 hours on days 1, 22, and 43. Oral celecoxib is administered twice daily beginning on day 1 and continuing for 12 months.
Patients are followed every 3 months for 2 years, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 83 patients will be accrued for this study within 1.5 years.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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celecoxib
cisplatin
fluorouracil
brachytherapy
radiation therapy
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed squamous, adenocarcinoma, or adenosquamous carcinoma of the cervix
* Stage IIB-IVA OR
* Stage IB-IIA with pelvic node metastases and/or tumor size at least 5 cm
* No small cell, carcinoid, glassy cell, clear cell, or adenoid cystic disease
* No metastatic disease outside of pelvis
* No para-aortic disease
PATIENT CHARACTERISTICS:
Age:
* 18 to 85
Performance status:
* Zubrod 0-2
Life expectancy:
* At least 6 months
Hematopoietic:
* WBC at least 3,000/mm\^3
* Absolute granulocyte count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin no greater than 1.5 mg/dL
* AST or ALT no greater than 2.5 times upper limit of normal (ULN)
Renal:
* Creatinine no greater than 1.5 mg/dL
* Creatinine clearance at least 50 mL/min
* Calcium no greater than 1.3 times ULN
Cardiovascular:
* No severe heart disease
Other:
* Not pregnant or nursing
* Negative pregnancy test
* HIV negative
* No prior allergy to sulfonamides or non-steroidal anti-inflammatory drugs (NSAIDs)
* No prior hypersensitivity to celecoxib or any component of its formulation
* No medical or psychiatric illness that would preclude study
* No active gastrointestinal (GI) ulcer, GI bleeding, or inflammatory bowel disease
* No other prior malignancy within the past 5 years except cutaneous basal cell skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No recent prior celecoxib or other cyclo-oxygenase-2 inhibitor
Chemotherapy:
* No prior systemic chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* No prior radiotherapy to pelvis except transvaginal radiotherapy to control bleeding
Surgery:
* No prior surgery for cervical cancer except biopsy
Other:
* No concurrent phenytoin or lithium
* No other concurrent NSAIDs
18 Years
85 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Radiation Therapy Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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David K. Gaffney, MD, PhD
Role: STUDY_CHAIR
University of Utah
Locations
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Mobile Infirmary Medical Center
Mobile, Alabama, United States
Foundation for Cancer Research and Education
Phoenix, Arizona, United States
Mills-Peninsula Health Services
Burlingame, California, United States
Sutter Health Western Division Cancer Research Group
Greenbrae, California, United States
UCSF Comprehensive Cancer Center
San Francisco, California, United States
Memorial Hospital Cancer Center
Colorado Springs, Colorado, United States
Baptist Hospital of Miami
Miami, Florida, United States
Regional Radiation Oncology Center at Rome
Rome, Georgia, United States
Methodist Medical Center of Illinois
Peoria, Illinois, United States
Ball Memorial Hospital Cancer Center
Muncie, Indiana, United States
West Michigan Cancer Center
Kalamazoo, Michigan, United States
CCOP - Kansas City
Kansas City, Missouri, United States
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha
Omaha, Nebraska, United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States
Monmouth Medical Center
Long Branch, New Jersey, United States
South Jersey Regional Cancer Center
Millville, New Jersey, United States
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital
Mount Holly, New Jersey, United States
Newark Beth Israel Medical Center
Newark, New Jersey, United States
Community Medical Center
Toms River, New Jersey, United States
State University of New York Health Science Center at Brooklyn
Brooklyn, New York, United States
New York Methodist Hospital
Brooklyn, New York, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States
Akron General Medical Center
Akron, Ohio, United States
Akron City Hospital - Summa Health System
Akron, Ohio, United States
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States
Mercy Fitzgerald Hospital
Darby, Pennsylvania, United States
Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, United States
Paoli Memorial Hospital
Paoli, Pennsylvania, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States
CCOP - MainLine Health
Wynnewood, Pennsylvania, United States
Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
LDS Hospital
Salt Lake City, Utah, United States
Dixie Regional Medical Center
St. George, Utah, United States
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, United States
Countries
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References
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Viswanathan AN, Moughan J, Small W Jr, Levenback C, Iyer R, Hymes S, Dicker AP, Miller B, Erickson B, Gaffney DK. The quality of cervical cancer brachytherapy implantation and the impact on local recurrence and disease-free survival in radiation therapy oncology group prospective trials 0116 and 0128. Int J Gynecol Cancer. 2012 Jan;22(1):123-31. doi: 10.1097/IGC.0b013e31823ae3c9.
Weidhaas JB, Li SX, Winter K, Ryu J, Jhingran A, Miller B, Dicker AP, Gaffney D. Changes in gene expression predicting local control in cervical cancer: results from Radiation Therapy Oncology Group 0128. Clin Cancer Res. 2009 Jun 15;15(12):4199-206. doi: 10.1158/1078-0432.CCR-08-2257. Epub 2009 Jun 9.
Zempolich K, Fuhrman C, Milash B, Flinner R, Greven K, Ryu J, Forbes A, Kerlin K, Nichols RC, Gaffney DK. Changes in gene expression induced by chemoradiation in advanced cervical carcinoma: a microarray study of RTOG C-0128. Gynecol Oncol. 2008 May;109(2):275-9. doi: 10.1016/j.ygyno.2008.01.027. Epub 2008 Mar 4.
Gaffney DK, Winter K, Dicker AP, Miller B, Eifel PJ, Ryu J, Avizonis V, Fromm M, Greven K. A Phase II study of acute toxicity for Celebrex (celecoxib) and chemoradiation in patients with locally advanced cervical cancer: primary endpoint analysis of RTOG 0128. Int J Radiat Oncol Biol Phys. 2007 Jan 1;67(1):104-9. doi: 10.1016/j.ijrobp.2006.08.002. Epub 2006 Nov 2.
Gaffney DK, Winter K, Dicker AP, Miller B, Eifel PJ, Ryu J, Avizonis V, Fromm M, Small W, Greven K. Efficacy and patterns of failure for locally advanced cancer of the cervix treated with celebrex (celecoxib) and chemoradiotherapy in RTOG 0128. Int J Radiat Oncol Biol Phys. 2007 Sep 1;69(1):111-7. doi: 10.1016/j.ijrobp.2007.02.050. Epub 2007 May 4.
Gaffney DK, Winter K, Fuhrman C, Flinner R, Greven K, Ryu J, Forbes A, Kerlin K, Nichols RC, Zempolich K. Feasibility of RNA collection for micro-array gene expression analysis in the treatment of cervical carcinoma: a scientific correlate of RTOG C-0128. Gynecol Oncol. 2005 May;97(2):607-11. doi: 10.1016/j.ygyno.2005.01.014.
Other Identifiers
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CDR0000068849
Identifier Type: -
Identifier Source: secondary_id
RTOG-C-0128
Identifier Type: -
Identifier Source: org_study_id