Back to resultsRadiation Therapy Plus Celecoxib, Fluorouracil, and Cisplatin in Patients With Locally Advanced Cervical Cancer
Primary Purpose
Cervical Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
celecoxib
cisplatin
fluorouracil
brachytherapy
radiation therapy
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Cancer focused on measuring stage III cervical cancer, stage IB cervical cancer, stage IIB cervical cancer, stage IIA cervical cancer, stage IVA cervical cancer, cervical squamous cell carcinoma, cervical adenocarcinoma, cervical adenosquamous cell carcinoma
Eligibility Criteria
DISEASE CHARACTERISTICS: 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
Sites / Locations
- Mobile Infirmary Medical Center
- Foundation for Cancer Research and Education
- Mills-Peninsula Health Services
- Sutter Health Western Division Cancer Research Group
- UCSF Comprehensive Cancer Center
- Memorial Hospital Cancer Center
- Baptist Hospital of Miami
- Regional Radiation Oncology Center at Rome
- Methodist Medical Center of Illinois
- Ball Memorial Hospital Cancer Center
- West Michigan Cancer Center
- CCOP - Kansas City
- Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha
- CCOP - Southern Nevada Cancer Research Foundation
- Monmouth Medical Center
- South Jersey Regional Cancer Center
- Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital
- Newark Beth Israel Medical Center
- Community Medical Center
- State University of New York Health Science Center at Brooklyn
- New York Methodist Hospital
- Comprehensive Cancer Center at Wake Forest University
- Akron General Medical Center
- Akron City Hospital - Summa Health System
- Bryn Mawr Hospital
- Mercy Fitzgerald Hospital
- Delaware County Memorial Hospital
- Paoli Memorial Hospital
- Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
- Western Pennsylvania Hospital
- CCOP - MainLine Health
- Lankenau Cancer Center at Lankenau Hospital
- University of Texas - MD Anderson Cancer Center
- Dixie Regional Medical Center
- LDS Hospital
- CCOP - Marshfield Clinic Research Foundation
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00023660
First Posted
September 13, 2001
Last Updated
November 18, 2013
Sponsor
Radiation Therapy Oncology Group
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00023660
Brief Title
Radiation Therapy Plus Celecoxib, Fluorouracil, and Cisplatin in Patients With Locally Advanced Cervical Cancer
Official Title
A Phase I/II Study Of COX-2 Inhibitor, CELEBREX (CELECOXIB), And Chemoradiation In Patients With Locally Advanced Cervical Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
August 2001 (undefined)
Primary Completion Date
January 2005 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radiation Therapy Oncology Group
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving radiation therapy in different ways and combining it with chemotherapy may kill more tumor cells. Celecoxib may slow the growth of cervical cancer by stopping blood flow to the tumor.
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
OBJECTIVES:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
stage III cervical cancer, stage IB cervical cancer, stage IIB cervical cancer, stage IIA cervical cancer, stage IVA cervical cancer, cervical squamous cell carcinoma, cervical adenocarcinoma, cervical adenosquamous cell carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
celecoxib
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
fluorouracil
Intervention Type
Radiation
Intervention Name(s)
brachytherapy
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David K. Gaffney, MD, PhD
Organizational Affiliation
University of Utah
Official's Role
Study Chair
Facility Information:
Facility Name
Mobile Infirmary Medical Center
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36652-2144
Country
United States
Facility Name
Foundation for Cancer Research and Education
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Mills-Peninsula Health Services
City
Burlingame
State/Province
California
ZIP/Postal Code
94010
Country
United States
Facility Name
Sutter Health Western Division Cancer Research Group
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
UCSF Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143-0128
Country
United States
Facility Name
Memorial Hospital Cancer Center
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
Baptist Hospital of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33256-2110
Country
United States
Facility Name
Regional Radiation Oncology Center at Rome
City
Rome
State/Province
Georgia
ZIP/Postal Code
30165
Country
United States
Facility Name
Methodist Medical Center of Illinois
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61636
Country
United States
Facility Name
Ball Memorial Hospital Cancer Center
City
Muncie
State/Province
Indiana
ZIP/Postal Code
47303-3499
Country
United States
Facility Name
West Michigan Cancer Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Facility Name
CCOP - Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114-4199
Country
United States
Facility Name
CCOP - Southern Nevada Cancer Research Foundation
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Monmouth Medical Center
City
Long Branch
State/Province
New Jersey
ZIP/Postal Code
07740-6395
Country
United States
Facility Name
South Jersey Regional Cancer Center
City
Millville
State/Province
New Jersey
ZIP/Postal Code
08332
Country
United States
Facility Name
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital
City
Mount Holly
State/Province
New Jersey
ZIP/Postal Code
08060
Country
United States
Facility Name
Newark Beth Israel Medical Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07112
Country
United States
Facility Name
Community Medical Center
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
State University of New York Health Science Center at Brooklyn
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
New York Methodist Hospital
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11215
Country
United States
Facility Name
Comprehensive Cancer Center at Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1065
Country
United States
Facility Name
Akron General Medical Center
City
Akron
State/Province
Ohio
ZIP/Postal Code
44302
Country
United States
Facility Name
Akron City Hospital - Summa Health System
City
Akron
State/Province
Ohio
ZIP/Postal Code
44304
Country
United States
Facility Name
Bryn Mawr Hospital
City
Bryn Mawr
State/Province
Pennsylvania
ZIP/Postal Code
19010
Country
United States
Facility Name
Mercy Fitzgerald Hospital
City
Darby
State/Province
Pennsylvania
ZIP/Postal Code
19023
Country
United States
Facility Name
Delaware County Memorial Hospital
City
Drexel Hill
State/Province
Pennsylvania
ZIP/Postal Code
19026
Country
United States
Facility Name
Paoli Memorial Hospital
City
Paoli
State/Province
Pennsylvania
ZIP/Postal Code
19301-1792
Country
United States
Facility Name
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107-5097
Country
United States
Facility Name
Western Pennsylvania Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
CCOP - MainLine Health
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
Lankenau Cancer Center at Lankenau Hospital
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
University of Texas - MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
Dixie Regional Medical Center
City
Saint George
State/Province
Utah
ZIP/Postal Code
84770
Country
United States
Facility Name
LDS Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84143
Country
United States
Facility Name
CCOP - Marshfield Clinic Research Foundation
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22193645
Citation
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.
Results Reference
background
PubMed Identifier
19509178
Citation
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.
Results Reference
result
PubMed Identifier
18299147
Citation
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.
Results Reference
result
PubMed Identifier
17084549
Citation
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.
Results Reference
result
PubMed Identifier
17482376
Citation
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.
Results Reference
result
PubMed Identifier
15863167
Citation
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.
Results Reference
result
Learn more about this trial
Radiation Therapy Plus Celecoxib, Fluorouracil, and Cisplatin in Patients With Locally Advanced Cervical Cancer
We'll reach out to this number within 24 hrs