Radiation Therapy Plus Celecoxib, Fluorouracil, and Cisplatin in Patients With Locally Advanced Cervical Cancer

Sponsor

Radiation Therapy Oncology Group (Other)

Overall Status

Completed

CT.gov ID

NCT00023660

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Locations

2.3

Patients Per Site

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cervical Cancer	Drug: celecoxib Drug: cisplatin Drug: fluorouracil Radiation: brachytherapy Radiation: radiation therapy	Phase 1/Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

84 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase I/II Study Of COX-2 Inhibitor, CELEBREX (CELECOXIB), And Chemoradiation In Patients With Locally Advanced Cervical Cancer

Study Start Date :

Aug 1, 2001

Actual Primary Completion Date :

Jan 1, 2005

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mobile Infirmary Medical Center	Mobile	Alabama	United States	36652-2144
2	Foundation for Cancer Research and Education	Phoenix	Arizona	United States	85013
3	Mills-Peninsula Health Services	Burlingame	California	United States	94010
4	Sutter Health Western Division Cancer Research Group	Greenbrae	California	United States	94904
5	UCSF Comprehensive Cancer Center	San Francisco	California	United States	94143-0128
6	Memorial Hospital Cancer Center	Colorado Springs	Colorado	United States	80909
7	Baptist Hospital of Miami	Miami	Florida	United States	33256-2110
8	Regional Radiation Oncology Center at Rome	Rome	Georgia	United States	30165
9	Methodist Medical Center of Illinois	Peoria	Illinois	United States	61636
10	Ball Memorial Hospital Cancer Center	Muncie	Indiana	United States	47303-3499
11	West Michigan Cancer Center	Kalamazoo	Michigan	United States	49007
12	CCOP - Kansas City	Kansas City	Missouri	United States	64131
13	Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha	Omaha	Nebraska	United States	68114-4199
14	CCOP - Southern Nevada Cancer Research Foundation	Las Vegas	Nevada	United States	89106
15	Monmouth Medical Center	Long Branch	New Jersey	United States	07740-6395
16	South Jersey Regional Cancer Center	Millville	New Jersey	United States	08332
17	Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital	Mount Holly	New Jersey	United States	08060
18	Newark Beth Israel Medical Center	Newark	New Jersey	United States	07112
19	Community Medical Center	Toms River	New Jersey	United States	08755
20	State University of New York Health Science Center at Brooklyn	Brooklyn	New York	United States	11203
21	New York Methodist Hospital	Brooklyn	New York	United States	11215
22	Comprehensive Cancer Center at Wake Forest University	Winston-Salem	North Carolina	United States	27157-1065
23	Akron General Medical Center	Akron	Ohio	United States	44302
24	Akron City Hospital - Summa Health System	Akron	Ohio	United States	44304
25	Bryn Mawr Hospital	Bryn Mawr	Pennsylvania	United States	19010
26	Mercy Fitzgerald Hospital	Darby	Pennsylvania	United States	19023
27	Delaware County Memorial Hospital	Drexel Hill	Pennsylvania	United States	19026
28	Paoli Memorial Hospital	Paoli	Pennsylvania	United States	19301-1792
29	Kimmel Cancer Center at Thomas Jefferson University - Philadelphia	Philadelphia	Pennsylvania	United States	19107-5097
30	Western Pennsylvania Hospital	Pittsburgh	Pennsylvania	United States	15224
31	CCOP - MainLine Health	Wynnewood	Pennsylvania	United States	19096
32	Lankenau Cancer Center at Lankenau Hospital	Wynnewood	Pennsylvania	United States	19096
33	University of Texas - MD Anderson Cancer Center	Houston	Texas	United States	77030-4009
34	Dixie Regional Medical Center	Saint George	Utah	United States	84770
35	LDS Hospital	Salt Lake City	Utah	United States	84143
36	CCOP - Marshfield Clinic Research Foundation	Marshfield	Wisconsin	United States	54449