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

Phase 1/Phase 2
18 Years
85 Years
Not Enrolling
Cervical Cancer

Thank you

Trial Information

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


- 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.

Inclusion Criteria


- Histologically confirmed squamous, adenocarcinoma, or adenosquamous carcinoma of the

- 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



- 18 to 85

Performance status:

- Zubrod 0-2

Life expectancy:

- At least 6 months


- WBC at least 3,000/mm^3

- Absolute granulocyte count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3


- Bilirubin no greater than 1.5 mg/dL

- AST or ALT no greater than 2.5 times upper limit of normal (ULN)


- Creatinine no greater than 1.5 mg/dL

- Creatinine clearance at least 50 mL/min

- Calcium no greater than 1.3 times ULN


- No severe heart disease


- 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


Biologic therapy:

- No recent prior celecoxib or other cyclo-oxygenase-2 inhibitor


- No prior systemic chemotherapy

Endocrine therapy:

- Not specified


- No prior radiotherapy to pelvis except transvaginal radiotherapy to control bleeding


- No prior surgery for cervical cancer except biopsy


- No concurrent phenytoin or lithium

- No other concurrent NSAIDs

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

David K. Gaffney, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Utah


United States: Federal Government

Study ID:




Start Date:

August 2001

Completion Date:

Related Keywords:

  • Cervical Cancer
  • 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
  • Uterine Cervical Neoplasms



University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009
State University of New York Health Science Center at Brooklyn Brooklyn, New York  11203
CCOP - Kansas City Kansas City, Missouri  64131
CCOP - Southern Nevada Cancer Research Foundation Las Vegas, Nevada  89106
West Michigan Cancer Center Kalamazoo, Michigan  49007-3731
Comprehensive Cancer Center at Wake Forest University Winston-Salem, North Carolina  27157-1082
Sutter Health Western Division Cancer Research Group Greenbrae, California  94904
Memorial Hospital Cancer Center Colorado Springs, Colorado  80909
Baptist Hospital of Miami Miami, Florida  33176-2197
Methodist Medical Center of Illinois Peoria, Illinois  61636
Newark Beth Israel Medical Center Newark, New Jersey  07112
Community Medical Center Toms River, New Jersey  08755
New York Methodist Hospital Brooklyn, New York  11215-3609
Akron General Medical Center Akron, Ohio  44302
Delaware County Memorial Hospital Drexel Hill, Pennsylvania  19026
Western Pennsylvania Hospital Pittsburgh, Pennsylvania  15224
CCOP - MainLine Health Wynnewood, Pennsylvania  19096
Dixie Regional Medical Center Saint George, Utah  84770
LDS Hospital Salt Lake City, Utah  84143
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia Philadelphia, Pennsylvania  19107
Foundation for Cancer Research and Education Phoenix, Arizona  85013
Monmouth Medical Center Long Branch, New Jersey  07740-6395
South Jersey Regional Cancer Center Millville, New Jersey  08332
UCSF Comprehensive Cancer Center San Francisco, California  94115
Mobile Infirmary Medical Center Mobile, Alabama  36640-0460
Regional Radiation Oncology Center at Rome Rome, Georgia  30165
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Mount Holly, New Jersey  08060
Mercy Fitzgerald Hospital Darby, Pennsylvania  19023
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha Omaha, Nebraska  68114-4199
CCOP - Marshfield Clinic Research Foundation Marshfield, Wisconsin  54449
Paoli Memorial Hospital Paoli, Pennsylvania  19301-1792
Bryn Mawr Hospital Bryn Mawr, Pennsylvania  19010
Lankenau Cancer Center at Lankenau Hospital Wynnewood, Pennsylvania  19096
Mills-Peninsula Health Services Burlingame, California  94010
Ball Memorial Hospital Cancer Center Muncie, Indiana  47303-3499
Akron City Hospital - Summa Health System Akron, Ohio  44304