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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
Female
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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

David K. Gaffney, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Utah

Authority:

United States: Federal Government

Study ID:

CDR0000068849

NCT ID:

NCT00023660

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

Name

Location

University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
State University of New York Health Science Center at BrooklynBrooklyn, New York  11203
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Sutter Health Western Division Cancer Research GroupGreenbrae, California  94904
Memorial Hospital Cancer CenterColorado Springs, Colorado  80909
Baptist Hospital of MiamiMiami, Florida  33176-2197
Methodist Medical Center of IllinoisPeoria, Illinois  61636
Newark Beth Israel Medical CenterNewark, New Jersey  07112
Community Medical CenterToms River, New Jersey  08755
New York Methodist HospitalBrooklyn, New York  11215-3609
Akron General Medical CenterAkron, Ohio  44302
Delaware County Memorial HospitalDrexel Hill, Pennsylvania  19026
Western Pennsylvania HospitalPittsburgh, Pennsylvania  15224
CCOP - MainLine HealthWynnewood, Pennsylvania  19096
Dixie Regional Medical CenterSaint George, Utah  84770
LDS HospitalSalt Lake City, Utah  84143
Kimmel Cancer Center at Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
Foundation for Cancer Research and EducationPhoenix, Arizona  85013
Monmouth Medical CenterLong Branch, New Jersey  07740-6395
South Jersey Regional Cancer CenterMillville, New Jersey  08332
UCSF Comprehensive Cancer CenterSan Francisco, California  94115
Mobile Infirmary Medical CenterMobile, Alabama  36640-0460
Regional Radiation Oncology Center at RomeRome, Georgia  30165
Fox Chase Virtua Health Cancer Program at Virtua Memorial HospitalMount Holly, New Jersey  08060
Mercy Fitzgerald HospitalDarby, Pennsylvania  19023
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - OmahaOmaha, Nebraska  68114-4199
CCOP - Marshfield Clinic Research FoundationMarshfield, Wisconsin  54449
Paoli Memorial HospitalPaoli, Pennsylvania  19301-1792
Bryn Mawr HospitalBryn Mawr, Pennsylvania  19010
Lankenau Cancer Center at Lankenau HospitalWynnewood, Pennsylvania  19096
Mills-Peninsula Health ServicesBurlingame, California  94010
Ball Memorial Hospital Cancer CenterMuncie, Indiana  47303-3499
Akron City Hospital - Summa Health SystemAkron, Ohio  44304