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

Condition(s) targeted: Cervical Cancer

Intervention: celecoxib (Drug); cisplatin (Drug); fluorouracil (Drug); antiangiogenesis therapy (Procedure); chemotherapy (Procedure); radiation brachytherapy (Procedure); radiation therapy (Procedure)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: Radiation Therapy Oncology Group

Official(s) and/or principal investigator(s):
David K. Gaffney, MD, PhD, Study Chair, Affiliation: University of Utah

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.

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

Study design: Treatment

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.

Minimum age: 18 Years. Maximum age: 85 Years. Gender(s): Female.

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

Mobile Infirmary Medical Center, Mobile, Alabama 36652-2144, United States

Foundation for Cancer Research and Education, Phoenix, Arizona 85013, United States

Mills-Peninsula Health Services, Burlingame, California 94010, United States

Sutter Health Western Division Cancer Research Group, Greenbrae, California 94904, United States

UCSF Comprehensive Cancer Center, San Francisco, California 94143-0128, United States

Memorial Hospital Cancer Center, Colorado Springs, Colorado 80909, United States

Baptist Hospital of Miami, Miami, Florida 33256-2110, United States

Regional Radiation Oncology Center at Rome, Rome, Georgia 30165, United States

Methodist Medical Center of Illinois, Peoria, Illinois 61636, United States

Ball Memorial Hospital Cancer Center, Muncie, Indiana 47303-3499, United States

West Michigan Cancer Center, Kalamazoo, Michigan 49007, United States

CCOP - Kansas City, Kansas City, Missouri 64131, United States

Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha, Omaha, Nebraska 68114-4199, United States

CCOP - Southern Nevada Cancer Research Foundation, Las Vegas, Nevada 89106, United States

Community Medical Center, Toms River, New Jersey 08755, United States

Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital, Mount Holly, New Jersey 08060, United States

Monmouth Medical Center, Long Branch, New Jersey 07740-6395, United States

Newark Beth Israel Medical Center, Newark, New Jersey 07112, United States

South Jersey Regional Cancer Center, Millville, New Jersey 08332, United States

New York Methodist Hospital, Brooklyn, New York 11215, United States

State University of New York Health Science Center at Brooklyn, Brooklyn, New York 11203, United States

Comprehensive Cancer Center at Wake Forest University, Winston-Salem, North Carolina 27157-1065, United States

Akron City Hospital - Summa Health System, Akron, Ohio 44304, United States

Akron General Medical Center, Akron, Ohio 44302, United States

Bryn Mawr Hospital, Bryn Mawr, Pennsylvania 19010, United States

CCOP - MainLine Health, Wynnewood, Pennsylvania 19096, United States

Delaware County Memorial Hospital, Drexel Hill, Pennsylvania 19026, United States

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia, Philadelphia, Pennsylvania 19107-5097, United States

Lankenau Cancer Center at Lankenau Hospital, Wynnewood, Pennsylvania 19096, United States

Mercy Fitzgerald Hospital, Darby, Pennsylvania 19023, United States

Paoli Memorial Hospital, Paoli, Pennsylvania 19301-1792, United States

Western Pennsylvania Hospital, Pittsburgh, Pennsylvania 15224, United States

University of Texas - MD Anderson Cancer Center, Houston, Texas 77030-4009, United States

Dixie Regional Medical Center, Saint George, Utah 84770, United States

LDS Hospital, Salt Lake City, Utah 84143, United States

CCOP - Marshfield Clinic Research Foundation, Marshfield, Wisconsin 54449, United States

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: August 2001
Last updated: December 15, 2007