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Radiation Therapy Plus Celecoxib, Fluorouracil, and Cisplatin in Patients With Locally Advanced Cervical Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Radiation Therapy Plus Celecoxib, Fluorouracil, and Cisplatin in Patients With Locally Advanced Cervical Cancer conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Radiation Therapy Plus Celecoxib, Fluorouracil, and Cisplatin in Patients With Locally Advanced Cervical Cancer Clinical research trials and Radiation Therapy Plus Celecoxib, Fluorouracil, and Cisplatin in Patients With Locally Advanced Cervical Cancer health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Radiation Therapy Plus Celecoxib, Fluorouracil, and Cisplatin in Patients With Locally Advanced Cervical Cancer. Radiation Therapy Plus Celecoxib, Fluorouracil, and Cisplatin in Patients With Locally Advanced Cervical Cancer Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Radiation Therapy Plus Celecoxib, Fluorouracil, and Cisplatin in Patients With Locally Advanced Cervical Cancer clinical trial. Participants oftentimes recieve the most expert healthcare available for their Radiation Therapy Plus Celecoxib, Fluorouracil, and Cisplatin in Patients With Locally Advanced Cervical Cancer condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "R" Clinical Trials Conditions > Radiation Therapy Plus Celecoxib, Fluorouracil, and Cisplatin in Patients With Locally Advanced Cervical Cancer  Radiation Therapy Plus Celecoxib, Fluorouracil, and Cisplatin in Patients With Locally Advanced Cervical Cancer
Radiation Therapy Plus Celecoxib, Fluorouracil, and Cisplatin in Patients With Locally Advanced Cervical Cancer
For Condition: Cervical Cancer
Status: No longer recruiting
Sponsor(s): Radiation Therapy Oncology Group , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/85 Years
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DavidGaffney, Study Chair, Huntsman Cancer Institute
New York Methodist Hospital
Brooklyn, New York, 11215
United States
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, 54449
United States
Regional Radiation Oncology Center at Rome
Rome, Georgia, 30165
United States
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19010
United States
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224
United States
Community Medical Center
Toms River, New Jersey, 08755
United States
UCSF Comprehensive Cancer Center
San Francisco, California, 94143-0128
United States
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital
Mount Holly, New Jersey, 08060
United States
Dixie Regional Medical Center
St. George, Utah, 84770
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1065
United States
Baptist Hospital of Miami
Miami, Florida, 33256-2110
United States
Mills-Peninsula Health Services
Burlingame, California, 94010
United States
Akron City Hospital - Summa Health System
Akron, Ohio, 44304
United States
Memorial Hospital Cancer Center
Colorado Springs, Colorado, 80909
United States
Ball Memorial Hospital Cancer Center
Muncie, Indiana, 47303-3499
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
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
United States
LDS Hospital
Salt Lake City, Utah, 84143
United States
Foundation for Cancer Research and Education
Phoenix, Arizona, 85013
United States
Mobile Infirmary Medical Center
Mobile, Alabama, 36652-2144
United States
South Jersey Regional Cancer Center
Millville, New Jersey, 08332
United States
State University of New York Health Science Center at Brooklyn
Brooklyn, New York, 11203
United States
CCOP - MainLine Health
Wynnewood, Pennsylvania, 19096
United States
Methodist Medical Center of Illinois
Peoria, Illinois, 61636
United States
Monmouth Medical Center
Long Branch, New Jersey, 07740-6395
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Mercy Fitzgerald Hospital
Darby, Pennsylvania, 19023
United States
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha
Omaha, Nebraska, 68114-4199
United States
Paoli Memorial Hospital
Paoli, Pennsylvania, 19301-1792
United States
Newark Beth Israel Medical Center
Newark, New Jersey, 07112
United States
Akron General Medical Center
Akron, Ohio, 44302
United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007
United States
CCOP - Kansas City
Kansas City, Missouri, 64131
United States
Sutter Health Western Division Cancer Research Group
Greenbrae, California, 94904
United States
Additional Information:
Study ID Numbers: CDR0000068849; RTOG-C-0128
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00023660
Other Cervical Cancer Studies:
1. Peripheral Stem Cell Transplantation, White Blood Cell Infusions, Chemotherapy, and Radiation Therapy in Treating Patients With Recurrent Metastatic Cervical or Vaginal Cancer
2. Gene Therapy in Treating Patients With Cancer
3. Fenretinide in Treating Patients With Cervical Neoplasia
4. Whole Body Hyperthermia Combined With Chemotherapy in Treating Patients With Metastatic Breast, Ovarian, Endometrial, or Cervical Cancer
5. EF5 Prior to Surgery or Biopsy in Patients With Breast, Prostate, or Cervical Cancer or High Grade Soft Tissue Sarcoma
Related Studies:
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Radiation Therapy Plus Celecoxib, Fluorouracil, and Cisplatin in Patients With Locally Advanced Cervical Cancer
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