Radiation Therapy Plus Celecoxib, Fluorouracil, and Cisplatin in Patients With Locally Advanced Cervical Cancer
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| ClinicalTrials.gov Identifier: NCT00023660 |
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Recruitment Status :
Completed
First Posted : January 27, 2003
Last Update Posted : November 19, 2013
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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 |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 84 participants |
| 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 : | August 2001 |
| Actual Primary Completion Date : | January 2005 |
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| Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00023660
Show 36 Study Locations
| Study Chair: | David K. Gaffney, MD, PhD | University of Utah |
Publications of Results:
Other Publications:
| Responsible Party: | Radiation Therapy Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00023660 History of Changes |
| Other Study ID Numbers: |
RTOG-C-0128 CDR0000068849 |
| First Posted: | January 27, 2003 Key Record Dates |
| Last Update Posted: | November 19, 2013 |
| Last Verified: | November 2013 |
Keywords provided by Radiation Therapy Oncology Group:
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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 |
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female Cisplatin Fluorouracil Celecoxib Antineoplastic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action |
Antimetabolites, Antineoplastic Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Cyclooxygenase 2 Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Anti-Inflammatory Agents Antirheumatic Agents |