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

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ClinicalTrials.gov Identifier: NCT00023660
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : November 19, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Radiation Therapy Oncology Group

Study Description
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Brief Summary:

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

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.


Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer
Drug Information available for: Celecoxib

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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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
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
Contacts and Locations
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Information from the National Library of Medicine

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
Sponsors and Collaborators
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
Investigators
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Study Chair: David K. Gaffney, MD, PhD University of Utah
More Information
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Publications of Results:
Gaffney DK, Winter K, Dicker AP, et al.: Celebrex™ (celecoxib) and chemoradiation in patients with locally advanced cervical cancer. an efficacy report of RTOG 0128. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-70, S41, 2006.
Gaffney DK, Winter K, Dicker A, et al.: A phase I-II study of COX-2 inhibitor, celebrex (celecoxib) and chemoradiation in patients with locally advanced cervical cancer: primary endpoint analysis of RTOG 0128. [Abstract] Int J Radiat Oncol Biol Phys 63 (2 Suppl 1): A-155, S93, 2005.
Zempolich K, Milash B, Fuhrman C, et al.: Changes in gene expression induced by chemoradiation in advanced cervical carcinoma: a microarray study of RTOG C-0128. [Abstract] Int J Radiat Oncol Biol Phys 63 (2 Suppl 1): A-159, S96, 2005.

Other Publications:

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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:
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
Celecoxib
Cisplatin
Fluorouracil
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
 Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors