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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00023660
First received: September 13, 2001
Last updated: November 18, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Cervical Cancer
Drug: celecoxib
Drug: cisplatin
Drug: fluorouracil
Radiation: brachytherapy
Radiation: radiation therapy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Radiation Therapy Oncology Group:

Enrollment: 84
Study Start Date: August 2001
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00023660

  Show 36 Study Locations
Sponsors and Collaborators
Radiation Therapy Oncology Group
Investigators
Study Chair: David K. Gaffney, MD, PhD University of Utah
  More Information

Additional Information:
Publications:
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.
Gaffney DK, Winter K, Fuhrman C, et al.: Feasibility of RNA collection for micro-array gene expression analysis in the treatment of cervical carcinoma: a scientific correlate of RTOG C-0128. [Abstract] Int J Radiat Oncol Biol Phys 60 (Suppl 1): A-2239, S479, 2004.

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00023660     History of Changes
Other Study ID Numbers: RTOG-C-0128, CDR0000068849
Study First Received: September 13, 2001
Last Updated: November 18, 2013
Health Authority: United States: Federal Government

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:
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
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing 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

ClinicalTrials.gov processed this record on September 16, 2014