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Cervical CancerPhase 1/2NCT00023660

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

A Phase 1/2 study testing celecoxib, cisplatin and fluorouracil in people with Cervical Cancer, run by Radiation Therapy Oncology Group at 36 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years, women only
Conditions the study is for
Cervical Cancer
What is being tested?
celecoxib, cisplatin and fluorouracil
Type of treatment
Surgery or procedure
How many people
84 participants
Where
36 sitesUnited States
Study dates
Aug 2001to Jan 2005
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

36 sites in 1 country.

36 sites in 1 country

United States36 sites

  • Akron General Medical Center

    Akron, Ohio, 44302

  • Akron City Hospital - Summa Health System

    Akron, Ohio, 44304

  • State University of New York Health Science Center at Brooklyn

    Brooklyn, New York, 11203

  • New York Methodist Hospital

    Brooklyn, New York, 11215

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010

  • Mills-Peninsula Health Services

    Burlingame, California, 94010

  • Memorial Hospital Cancer Center

    Colorado Springs, Colorado, 80909

  • Mercy Fitzgerald Hospital

    Darby, Pennsylvania, 19023

  • Delaware County Memorial Hospital

    Drexel Hill, Pennsylvania, 19026

  • Sutter Health Western Division Cancer Research Group

    Greenbrae, California, 94904

  • University of Texas - MD Anderson Cancer Center

    Houston, Texas, 77030-4009

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • CCOP - Southern Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Monmouth Medical Center

    Long Branch, New Jersey, 07740-6395

  • CCOP - Marshfield Clinic Research Foundation

    Marshfield, Wisconsin, 54449

  • Baptist Hospital of Miami

    Miami, Florida, 33256-2110

  • South Jersey Regional Cancer Center

    Millville, New Jersey, 08332

  • Mobile Infirmary Medical Center

    Mobile, Alabama, 36652-2144

  • Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital

    Mount Holly, New Jersey, 08060

  • Ball Memorial Hospital Cancer Center

    Muncie, Indiana, 47303-3499

  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112

  • Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha

    Omaha, Nebraska, 68114-4199

  • Paoli Memorial Hospital

    Paoli, Pennsylvania, 19301-1792

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61636

  • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

    Philadelphia, Pennsylvania, 19107-5097

  • Foundation for Cancer Research and Education

    Phoenix, Arizona, 85013

  • Western Pennsylvania Hospital

    Pittsburgh, Pennsylvania, 15224

  • Regional Radiation Oncology Center at Rome

    Rome, Georgia, 30165

  • LDS Hospital

    Salt Lake City, Utah, 84143

  • UCSF Comprehensive Cancer Center

    San Francisco, California, 94143-0128

  • Dixie Regional Medical Center

    St. George, Utah, 84770

  • Community Medical Center

    Toms River, New Jersey, 08755

  • Comprehensive Cancer Center at Wake Forest University

    Winston-Salem, North Carolina, 27157-1065

  • CCOP - MainLine Health

    Wynnewood, Pennsylvania, 19096

  • Lankenau Cancer Center at Lankenau Hospital

    Wynnewood, Pennsylvania, 19096

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
Cervical Cancer
Being tested
celecoxib, cisplatin, fluorouracil, brachytherapy, radiation therapy
Keywords
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
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startAug 2001
  3. Primary completionJan 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00023660
Sponsor's protocol ID
RTOG-C-0128
Other IDs
CDR0000068849
Status last verified
Nov 2013
First submitted
13 Sep 2001
Last updated
19 Nov 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Viswanathan AN, Moughan J, Small W Jr, Levenback C, Iyer R, Hymes S, Dicker AP, Miller B, Erickson B, Gaffney DK. The quality of cervical cancer brachytherapy implantation and the impact on local recurrence and disease-free survival in radiation therapy oncology group prospective trials 0116 and 0128. Int J Gynecol Cancer. 2012 Jan;22(1):123-31. doi: 10.1097/IGC.0b013e31823ae3c9.

    PubMed 22193645

  • Weidhaas JB, Li SX, Winter K, Ryu J, Jhingran A, Miller B, Dicker AP, Gaffney D. Changes in gene expression predicting local control in cervical cancer: results from Radiation Therapy Oncology Group 0128. Clin Cancer Res. 2009 Jun 15;15(12):4199-206. doi: 10.1158/1078-0432.CCR-08-2257. Epub 2009 Jun 9.

    PubMed 19509178

  • Zempolich K, Fuhrman C, Milash B, Flinner R, Greven K, Ryu J, Forbes A, Kerlin K, Nichols RC, Gaffney DK. Changes in gene expression induced by chemoradiation in advanced cervical carcinoma: a microarray study of RTOG C-0128. Gynecol Oncol. 2008 May;109(2):275-9. doi: 10.1016/j.ygyno.2008.01.027. Epub 2008 Mar 4.

    PubMed 18299147

  • Gaffney DK, Winter K, Dicker AP, Miller B, Eifel PJ, Ryu J, Avizonis V, Fromm M, Greven K. A Phase II study of acute toxicity for Celebrex (celecoxib) and chemoradiation in patients with locally advanced cervical cancer: primary endpoint analysis of RTOG 0128. Int J Radiat Oncol Biol Phys. 2007 Jan 1;67(1):104-9. doi: 10.1016/j.ijrobp.2006.08.002. Epub 2006 Nov 2.

    PubMed 17084549

  • Gaffney DK, Winter K, Dicker AP, Miller B, Eifel PJ, Ryu J, Avizonis V, Fromm M, Small W, Greven K. Efficacy and patterns of failure for locally advanced cancer of the cervix treated with celebrex (celecoxib) and chemoradiotherapy in RTOG 0128. Int J Radiat Oncol Biol Phys. 2007 Sep 1;69(1):111-7. doi: 10.1016/j.ijrobp.2007.02.050. Epub 2007 May 4.

    PubMed 17482376

  • Gaffney DK, Winter K, Fuhrman C, Flinner R, Greven K, Ryu J, Forbes A, Kerlin K, Nichols RC, Zempolich K. Feasibility of RNA collection for micro-array gene expression analysis in the treatment of cervical carcinoma: a scientific correlate of RTOG C-0128. Gynecol Oncol. 2005 May;97(2):607-11. doi: 10.1016/j.ygyno.2005.01.014.

    PubMed 15863167

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing celecoxib, cisplatin and fluorouracil in people with Cervical Cancer, run by Radiation Therapy Oncology Group at 36 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00023660, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2013.

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