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Cancer of the CervixPhase 2NCT00292955

Cetuximab, Cisplatin, and Radiotherapy in Women With Locally Advanced Cervical Carcinoma

A Phase 2 study testing Cetuximab in people with Cancer of the Cervix, run by University of Virginia at 2 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The anti-tumor activity of cetuximab prior to chemoradiotherapy and the safety and tolerability of cetuximab with concurrent chemoradiation will be determined in women with locally advanced or metastatic cervical carcinoma. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Cancer of the Cervix
What is being tested?
Cetuximab
How many people
30 participants
Where
2 sitesUnited States
Study dates
Feb 2006to Feb 2012
Phase
Phase 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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have signed a Washington University, Human Studies Committee (HSC) approved, informed consent.
  • Patients must have primary, histologically documented FIGO Clinical Stage IB2-IVB invasive carcinoma of the uterine cervix with measurable disease amendable to repeated biopsy.
  • Patients must have an ECOG performance status of 0, 1, or 2 at study entry.
  • Patients, 18 years and older, must either be not of child bearing potential or have a negative pregnancy test within 7 days of treatment. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal. Women should not breast feed while on this study.
  • Women must have a primary diagnosis of invasive carcinoma of the uterine cervix. Men are excluded from this study as a consequence of the diagnosis being investigated.
  • Patients must have had no previous treatment for invasive carcinoma of the uterine cervix.
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  • Patients must be newly diagnosed with locally advanced or metastatic cervical carcinoma.
  • Bone marrow function: absolute neutrophil count (ANC) ≥ 1,500/mcl; platelets > 100,000/mcl.
  • Renal function: creatinine ≤ 2.0 mg/dl.
  • Hepatic function: bilirubin ≤ 1.5 times upper limit normal (ULN); SGOT ≤ 2.5 times upper limit normal (ULN).
  • Patients with ureteral obstruction must be treated with stent or nephrostomy tube placement.
  • Patients with neuropathy (sensory and motor) must be ≤ grade 1 defined by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (June 10, 2003).

Who cannot join

  • Acute hepatitis or known HIV.
  • Active or uncontrolled infection.
  • Significant history of uncontrolled cardiac disease i.e., uncontrolled hypertension, unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure, and cardiomyopathy with decreased ejection fraction.
  • Prior therapy which specifically and directly targets the EGFR pathway.
  • Prior severe infusion reaction to a monoclonal antibody.
  • Any concurrent chemotherapy not indicated in the study protocol or any other investigational agent(s).
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  • A serious uncontrolled medical disorder that in the opinion of the Investigator would impair the ability of the subject to receive protocol therapy.
  • Unresolved ureteral obstruction.
  • Renal abnormalities, such as pelvic kidney, horseshoe kidney, or renal transplant, that would require modification of radiation fields.
  • Known or documented brain metastases.
  • Any concurrent malignancy other than non-melanoma skin cancer. (Patients with a previous malignancy but without evidence of disease for ≥ 5 years will be allowed to enter the trial).
  • Prior radiation therapy to the abdomen and/or pelvis
  • Incarceration

Trial locations and contacts

2 sites in 1 country.

Meredith Gross, M.S. contact

434-924-0436

mpg8b@virginia.edu

United States2 sites, 1 recruiting

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22908

    Recruiting

  • Washinton University School of Medicine

    St Louis, Missouri, 63110

    Suspended

Other trials in United States

About this study

Official title: An Exploratory Pharmacogenomic Study of Neoadjuvant Cetuximab Followed by Cisplatin, Radiotherapy, and Cetuximab in Women With Newly Diagnosed Locally Advanced or Metastatic Cervical Carcinoma

The anti-tumor activity of cetuximab prior to chemoradiotherapy and the safety and tolerability of cetuximab with concurrent chemoradiation will be determined in women with locally advanced or metastatic cervical carcinoma.

Read the detailed description
  • Women with Federation of Gynecology and Obstetrics (FIGO) Clinical Stage IB2-IVB carcinoma of the cervix
  • Baseline cervical biopsy, blood samples, and FDG-PET/computed tomography (CT) scan
  • Cetuximab 400 mg/m2 on day 1 followed by cetuximab 250 mg/m2 on days 8 and 15
  • Repeat cervical biopsy and FDG-PET/CT scan following cetuximab monotherapy
  • Radiation and weekly cisplatin 40 mg/m2 and cetuximab 250 mg/2 for 6 weeks
  • Cetuximab 250 mg/m2 weekly for 12 weeks
  • Repeat cervical biopsy (if tumor present) and FDG-PET/CT scan after completion of therapy
  • Follow for tumor recurrence and survival
Being tested
Cetuximab
Keywords
Cervical Cancer, Cetuximab, Phase II Clinical Trials, Stage IB2-IVB Carcinoma of the Cervix
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.

  • CetuximabDrug

    monotherapy (day 1), then weekly thereafter along with radiation. dose is at 200mg/m2.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To identify genes that may be identified as predictive of response to cetuximab

    Measured: completion

  2. To sequence the epidermal growth factor receptor (EGFR) to describe mutations in the receptor that may predict tumor response to cetuximab

    Measured: completion

  3. To evaluate the validity of fluorodeoxyglucose (FDG) uptake, as determined by positron emission tomography (PET) imaging, as a surrogate marker for response to cetuximab

    Measured: completion

Secondary outcomes (2)

  1. To determine the safety and tolerability of cetuximab with concurrent chemoradiation in women with locally advanced cervical carcinoma

    Measured: weekly

  2. To determine the progression-free and overall survival in women with locally advanced or metastatic cervical carcinoma treated with concurrent chemoradiation and cetuximab

    Measured: every three months

Timeline

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

  1. First posted16 Feb 2006 (estimated)
  2. Study startFeb 2006
  3. Primary completionFeb 2012 (estimated)

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00292955
Sponsor's protocol ID
IRB-HSR#13748
Other IDs
CA225243, HRPO #05-0702
Status last verified
May 2011
First submitted
14 Feb 2006
Last updated
30 May 2011
Results posted
No

Publications

  • Fracasso PM, Duska LR, Thaker PH, Gao F, Zoberi I, Dehdashti F, Siegel BA, Uliel L, Menias CO, Rehm PK, Goodner SA, Creekmore AN, Lothamer HL, Rader JS. An Exploratory Study of Neoadjuvant Cetuximab Followed by Cetuximab and Chemoradiotherapy in Women With Newly Diagnosed Locally Advanced Cervical Cancer. Am J Clin Oncol. 2022 Jul 1;45(7):286-293. doi: 10.1097/COC.0000000000000926. Epub 2022 Jun 7.

    PubMed 35696702

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cetuximab in people with Cancer of the Cervix, run by University of Virginia at 2 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?

The sponsor lists 12 inclusion and 13 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 30 May 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 phase mean?

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?

Results are not available in the source record.

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

Contact Meredith Gross, M.S. (434-924-0436, mpg8b@virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To identify genes that may be identified as predictive of response to cetuximab (time frame: completion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00292955, which also lists 1 linked publication.

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 30 May 2011.

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