NCT00292955

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

February 14, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 16, 2006

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Last Updated

May 30, 2011

Status Verified

May 1, 2011

Enrollment Period

6 years

First QC Date

February 14, 2006

Last Update Submit

May 26, 2011

Conditions

Cancer of the Cervix

Keywords

Cervical Cancer, Cetuximab, Phase II Clinical TrialsStage IB2-IVB Carcinoma of the Cervix

Outcome Measures

Primary Outcomes (3)

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

    completion

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

    completion

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

    completion

Secondary Outcomes (2)

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

    weekly

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

    every three months

Interventions

CetuximabDRUG

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

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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).

You may not qualify if:

  • 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).
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Washinton University School of Medicine

St Louis, Missouri, 63110, United States

SUSPENDED

University of Virginia Cancer Center

Charlottesville, Virginia, 22908, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 35696702DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Cetuximab

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Linda R. Duska, M.D.

    University of Virginia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Meredith Gross, M.S.

CONTACT

434-924-0436mpg8b@virginia.edu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 14, 2006

First Posted

February 16, 2006

Study Start

February 1, 2006

Primary Completion

February 1, 2012

Last Updated

May 30, 2011

Record last verified: 2011-05

Locations

US(2)