Charlottesville, Virginia 22908

  • Cancer of the Cervix

Purpose:

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.


Study summary:

- 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


Criteria:

Inclusion Criteria: 1. Patients must have signed a Washington University, Human Studies Committee (HSC) approved, informed consent. 2. Patients must have primary, histologically documented FIGO Clinical Stage IB2-IVB invasive carcinoma of the uterine cervix with measurable disease amendable to repeated biopsy. 3. Patients must have an ECOG performance status of 0, 1, or 2 at study entry. 4. 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. 5. 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. 6. Patients must have had no previous treatment for invasive carcinoma of the uterine cervix. 7. Patients must be newly diagnosed with locally advanced or metastatic cervical carcinoma. 8. Bone marrow function: absolute neutrophil count (ANC) ≥ 1,500/mcl; platelets > 100,000/mcl. 9. Renal function: creatinine ≤ 2.0 mg/dl. 10. Hepatic function: bilirubin ≤ 1.5 times upper limit normal (ULN); SGOT ≤ 2.5 times upper limit normal (ULN). 11. Patients with ureteral obstruction must be treated with stent or nephrostomy tube placement. 12. 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). Exclusion Criteria: 1. Acute hepatitis or known HIV. 2. Active or uncontrolled infection. 3. 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. 4. Prior therapy which specifically and directly targets the EGFR pathway. 5. Prior severe infusion reaction to a monoclonal antibody. 6. Any concurrent chemotherapy not indicated in the study protocol or any other investigational agent(s). 7. A serious uncontrolled medical disorder that in the opinion of the Investigator would impair the ability of the subject to receive protocol therapy. 8. Unresolved ureteral obstruction. 9. Renal abnormalities, such as pelvic kidney, horseshoe kidney, or renal transplant, that would require modification of radiation fields. 10. Known or documented brain metastases. 11. 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). 12. Prior radiation therapy to the abdomen and/or pelvis 13. Incarceration


Study is Available At:


Original ID:

IRB-HSR#13748


NCT ID:

NCT00292955


Secondary ID:

CA225243


Study Acronym:


Brief Title:

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


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


Overall Status:

Recruiting


Study Phase:

Phase 2


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Virginia


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificati


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

30


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Linda R. Duska, M.D.
Principal Investigator
University of Virginia
Primary Contact:Meredith Gross, M.S.
434-924-0436
mpg8b@virginia.edu

Study Dates

Start Date:February 2006
Primary Completion Date:February 2011
Primary Completion Type:Anticipated
Verification Date:October 2010
Last Changed Date:October 20, 2010
First Received Date:February 14, 2006

Study Outcomes

Outcome Type:Secondary Outcome
Measure:To determine the progression-free and overall survival in women with locally advanced or metastatic cervical carcinoma treated with concurrent chemoradiation and cetuximab
Time Frame:every three months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:To determine the safety and tolerability of cetuximab with concurrent chemoradiation in women with locally advanced cervical carcinoma
Time Frame:weekly
Safety Issues:True
Outcome Type:Primary Outcome
Measure:To evaluate the validity of fluorodeoxyglucose (FDG) uptake, as determined by positron emission tomography (PET) imaging, as a surrogate marker for response to cetuximab
Time Frame:completion
Safety Issues:False
Outcome Type:Primary Outcome
Measure:To sequence the epidermal growth factor receptor (EGFR) to describe mutations in the receptor that may predict tumor response to cetuximab
Time Frame:completion
Safety Issues:False
Outcome Type:Primary Outcome
Measure:To identify genes that may be identified as predictive of response to cetuximab
Time Frame:completion
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Cetuximab
Description:monotherapy (day 1), then weekly thereafter along with radiation. dose is at 200mg/m2.

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Virginia
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Bristol-Myers Squibb

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: September 24, 2021

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