← Back to Search

Monoclonal Antibodies

Chemoradiotherapy for Advanced Cervical Cancer

Phase 2

Waitlist Available

Led By Linda R. Duska, M.D.

Research Sponsored by University of Virginia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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 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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every three months

Awards & highlights

Study Summary

This trial will test if a cancer drug is effective when used before chemoradiotherapy, and how well people tolerate the drug when it is used with chemoradiation.

Who is the study for?

This trial is for women with a confirmed diagnosis of invasive cervical cancer that's advanced or spread, who haven't had previous treatments. They must be over 18, not pregnant, and have good organ function. Men and those with certain medical conditions like acute hepatitis, HIV, or uncontrolled diseases are excluded.Check my eligibility

What is being tested?

The study tests the effectiveness of cetuximab (a drug targeting cancer cells) before chemoradiotherapy in women with advanced cervical cancer. It also assesses how safe it is to use cetuximab alongside standard chemotherapy and radiation treatment.See study design

What are the potential side effects?

Cetuximab can cause skin reactions, low magnesium levels, infusion-related reactions like fever or chills, and rarely serious lung problems. Chemotherapy and radiotherapy may lead to fatigue, nausea, hair loss, blood cell changes increasing infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a woman diagnosed with invasive cervical cancer.

Select...

My nerve damage symptoms are mild.

Select...

I have a tube or stent for my blocked ureter.

Select...

My cervical cancer is confirmed and can be measured and biopsied.

Select...

I am able to care for myself and perform daily activities.

Select...

I have not received any treatment for invasive cervical cancer.

Select...

I have been recently diagnosed with advanced or spreading cervical cancer.

Select...

My blood tests show normal white blood cell and platelet counts.

Select...

My creatinine level is 2.0 mg/dl or lower.

Select...

My liver tests are within the required range.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every three months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every three months

This trial's timeline: 3 weeks for screening, Varies for treatment, and every three months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

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

Secondary outcome measures

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

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

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyIndustry Sponsor

2,613 Previous Clinical Trials

3,200,899 Total Patients Enrolled

Washington University School of MedicineOTHER

1,931 Previous Clinical Trials

2,299,679 Total Patients Enrolled

University of VirginiaLead Sponsor

753 Previous Clinical Trials

1,245,001 Total Patients Enrolled

Media Library

Cetuximab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT00292955 — Phase 2

Cervical Cancer Clinical Trial 2023: Cetuximab Highlights & Side Effects. Trial Name: NCT00292955 — Phase 2

Cetuximab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00292955 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has recruitment for this trial commenced?

"According to the data on clinicaltrials.gov, this medical trial is no longer recruiting patients after its most recent update in May 2011. There still remain 2749 other studies with open enrollment at present."

Answered by AI

What possible risks could patients face by undergoing this therapeutic procedure?

"Due to the fact that this is a Phase 2 clinical trial, there are some evidence-based safety assessments in place but no existing data validating its efficacy. As such, our team has assigned it an arbitrary value of 2 on a 1-3 scale."

Answered by AI

Recent research and studies

American Journal of Clinical OncologyJournal

An Exploratory Study of Neoadjuvant Cetuximab Followed by Cetuximab and Chemoradiotherapy in Women with Newly Diagnosed Locally Advanced Cervical Cancer

Fracasso, Paula M., Linda R. Duska, Premal H. Thaker, Feng Gao, Imran Zoberi, Farrokh Dehdashti, Barry A. Siegel, et al.. 2022. “An Exploratory Study of Neoadjuvant Cetuximab Followed by Cetuximab and Chemoradiotherapy in Women with Newly Diagnosed Locally Advanced Cervical Cancer”. American Journal of Clinical Oncology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/coc.0000000000000926.

American Journal of Clinical OncologyJournal

An Exploratory Study of Neoadjuvant Cetuximab Followed by Cetuximab and Chemoradiotherapy in Women with Newly Diagnosed Locally Advanced Cervical Cancer

clinicaltrials.govStudy

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

2006. "Cetuximab, Cisplatin, and Radiotherapy in Women With Locally Advanced Cervical Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00292955.

All > Basal Cell Carcinoma > Virginia