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NCT00104910 · ClinicalTrials.gov registry record · Phase 1

Cetuximab, Cisplatin, and Radiation Therapy in Treating Patients With Stage IB, Stage II, Stage III, or Stage IVA Cervical Cancer

A Phase 1 study of Cervical Squamous Cell Carcinoma and Cervical Adenocarcinoma, sponsored by Gynecologic Oncology Group.

Completed
Registry status
Phase 1
Development phase
64
Enrollment target
15
Study locations

NCT00104910 is a Phase 1 study of Cervical Squamous Cell Carcinoma and Cervical Adenocarcinoma that has completed, run by Gynecologic Oncology Group. The registered enrollment target is 64 participants, below the 118-participant average among 13 other Cervical Squamous Cell Carcinoma trials with a reported enrollment target (46% lower). The trial reports 15 study locations across 10 states.

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The verdict

NCT00104910, a Phase 1 study of Cervical Squamous Cell Carcinoma and Cervical Adenocarcinoma, has completed, sponsored by Gynecologic Oncology Group.

COMPLETED
Registry status
Phase 1
Development phase
64 participants
Enrollment target
15
Study locations

Study Summary

This phase I trial is studying the side effects and best dose of cetuximab when given together with cisplatin and radiation therapy in treating patients with stage IB, stage II, stage III, or stage IVA cervical cancer. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving cetuximab together with cisplatin and radiation therapy may kill more tumor cells.

Interventions

  • DRUG Cisplatin
  • BIOLOGICAL Cetuximab
  • RADIATION 3-Dimensional Conformal Radiation Therapy
  • RADIATION Internal Radiation Therapy

Study Locations (15)

Ohio

  • MetroHealth Medical Center - Cleveland
  • Cleveland Clinic Foundation - Cleveland
  • Riverside Methodist Hospital - Columbus
  • Lake University Ireland Cancer Center - Mentor

Texas

  • Parkland Memorial Hospital - Dallas
  • University of Texas Southwestern Medical Center - Dallas
  • M D Anderson Cancer Center - Houston

Georgia

  • Georgia Regents University Medical Center - Augusta

Illinois

  • University of Chicago Comprehensive Cancer Center - Chicago

Indiana

  • Indiana University/Melvin and Bren Simon Cancer Center - Indianapolis

Iowa

  • University of Iowa Hospitals and Clinics - Iowa City

Maryland

  • Johns Hopkins University/Sidney Kimmel Comprehensive Cancer Center - Baltimore

New Jersey

  • Cooper Hospital University Medical Center - Camden

Trial Details

FieldValue
Enrollment Target 64 participants
Start Date 2005-01
Phase Phase 1

Sponsor

Gynecologic Oncology Group

154 total trials

What the Registry Record Tells You About NCT00104910

The ClinicalTrials.gov registry entry for NCT00104910 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 64 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 118-participant average among 13 other Cervical Squamous Cell Carcinoma trials with a reported enrollment target (46% lower). The listed sponsor is Gynecologic Oncology Group, which has 154 total studies on file at ClinicalTrials.gov.

The record links to 9 conditions, with Cervical Squamous Cell Carcinoma appearing as the primary indexed condition, and to 4 interventions - of which Cisplatin is the first listed.

NCT00104910 reports 15 study locations spanning 10 distinct geographic areas - top geographies include Ohio, Texas, Georgia.

Frequently Asked Questions

What is clinical trial NCT00104910 about?

NCT00104910 is a clinical study titled "Cetuximab, Cisplatin, and Radiation Therapy in Treating Patients With Stage IB, Stage II, Stage III, or Stage IVA Cervical Cancer". This phase I trial is studying the side effects and best dose of cetuximab when given together with cisplatin and radiation therapy in treating patients with stage IB, stage II, stage III, or stage IVA cervical cancer. Monoclonal antibodies, such as cetuximab, can block tumor growth in different way...

What is the current status of trial NCT00104910?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 64 participants. The study started on 2005-01.

What conditions does trial NCT00104910 study?

This clinical trial studies the following conditions: Cervical Squamous Cell Carcinoma, Cervical Adenocarcinoma, Cervical Adenosquamous Carcinoma, Cervical Small Cell Carcinoma, Stage IVA Cervical Cancer.

What interventions are being tested in trial NCT00104910?

The interventions under investigation include: Cisplatin (DRUG), Cetuximab (BIOLOGICAL), 3-Dimensional Conformal Radiation Therapy (RADIATION), Internal Radiation Therapy (RADIATION).

Who is sponsoring clinical trial NCT00104910?

This trial is sponsored by Gynecologic Oncology Group, which has 154 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00104910 being conducted?

This trial has 15 study locations across Georgia, Illinois, Indiana, Iowa, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.