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

Study:

A Phase I Trial of Tailored Radiation Therapy With Concomitant Cetuximab (C225, NSC #714692) and Cisplatin (NSC #119875) in the Treatment of Patients With Cervical Cancer

Rationale:

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.

Purpose:

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.

Study Status: Completed

Recruiting:
n/a

Condition Intervention Phase
Cervical Adenocarcinoma
Cervical Adenosquamous Cell Carcinoma
Cervical Small Cell Carcinoma
Cervical Squamous Cell Carcinoma
Stage IB Cervical Cancer
Stage IIA Cervical Cancer
Stage IIB Cervical Cancer
Stage III Cervical Cancer
Stage IVA Cervical Cancer
Radiation: brachytherapy
Radiation: 3-dimensional conformal radiation therapy
Biological: cetuximab
Drug: cisplatin
Phase 1

Verified by Gynecologic Oncology Group December, 2013

Sponsored by: Gynecologic Oncology Group
Information provided by: Gynecologic Oncology Group
ClinicalTrials.gov identifier: NCT00104910

Study Type: Interventional

Study Design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States

Kathleen Moore., Principal Investigator

This information is abridged to display results relevant only to Cleveland Clinic. To see complete record visit ClinicalTrials.gov
  Information obtained from ClinicalTrials.gov on
Link to the current ClinicalTrials.gov record.

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