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

Completed · Phase 1

Conditions studied: Cervical Adenocarcinoma, Cervical Adenosquamous 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

In brief

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.

Key facts

Study ID

NCT00104910

Run by

Gynecologic Oncology Group

People needed

64

Starts

2005-01-01

Last updated by the study team

2014-12-31

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed cervical cancer
• Clinical stage IB-IVA disease
• Any cell type allowed
• Positive or negative pelvic and/or para-aortic lymph nodes by radiography
• Unstained sections from primary tumor available
• Performance status - GOG 0-1
• Absolute neutrophil count ≥ 1,500/mm\^3
• Platelet count ≥ 100,000/mm\^3
• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• SGOT ≤ 2.5 times ULN
• Alkaline phosphatase ≤ 2.5 times ULN
• Creatinine normal
• Creatinine clearance > 50 mL/min
• Patients with ureteral obstruction must undergo stent or nephrostomy tube placement prior to study entry
• No renal abnormality (e.g., pelvic kidney or horseshoe kidney) that would require modification of radiation fields
• No significant cardiac disease within the past 6 months, including any of the following:
• Uncontrolled hypertension
• Unstable angina
• Congestive heart failure
• Uncontrolled arrhythmia
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No sensory or motor neuropathy > grade 1
• No septicemia

Where it is running

• Georgia Regents University Medical Center — Augusta, Georgia, United States
• University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States
• Indiana University/Melvin and Bren Simon Cancer Center — Indianapolis, Indiana, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• Johns Hopkins University/Sidney Kimmel Comprehensive Cancer Center — Baltimore, Maryland, United States
• Cooper Hospital University Medical Center — Camden, New Jersey, United States
• MetroHealth Medical Center — Cleveland, Ohio, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Riverside Methodist Hospital — Columbus, Ohio, United States
• Lake University Ireland Cancer Center — Mentor, Ohio, United States
• University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
• Women and Infants Hospital — Providence, Rhode Island, United States
• Parkland Memorial Hospital — Dallas, Texas, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• M D Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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