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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

This study is currently Recruiting

March 2011 By National Cancer Institute (NCI)

First Recieved on March 3, 2005

Last Updated on March 31, 2011

Sponsor: Gynecologic Oncology Group
Collaborators: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
Identifier: NCT00104910


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.

Study Type: Interventional
Study Design: Primary Purpose: Treatment


Ages Eligible for Study:18 Years
Genders Eligible for Study:Female
Accepts Healthy Volunteers:No

DISEASE CHARACTERISTICS: - 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 PATIENT CHARACTERISTICS: Age - 18 and over Performance status - GOG 0-1 Life expectancy - Not specified Hematopoietic - Absolute neutrophil count ? 1,500/mm^3 - Platelet count ? 100,000/mm^3 Hepatic - Bilirubin ? 1.5 times upper limit of normal (ULN) - SGOT ? 2.5 times ULN - Alkaline phosphatase ? 2.5 times ULN Renal - Creatinine normal OR - 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 Cardiovascular - No significant cardiac disease within the past 6 months, including any of the following: - Uncontrolled hypertension - Unstable angina - Congestive heart failure - Uncontrolled arrhythmia Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No sensory or motor neuropathy > grade 1 - No septicemia - No severe infection - No circumstance that would preclude study participation or follow-up - No other invasive malignancy within the past 5 years except nonmelanoma skin cancer - No uncontrolled seizure disorder - No active neurologic disease - No history of active collagen vascular disease PRIOR CONCURRENT THERAPY: Biologic therapy - No prior chimerized or murine monoclonal antibody therapy Chemotherapy - No prior cytotoxic chemotherapy for cervical cancer Endocrine therapy - Not specified Radiotherapy - No prior pelvic or abdominal radiotherapy for cervical cancer - No concurrent intensity modulated radiotherapy Surgery - No prior renal transplantation - More than 30 days since prior major surgery (excluding diagnostic biopsy) Other - No other prior therapy for cervical cancer - No prior cancer treatment that would preclude study therapy - No other concurrent investigational agents


  • Investigator: John H. Farley, MD - Study Chair - Uniformed Services University of the Health Sciences
  • Investigator: Russell J. Schilder, MD - - Fox Chase Cancer Center


  • University of Chicago Cancer Research Center

    Chicago, Illinois 60637-1470 United States

  • Holden Comprehensive Cancer Center at University of Iowa

    Iowa City, Iowa 52242-1002 United States

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio 44195 United States

  • MetroHealth Cancer Care Center at MetroHealth Medical Center

    Cleveland, Ohio 44109 United States

  • Riverside Methodist Hospital Cancer Care

    Columbus, Ohio 43214-3998 United States

  • Oklahoma University Cancer Institute

    Oklahoma City, Oklahoma 73104 United States

  • Women and Infants Hospital of Rhode Island

    Providence, Rhode Island 02905 United States

  • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

    Dallas, Texas 75390 United States

  • M. D. Anderson Cancer Center at University of Texas

    Houston, Texas 77030-4009 United States

Conditions related to this trial:

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