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Sponsors and Collaborators: |
Gynecologic Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov 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.
Condition | Intervention | Phase |
---|---|---|
Cervical Cancer |
Biological: cetuximab Drug: cisplatin Radiation: brachytherapy Radiation: radiation therapy |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | 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 |
Estimated Enrollment: | 100 |
Study Start Date: | April 2005 |
Estimated Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, dose-escalation study of cetuximab. Patients are stratified according to nodal status (positive para-aortic and/or pelvic lymph nodes vs negative para-aortic and pelvic lymph nodes).
Patients receive cetuximab IV over 1-2 hours and cisplatin IV on days 1, 8, 15, 22, 29, and 36 (weeks 1-6). Patients also undergo external beam radiotherapy to the para-aortic and pelvic lymph nodes OR whole pelvis once daily on days 1-5, 8-12, 15-19, 22-26, and 29-33 (weeks 1-5). Patients then receive either 1 or 2 applications of low-dose rate brachytherapy in weeks 6-8 OR 5 applications of high-dose rate (HDR)* brachytherapy once weekly in weeks 4-8. Treatment continues in the absence of disease progression or unacceptable toxicity.
NOTE: *No external beam radiotherapy is administered on the day of HDR brachytherapy. If the majority of external beam radiotherapy has been administered, HDR brachytherapy may be administered in 2 applications per week (separated by at least 72 hours) in order to complete all treatment within 8 weeks.
Cohorts of 3-6 patients per stratum receive escalating doses of cetuximab until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
After completion of study treatment, patients are followed every 3 months for 1 year.
PROJECTED ACCRUAL: Approximately 30-100 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed cervical cancer
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
No significant cardiac disease within the past 6 months, including any of the following:
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Illinois | |
University of Chicago Cancer Research Center | Recruiting |
Chicago, Illinois, United States, 60637-1470 | |
Contact: Clinical Trials Office - University of Chicago Cancer Research 773-834-7424 | |
United States, Iowa | |
Holden Comprehensive Cancer Center at University of Iowa | Recruiting |
Iowa City, Iowa, United States, 52242-1002 | |
Contact: Cancer Information Service 800-237-1225 | |
United States, Maryland | |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting |
Baltimore, Maryland, United States, 21231-2410 | |
Contact: Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Ce 410-955-8804 jhcccro@jhmi.edu | |
United States, New Mexico | |
University of New Mexico Cancer Center | Recruiting |
Albuquerque, New Mexico, United States, 87131-5636 | |
Contact: Clinical Trials Office - University of New Mexico Cancer Cente 505-272-6972 | |
United States, Ohio | |
Case Comprehensive Cancer Center | Recruiting |
Cleveland, Ohio, United States, 44106-5065 | |
Contact: Clinical Trials Office - Case Comprehensive Cancer Center 800-641-2422 | |
Cleveland Clinic Taussig Cancer Center | Recruiting |
Cleveland, Ohio, United States, 44195 | |
Contact: Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente 866-223-8100 | |
MetroHealth Cancer Care Center at MetroHealth Medical Center | Recruiting |
Cleveland, Ohio, United States, 44109 | |
Contact: Peter G. Rose, MD 216-444-1712 | |
Riverside Methodist Hospital Cancer Care | Recruiting |
Columbus, Ohio, United States, 43214-3998 | |
Contact: Clinical Trials Office - Riverside Methodist Hospital Cancer C 614-566-4475 | |
United States, Oklahoma | |
Oklahoma University Cancer Institute | Recruiting |
Oklahoma City, Oklahoma, United States, 73104 | |
Contact: Robert G. Mennel 405-271-6822 | |
United States, Texas | |
M. D. Anderson Cancer Center at University of Texas | Recruiting |
Houston, Texas, United States, 77030-4009 | |
Contact: Clinical Trials Office - M. D. Anderson Cancer Center at the U 713-792-3245 | |
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Recruiting |
Dallas, Texas, United States, 75390 | |
Contact: Clinical Trials Office - Simmons Comprehensive Cancer Center a 866-460-4673; 214-648-7097 | |
United States, Virginia | |
Virginia Commonwealth University Massey Cancer Center | Recruiting |
Richmond, Virginia, United States, 23298-0037 | |
Contact: Clinical Trials Office -Virginia Commonwealth University Masse 804-628-1939 | |
United States, Wisconsin | |
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Recruiting |
Madison, Wisconsin, United States, 53792-6164 | |
Contact: Clinical Trials Office - University of Wisconsin Paul P. Carbo 608-262-5223 |
Study Chair: | John H. Farley, MD | Uniformed Services University of the Health Sciences |
Investigator: | Russell J. Schilder, MD | Fox Chase Cancer Center |
Study ID Numbers: | CDR0000413880, GOG-9918 |
Study First Received: | March 3, 2005 |
Last Updated: | April 18, 2009 |
ClinicalTrials.gov Identifier: | NCT00104910 History of Changes |
Health Authority: | Unspecified |
cervical adenocarcinoma cervical adenosquamous cell carcinoma cervical squamous cell carcinoma cervical small cell carcinoma stage IB cervical cancer |
stage IIA cervical cancer stage IIB cervical cancer stage III cervical cancer stage IVA cervical cancer |
Carcinoma, Small Cell Radiation-Sensitizing Agents Cisplatin Cetuximab Epidermoid Carcinoma |
Squamous Cell Carcinoma Adenocarcinoma Carcinoma, Squamous Cell Carcinoma, Adenosquamous Carcinoma |
Radiation-Sensitizing Agents Cisplatin Antineoplastic Agents Therapeutic Uses |
Physiological Effects of Drugs Cetuximab Pharmacologic Actions |