Cetuximab, Cisplatin, and Radiation Therapy in Treating Patients With Stage IB, Stage II, Stage III, or Stage IVA Cervical Cancer
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First Received Date ICMJE | March 3, 2005 | ||||||||
Last Updated Date | July 18, 2012 | ||||||||
Start Date ICMJE | April 2005 | ||||||||
Estimated Primary Completion Date | January 2013 (final data collection date for primary outcome measure) | ||||||||
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Change History | Complete list of historical versions of study NCT00104910 on ClinicalTrials.gov Archive Site | ||||||||
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Descriptive Information | |||||||||
Brief Title ICMJE | Cetuximab, Cisplatin, and Radiation Therapy in Treating Patients With Stage IB, Stage II, Stage III, or Stage IVA Cervical Cancer | ||||||||
Official Title ICMJE | 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 | ||||||||
Brief Summary | 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. |
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Detailed Description | 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. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase | Phase 1 | ||||||||
Study Design ICMJE | Primary Purpose: Treatment | ||||||||
Condition ICMJE | Cervical Cancer | ||||||||
Intervention ICMJE |
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Study Arm (s) | |||||||||
Publications * | |||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Active, not recruiting | ||||||||
Estimated Enrollment ICMJE | 100 | ||||||||
Completion Date | |||||||||
Estimated Primary Completion Date | January 2013 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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Gender | Female | ||||||||
Ages | 18 Years and older | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
Location Countries ICMJE | United States | ||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT00104910 | ||||||||
Other Study ID Numbers ICMJE | CDR0000413880, GOG-9918 | ||||||||
Has Data Monitoring Committee | |||||||||
Responsible Party | |||||||||
Study Sponsor ICMJE | Gynecologic Oncology Group | ||||||||
Collaborators ICMJE | National Cancer Institute (NCI) | ||||||||
Investigators ICMJE |
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Information Provided By | National Cancer Institute (NCI) | ||||||||
Verification Date | October 2011 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |