Cervical Adenocarcinoma Clinical Trial
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
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.
PRIMARY OBJECTIVES:
I. Determine the maximum tolerated dose or safe biologically effective dose of cetuximab
when administered in combination with cisplatin, external beam radiotherapy, and
brachytherapy in patients with stage IB-IVA cervical cancer.
II. Determine the feasibility of this regimen, in terms of chronic and acute toxic effects,
in these patients.
SECONDARY OBJECTIVES:
I. Determine the distribution of progression-free survival and overall survival of patients
treated with this regimen at 1 year after study entry.
II. Determine the site of recurrence (locoregional vs distant) in patients treated with this
regimen up to 1 year after study entry.
III. Correlate response or progression-free survival with epidermal growth factor receptor
expression in tumor samples from patients treated with this regimen at 1 year after study
entry.
IV. Correlate response or progression-free survival with grade of cetuximab-induced rash in
patients treated with this regimen at 1 year after study entry.
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.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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