Cetuximab, Cisplatin, and Radiotherapy in Women With Locally Advanced Cervical Carcinoma
NCT ID: NCT00292955
Last Updated: 2011-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
30 participants
INTERVENTIONAL
2006-02-28
Brief Summary
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Detailed Description
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* Baseline cervical biopsy, blood samples, and FDG-PET/computed tomography (CT) scan
* Cetuximab 400 mg/m2 on day 1 followed by cetuximab 250 mg/m2 on days 8 and 15
* Repeat cervical biopsy and FDG-PET/CT scan following cetuximab monotherapy
* Radiation and weekly cisplatin 40 mg/m2 and cetuximab 250 mg/2 for 6 weeks
* Cetuximab 250 mg/m2 weekly for 12 weeks
* Repeat cervical biopsy (if tumor present) and FDG-PET/CT scan after completion of therapy
* Follow for tumor recurrence and survival
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Cetuximab
monotherapy (day 1), then weekly thereafter along with radiation. dose is at 200mg/m2.
Eligibility Criteria
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Inclusion Criteria
2. Patients must have primary, histologically documented FIGO Clinical Stage IB2-IVB invasive carcinoma of the uterine cervix with measurable disease amendable to repeated biopsy.
3. Patients must have an ECOG performance status of 0, 1, or 2 at study entry.
4. Patients, 18 years and older, must either be not of child bearing potential or have a negative pregnancy test within 7 days of treatment. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal. Women should not breast feed while on this study.
5. Women must have a primary diagnosis of invasive carcinoma of the uterine cervix. Men are excluded from this study as a consequence of the diagnosis being investigated.
6. Patients must have had no previous treatment for invasive carcinoma of the uterine cervix.
7. Patients must be newly diagnosed with locally advanced or metastatic cervical carcinoma.
8. Bone marrow function: absolute neutrophil count (ANC) ≥ 1,500/mcl; platelets \> 100,000/mcl.
9. Renal function: creatinine ≤ 2.0 mg/dl.
10. Hepatic function: bilirubin ≤ 1.5 times upper limit normal (ULN); SGOT ≤ 2.5 times upper limit normal (ULN).
11. Patients with ureteral obstruction must be treated with stent or nephrostomy tube placement.
12. Patients with neuropathy (sensory and motor) must be ≤ grade 1 defined by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (June 10, 2003).
Exclusion Criteria
2. Active or uncontrolled infection.
3. Significant history of uncontrolled cardiac disease i.e., uncontrolled hypertension, unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure, and cardiomyopathy with decreased ejection fraction.
4. Prior therapy which specifically and directly targets the EGFR pathway.
5. Prior severe infusion reaction to a monoclonal antibody.
6. Any concurrent chemotherapy not indicated in the study protocol or any other investigational agent(s).
7. A serious uncontrolled medical disorder that in the opinion of the Investigator would impair the ability of the subject to receive protocol therapy.
8. Unresolved ureteral obstruction.
9. Renal abnormalities, such as pelvic kidney, horseshoe kidney, or renal transplant, that would require modification of radiation fields.
10. Known or documented brain metastases.
11. Any concurrent malignancy other than non-melanoma skin cancer. (Patients with a previous malignancy but without evidence of disease for ≥ 5 years will be allowed to enter the trial).
12. Prior radiation therapy to the abdomen and/or pelvis
13. Incarceration
18 Years
FEMALE
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Eli Lilly and Company
INDUSTRY
Washington University School of Medicine
OTHER
University of Virginia
OTHER
Responsible Party
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University of Virginia
Principal Investigators
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Linda R. Duska, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Virginia
Locations
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Washinton University School of Medicine
St Louis, Missouri, United States
University of Virginia Cancer Center
Charlottesville, Virginia, United States
Countries
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Central Contacts
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References
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Fracasso PM, Duska LR, Thaker PH, Gao F, Zoberi I, Dehdashti F, Siegel BA, Uliel L, Menias CO, Rehm PK, Goodner SA, Creekmore AN, Lothamer HL, Rader JS. An Exploratory Study of Neoadjuvant Cetuximab Followed by Cetuximab and Chemoradiotherapy in Women With Newly Diagnosed Locally Advanced Cervical Cancer. Am J Clin Oncol. 2022 Jul 1;45(7):286-293. doi: 10.1097/COC.0000000000000926. Epub 2022 Jun 7.
Other Identifiers
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CA225243
Identifier Type: -
Identifier Source: secondary_id
HRPO #05-0702
Identifier Type: -
Identifier Source: secondary_id
IRB-HSR#13748
Identifier Type: -
Identifier Source: org_study_id