Status:
UNKNOWN
Cetuximab, Cisplatin, and Radiotherapy in Women With Locally Advanced Cervical Carcinoma
Lead Sponsor:
University of Virginia
Collaborating Sponsors:
Bristol-Myers Squibb
Eli Lilly and Company
Conditions:
Cancer of the Cervix
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The anti-tumor activity of cetuximab prior to chemoradiotherapy and the safety and tolerability of cetuximab with concurrent chemoradiation will be determined in women with locally advanced or metasta...
Detailed Description
* Women with Federation of Gynecology and Obstetrics (FIGO) Clinical Stage IB2-IVB carcinoma of the cervix * Baseline cervical biopsy, blood samples, and FDG-PET/computed tomography (CT) scan * Cetuxi...
Eligibility Criteria
Inclusion
- Patients must have signed a Washington University, Human Studies Committee (HSC) approved, informed consent.
- Patients must have primary, histologically documented FIGO Clinical Stage IB2-IVB invasive carcinoma of the uterine cervix with measurable disease amendable to repeated biopsy.
- Patients must have an ECOG performance status of 0, 1, or 2 at study entry.
- 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.
- 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.
- Patients must have had no previous treatment for invasive carcinoma of the uterine cervix.
- Patients must be newly diagnosed with locally advanced or metastatic cervical carcinoma.
- Bone marrow function: absolute neutrophil count (ANC) ≥ 1,500/mcl; platelets \> 100,000/mcl.
- Renal function: creatinine ≤ 2.0 mg/dl.
- Hepatic function: bilirubin ≤ 1.5 times upper limit normal (ULN); SGOT ≤ 2.5 times upper limit normal (ULN).
- Patients with ureteral obstruction must be treated with stent or nephrostomy tube placement.
- 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
- Acute hepatitis or known HIV.
- Active or uncontrolled infection.
- 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.
- Prior therapy which specifically and directly targets the EGFR pathway.
- Prior severe infusion reaction to a monoclonal antibody.
- Any concurrent chemotherapy not indicated in the study protocol or any other investigational agent(s).
- A serious uncontrolled medical disorder that in the opinion of the Investigator would impair the ability of the subject to receive protocol therapy.
- Unresolved ureteral obstruction.
- Renal abnormalities, such as pelvic kidney, horseshoe kidney, or renal transplant, that would require modification of radiation fields.
- Known or documented brain metastases.
- 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).
- Prior radiation therapy to the abdomen and/or pelvis
- Incarceration
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00292955
Start Date
February 1 2006
Last Update
May 30 2011
Active Locations (2)
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1
Washinton University School of Medicine
St Louis, Missouri, United States, 63110
2
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908