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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00292955 |
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Date of registration:
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14/02/2006 |
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Primary sponsor: |
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Public title:
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Cetuximab, Cisplatin, and Radiotherapy in Women With Locally Advanced Cervical Carcinoma
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Scientific title:
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An Exploratory Pharmacogenomic Study of Neoadjuvant Cetuximab Followed by Cisplatin, Radiotherapy, and Cetuximab in Women With Newly Diagnosed Locally Advanced or Metastatic Cervical Carcinoma |
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Date of first enrolment:
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February 2006 |
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Target sample size:
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30 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00292955 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Meredith Gross, M.S. |
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Address:
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Telephone:
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434-924-0436 |
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Email:
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mpg8b@virginia.edu |
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Affiliation:
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Name:
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Linda R. Duska, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Virginia |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Patients must have signed a Washington University, Human Studies Committee (HSC)
approved, informed consent.
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:
1. Acute hepatitis or known HIV.
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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Cancer of the Cervix
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Intervention(s)
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Drug: Cetuximab
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Primary Outcome(s)
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To evaluate the validity of fluorodeoxyglucose (FDG) uptake, as determined by positron emission tomography (PET) imaging, as a surrogate marker for response to cetuximab
[Time Frame: completion]
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To identify genes that may be identified as predictive of response to cetuximab
[Time Frame: completion]
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To sequence the epidermal growth factor receptor (EGFR) to describe mutations in the receptor that may predict tumor response to cetuximab
[Time Frame: completion]
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Secondary Outcome(s)
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To determine the progression-free and overall survival in women with locally advanced or metastatic cervical carcinoma treated with concurrent chemoradiation and cetuximab
[Time Frame: every three months]
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To determine the safety and tolerability of cetuximab with concurrent chemoradiation in women with locally advanced cervical carcinoma
[Time Frame: weekly]
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Secondary ID(s)
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CA225243
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HRPO #05-0702
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IRB-HSR#13748
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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