Cervical Squamous Cell Carcinoma Clinical Trial
Official title:
A Phase II Evaluation Of OSI-774 (NSC #718781) In The Treatment Of Persistent or Recurrent Squamous Cell Carcinoma Of The Cervix
This phase II trial is studying erlotinib to see how well it works in treating patients with persistent or recurrent cancer of the cervix. Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor
PRIMARY OBJECTIVES:
I. To evaluate the antitumor cytostatic activity of OSI-774 as measured by the probability
of surviving progression-free for at least 6 months in patients with persistent or recurrent
squamous cell carcinoma of the cervix.
II. To determine the nature and degree of toxicity of OSI-774 in this cohort of patients.
SECONDARY OBJECTIVES:
I. To determine the partial and complete response rates in patients with squamous cell
carcinoma of the cervix receiving OSI-774.
II. To determine the duration of progression-free survival and overall survival within this
patient population treated with OSI-774.
III. Assess the effects of prognostic factors: initial performance status and age.
TERTIARY OBJECTIVES:
I. To determine epidermal growth factor receptor (EGFR) and p110 truncated EGFR (p110 sEGFR)
isoform expression levels in primary tumors, and from tumor samples obtained pretreatment
and following four weeks of therapy to determine tumor response (or resistance) to OSI-774
inhibition of the EGFR tyrosine kinase.
II. To correlate EGFR and p110sEGFR expression levels with either MAPK or AKT
phosphorylation status in the same tissue samples obtained pretreatment and following four
weeks of drug treatment to determine downstream effects with response to OSI-774 inhibition
of EGFR.
III. To determine whether pretreatment serum p110 sEGFR concentrations are a useful
prognostic indicator and whether altered and/or sEGFR concentrations are useful indicators
of therapeutic responsiveness, time to progression, and overall survival in cervical
carcinoma patients.
OUTLINE: This is a multicenter study.
Patients receive oral erlotinib once daily for 4 weeks. Courses repeat every 4 weeks in the
absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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