A Phase II Evaluation Of OSI-774 (NSC #718781) In The Treatment Of Persistent or Recurrent Squamous Cell Carcinoma Of The Cervix
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.
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.
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
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
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
At 6 months
Gynecologic Oncology Group
United States: Food and Drug Administration
|Gynecologic Oncology Group||Philadelphia, Pennsylvania 19103|