Capecitabine in Treating Patients With Advanced or Recurrent Squamous Cell Carcinoma of the Skin
This phase II trial studies how well capecitabine works in
treating patients with advanced or recurrent squamous cell
carcinoma of the skin. Sponsored by Stanford University in collaboration
with the National Cancer Institute, the drugs tested
are used in chemotherapy, such as capecitabine, and work
in different ways to stop the growth of tumor cells, either by
killing the cells or by stopping them from dividing. The main
objectives of this study are to establish the objective response
rate, using Response Evaluation Criteria in Solid Tumors (RECIST)
criteria, to capecitabine in patients with metastatic or
unresectable/recurrent squamous cell carcinoma of the skin;
and to establish the safety profile, progression free and overall
survival of capecitabine in this patient population. During the
study, the patients receive capecitabine orally (PO) twice daily
(BID) on days 1-14. Courses repeat every 21 days in the absence
of disease progression or unacceptable toxicity. After completion
of study treatment, patients are followed up for 2 years.
To be considered for this study, one must have squamous cell
carcinoma of the skin; patients with "unknown primary lesions"
at the time of diagnosis, if metastatic disease present with a
history of plausible primary skin site removed in the past, are
eligible; for example, patients with squamous cell carcinoma
in neck or parotid lymph nodes with no identifiable mucosal
primary but with a history of the removal of one or more early
stage squamous cell carcinomas of the skin in an anatomically
relevant lymphatic drainage region would be eligible. Patients
also must have measurable disease, defined as at least one lesion
that can be accurately measured in at least one dimension
>= 10 mm with computed tomography (CT) scan, magnetic resonance
imaging (MRI), or calipers by clinical exam.
Exclusion criteria includes patients who are receiving any other
investigational agents or anti-cancer treatments; history of allergic
reactions attributed to compounds of similar chemical or
biologic composition to capecitabine; and uncontrolled concurrent
illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina
pectoris, cardiac arrhythmia, or psychiatric illness/social
situations that would limit compliance with study requirements.
A Pilot Open-Label Study to Examine the Safety and Efficacy of Oral LDE225 in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma Who Have Been Previously Treated With Non-LDE225 Smoothened Inhibitor(s)
Sponsored by Novartis, this is a prospective single-center,
open label, pilot study to investigate the safety and efficacy of
LDE225 in patients with locally advanced or metastatic basal
cell carcinoma. The primary objectives are to explore the effects
of oral LDE225 on the Progression Free Survival (PFS) of
individuals with locally advanced or metastatic BCC who have
been previously treated with a non-LDE225 Smo inhibitor. The
secondary objectives are to evaluate the effect of oral LDE225
on tumor tissue biomarkers of BCC activation (Gii 1, 2, Patched
1,2 and Ki67) in individuals which are non-na"ive to Smo inhibitors
other than LDE225, at baseline and at end-of-treatment to
describe adverse effects of oral LDE225 in individuals with a
history of non-LDE225 Smo inhibitor usage, and to assess the
overall survival rates of individuals with locally advanced BCC
or metastatic BCC who have previously taken a non-LDE225
Smo inhibitor after treatment with LDE225.
Recruitment for this study includes: subjects age 18 years or
older; histologically documented diagnosis of basal cell carcinoma
deemed to be locally advanced or metastatic who have
previously received a non-LDE225 Smo inhibitor; subjects with
a WHO performance status ≤ 2; and at least one measurable
site of disease (as defined by Response Evaluation Criteria in
Solid Tumors), or other disease specific response assessment
criteria, as appropriate.
Exclusions include: patients who have had major surgery
within 4 weeks of initiation of study medication; patients with
concurrent uncontrolled medical conditions that may interfere
with their participation in the study or potentially affect the interpretation
of the study data; patients unable to take oral drugs
