Clinical Trial Review

August 2013 | Volume 12 | Issue 8 | Feature | 959 | Copyright © 2013

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Abstract

Clinical Trial Review is a JDD department designed to provide physicians with information on drugs and devices undergoing clinical testing. It is our goal to inform the reader of the status of select drug and device studies relevant to the practice of dermatology before this information is available through standard channels. To participate in or learn more about these and additional trials, visit www.clinicaltrials.gov.

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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.

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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

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