Capecitabine in Treating Patients With Advanced or Recurrent Squamous Cell Carcinoma of the Skin

Squamous Cell Carcinoma of the Skin Clinical Trial

Official title:

A Phase 2 Study of Capecitabine in Patients With Advanced or Recurrent Squamous Cell Carcinoma of the Skin

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01823679
• Other study ID #: IRB-26699
• Secondary ID: NCI-2013-00710SK
• Status: Terminated
• Phase: Phase 2
• First received: March 29, 2013
• Last updated: March 15, 2018
• Start date: March 2013
• Est. completion date: May 2014

Study information

• Verified date: March 2018
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Phase 2 evaluation of capecitabine in patients with advanced or recurrent squamous cell carcinoma of the skin.

Description:

Participants are to receive 500 mg/m² of capecitabine orally (PO) twice daily (BID) on days 1 to 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

INCLUSION CRITERIA

• Squamous cell carcinoma of the skin or "unknown primary lesions" at the time of diagnosis if metastatic disease present with a history of plausible primary skin site removed in the past. Example: 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

• Measurable disease, defined as at least 1 lesion that can be accurately measured in at least 1 dimension as = 10 mm with computed tomography (CT) scan; magnetic resonance imaging (MRI); or calipers during clinical exam

• Eastern Cooperative Oncology Group (ECOG) performance status = 2 (Karnofsky = 60%)

• Life expectancy greater than 3 months

• Absolute neutrophil count = 1,000/mcL

• Platelets = 100,000/mcL

• Total bilirubin

• Within normal institutional limits OR

• = 2 x upper limit of normal (ULN) if participant has Gilbert's syndrome (elevated unconjugated bilirubin from decreased UDP glucuronosyltransferase 1 family, polypeptide A1 [UGT1A1] activity)

• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) = 2.5 x institutional ULN or up to 5 X ULN if known to be caused by liver metastases

• Creatinine OR

• < 1.3 mg/dL OR

• Creatinine clearance = 30 mL/min/1.73 m2 for patients with creatinine levels above institutional normal (Note creatinine clearances between 30 and 49 mg/dL necessitate dose modification)

• For participants with a history of coronary artery disease (CAD)/myocardial infarction (MI) or congestive heart failure (CHF), ejection fraction (EF) = 50% by multi-gated acquisition (MUGA) or echocardiogram (exceptions by PI discretion)

EXCLUSION CRITERIA

• Prior treatment with systemic capecitabine or prodrugs

• Prior treatment with systemic fluorouracil (5-FU) or prodrugs (prior topical treatment with 5FU is permitted if recovered from any toxicities > grade 1, and after at least 5 half-lives of the last systemically administered agent have passed)

• Receiving any other investigational agents or anti-cancer treatments

• Candidates for curative locoregional treatment (patients with recurrent locoregional disease following surgery and/ or radiation for which a resection is unacceptably morbid and unlikely to be curative are eligible)

• History of allergic reactions attributed to compounds of similar chemical or biologic composition to capecitabine

• Uncontrolled concurrent illness including, but not limited to:

• Ongoing or active infection

• Symptomatic congestive heart failure

• Unstable angina pectoris

• Cardiac arrhythmia

• Psychiatric illness/social situations that would limit compliance with study requirements

• Pregnant

• Lactating

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Recurrent Skin Cancer
• Skin Neoplasms
• Squamous Cell Carcinoma of the Skin

Intervention

Drug:
• Capecitabine
Given orally

Locations

Country	Name	City	State
United States	Stanford University Hospitals and Clinics	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate (ORR)	Response assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)	9 weeks (3 cycles)
Secondary	Progression-free Survival (PFS) at 1 Year	Proportion of participants with progression-free survival (PFS) at 1 year, as calculated based on Kaplan-Meier estimates.	1 year
Secondary	Progression-free Survival (PFS) at 2 Years	Proportion of participants with progression-free survival (PFS) at 2 years, as calculated based on Kaplan-Meier estimates.	2 years
Secondary	Overall Survival (OS) at 1 Year	Proportion of participants with overall survival (OS) at 1 year, as calculated based on Kaplan-Meier estimates.	1 year
Secondary	Overall Survival (OS) at 2 Years	Proportion of participants with overall survival (OS) at 2 years, as calculated based on Kaplan-Meier estimates.	2 years