Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01823679
Recruitment Status : Terminated (Low accrual)
First Posted : April 4, 2013
Results First Posted : March 10, 2017
Last Update Posted : April 12, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
A. Dimitrios Colevas, Stanford University

Tracking Information
First Submitted Date  ICMJE March 29, 2013
First Posted Date  ICMJE April 4, 2013
Results First Submitted Date  ICMJE January 20, 2017
Results First Posted Date  ICMJE March 10, 2017
Last Update Posted Date April 12, 2018
Study Start Date  ICMJE March 2013
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 20, 2017)
Objective Response Rate (ORR) [ Time Frame: 9 weeks (3 cycles) ]
Response assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Original Primary Outcome Measures  ICMJE
 (submitted: March 29, 2013)
Objective response rate assessed using RECIST version 1.1criteria [ Time Frame: 9 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 20, 2017)
  • Progression-free Survival (PFS) at 1 Year [ Time Frame: 1 year ]
    Proportion of participants with progression-free survival (PFS) at 1 year, as calculated based on Kaplan-Meier estimates.
  • Progression-free Survival (PFS) at 2 Years [ Time Frame: 2 years ]
    Proportion of participants with progression-free survival (PFS) at 2 years, as calculated based on Kaplan-Meier estimates.
  • Overall Survival (OS) at 1 Year [ Time Frame: 1 year ]
    Proportion of participants with overall survival (OS) at 1 year, as calculated based on Kaplan-Meier estimates.
  • Overall Survival (OS) at 2 Years [ Time Frame: 2 years ]
    Proportion of participants with overall survival (OS) at 2 years, as calculated based on Kaplan-Meier estimates.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 29, 2013)
  • Incidence of grade 3 or greater adverse events assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: Up to 2 years ]
    Adverse events will be collected according the study calendar and tabulated for cumulative evaluation.
  • Progression free survival (PFS) [ Time Frame: 1 year ]
    Kaplan-Meier estimates of overall and progression-free survival rates will be calculated, along with their corresponding 95% confidence intervals.
  • PFS [ Time Frame: 2 years ]
    Kaplan-Meier estimates of overall and progression-free survival rates will be calculated, along with their corresponding 95% confidence intervals.
  • Overall survival (OS) [ Time Frame: 1 year ]
    Kaplan-Meier estimates of overall and progression-free survival rates will be calculated, along with their corresponding 95% confidence intervals.
  • OS [ Time Frame: 2 years ]
    Kaplan-Meier estimates of overall and progression-free survival rates will be calculated, along with their corresponding 95% confidence intervals.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Capecitabine in Treating Patients With Advanced or Recurrent Squamous Cell Carcinoma of the Skin
Official Title  ICMJE A Phase 2 Study of Capecitabine in Patients With Advanced or Recurrent Squamous Cell Carcinoma of the Skin
Brief Summary Phase 2 evaluation of capecitabine in patients with advanced or recurrent squamous cell carcinoma of the skin.
Detailed 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Squamous Cell Carcinoma of the Skin
  • Recurrent Skin Cancer
Intervention  ICMJE Drug: Capecitabine
Given orally
Other Names:
  • CAPE
  • Ro 09-1978/000
  • Xeloda
Study Arms  ICMJE Experimental: Capecitabine 1000 mg/m²

Participants will receive oral capecitabine twice-a-day (BID) as 500 mg/m² doses on days 1 to 14.

Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Intervention: Drug: Capecitabine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 15, 2014)
2
Original Estimated Enrollment  ICMJE
 (submitted: March 29, 2013)
19
Actual Study Completion Date  ICMJE May 2014
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01823679
Other Study ID Numbers  ICMJE IRB-26699
NCI-2013-00710 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
SKIN0016 ( Other Identifier: OnCore )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party A. Dimitrios Colevas, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Alexander Colevas Stanford University
PRS Account Stanford University
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP