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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

Study Description
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Brief Summary:
Phase 2 evaluation of capecitabine in patients with advanced or recurrent squamous cell carcinoma of the skin.

Condition or disease Intervention/treatment Phase
Squamous Cell Carcinoma of the Skin Recurrent Skin Cancer Drug: Capecitabine Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Capecitabine in Patients With Advanced or Recurrent Squamous Cell Carcinoma of the Skin
Study Start Date : March 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.

 Drug: Capecitabine
Given orally
Other Names:
  • CAPE
  • Ro 09-1978/000
  • Xeloda


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01823679


Locations
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United States, California
Stanford University Hospitals and Clinics
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Alexander Colevas Stanford University
More Information
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Responsible Party: A. Dimitrios Colevas, Associate Professor of Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT01823679    
Other Study ID Numbers: IRB-26699
NCI-2013-00710 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
SKIN0016 ( Other Identifier: OnCore )
First Posted: April 4, 2013    Key Record Dates
Results First Posted: March 10, 2017
Last Update Posted: April 12, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Skin Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
 Neoplasms by Site
Skin Diseases
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents