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

NCT01823679 | Terminated Phase 2 Results DMC

• 3 other identifiers: IRB-26699NCI-2013-00710SKIN0016
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Squamous Cell Carcinoma of the Skin; Recurrent Skin Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  Response assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

  9 weeks (3 cycles)

Secondary Outcomes (4)

• Progression-free Survival (PFS) at 1 Year

  1 year

• Progression-free Survival (PFS) at 2 Years

  2 years

• Overall Survival (OS) at 1 Year

  1 year

• Overall Survival (OS) at 2 Years

  2 years

Study Arms (1)

Capecitabine 1000 mg/m²

EXPERIMENTAL

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

Interventions

Capecitabine DRUG

Given orally

Also known as: CAPE, Ro 09-1978/000, Xeloda

Capecitabine 1000 mg/m²

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Stanford University Hospitals and Clinics

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Skin Neoplasms

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Alexander Dimitrios Colevas, MD
• Organization: Stanford University Medical Center

colevas@stanford.edu

650-724-9707

Study Officials

• Alexander Colevas

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: March 29, 2013
• First Posted: April 4, 2013
• Study Start: March 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: April 12, 2018
• Results First Posted: March 10, 2017

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)