S1013: Validation of Cancer Questionnaire for Skin Toxicities in Patients With Colorectal Cancer or Lung Cancer Receiving Cetuximab, Panitumumab, or Erlotinib Hydrochloride

S1013: A Prospective Study of Epidermal Growth Factor Receptor (HER-1/EGFR) Inhibitor-Induced Dermatologic Toxicity: Validation of the Functional Assessment of Cancer Therapy-EGFRI 18(FACT-EGFRI 18) Questionnaire for EGFRI-Induced Skin Toxicities

RATIONALE: Questionnaires that patients can use to assess skin toxicities related to treatment may help identify the intermediate-and long-term effects of cetuximab, panitumumab, or erlotinib hydrochloride.

PURPOSE: This trial studies the validation of a cancer questionnaire for skin toxicities in patients with colorectal or lung cancer receiving cetuximab, panitumumab, or erlotinib hydrochloride.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Lung Cancer; Dermatologic Complications; Therapy-related Toxicity
• Intervention / Treatment: Procedure: assessment of therapy complications; Procedure: psychosocial assessment and care; Procedure: quality-of-life assessment

Detailed Description

OBJECTIVES:

Primary

• To establish psychometric properties for the Functional Assessment of Cancer Therapy Epidermal Growth Factor Receptor Inhibitor (FACT-EGFRI 18) module (based on criterion validity, known group's validity, internal consistency reliability, and responsiveness to change) as a patient-reported outcome (PRO) measure of EGFRI-induced skin-related toxicity.

Secondary

• To document minimally important differences over time for the FACT-EGFRI 18 by comparing mean changes in this PRO measure to the patient's direct assessment of change using two anchor items (change in skin condition severity and impact).
• To examine the association between toxicity profiles (severity and time to onset), and treatment profiles (e.g., delays and discontinuation) and the FACT-EGFRI 18 scores.
• To assess degree of concordance between FACT-EGFRI 18 ratings and study site physician CTCAE Version 4.0 EGFRI-Induced Dermatologic Toxicity Grading Assessment ratings.
• To evaluate feasibility outcomes.

OUTLINE: This is a multicenter study.

Patients complete the S1013 Functional Assessment of Cancer Therapy Epidermal Growth Factor Receptor Inhibitor (FACT-EGFRI 18) at baseline and prior to beginning therapy and clinical assessment. Patients also complete FACT-EGFRI 18 and the Changes in Skin Symptoms on days 1*, 8**, 15, 22, 29, 36, 43, 71, 99, and 127. Patients who do not develop any grade of papulopustular rash within 42 days are removed from study.

Investigators performing the patients' clinical assessment complete the EGFRI-Induced Dermatologic Toxicity Grading Assessment on days 1, 8, 15, 22, 29, 36, 43, 71, 99, and 127, and the Treatment Form assessment on days 22, 43, 71, 99, and 127. Nurses or clinical trial administrators (CRA) also complete the S1013 Cover Sheet for Patient Complete Questionnaires accompanying the FACT-EGFRI 18 patients' questionnaires at each schedule assessment.

NOTE: *Patients start EGFRI therapy.

NOTE: **Change in Skin Symptoms questionnaire starts on Day 8.

• Study Type: Observational
• Enrollment (Actual): 146

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85719
      • University of Arizona Cancer Center-North Campus
    • Tucson, Arizona, United States, 85724
      • The University of Arizona Medical Center-University Campus
  • California
    • Castro Valley, California, United States, 94546
      • East Bay Radiation Oncology Center
    • Duarte, California, United States, 91010
      • City of Hope Comprehensive Cancer Center
    • Dublin, California, United States, 94568
      • Epic Care-Dublin
    • Emeryville, California, United States, 94608
      • Bay Area Breast Surgeons Inc
    • Emeryville, California, United States, 94608
      • Epic Care Partners in Cancer Care
    • La Jolla, California, United States, 92093
      • UC San Diego Moores Cancer Center
    • Loma Linda, California, United States, 92354
      • Loma Linda University Medical Center
    • Los Angeles, California, United States, 90033
      • USC / Norris Comprehensive Cancer Center
    • Los Angeles, California, United States, 90033
      • Los Angeles County-USC Medical Center
    • Martinez, California, United States, 94553-3156
      • Contra Costa Regional Medical Center
    • Mountain View, California, United States, 94040
      • El Camino Hospital
    • Oakland, California, United States, 94609
      • Alta Bates Summit Medical Center - Summit Campus
    • Oakland, California, United States, 94609
      • Hematology and Oncology Associates-Oakland
    • Oakland, California, United States, 94602
      • Highland General Hospital
    • Oakland, California, United States, 94609
      • Bay Area Tumor Institute
    • San Pablo, California, United States, 94806
      • Doctors Medical Center- JC Robinson Regional Cancer Center
  • Illinois
    • Bloomington, Illinois, United States, 61704
      • Illinois CancerCare-Bloomington
    • Bloomington, Illinois, United States, 61701
      • Saint Joseph Medical Center
    • Canton, Illinois, United States, 61520
      • Illinois CancerCare-Canton
    • Carbondale, Illinois, United States, 62902
      • Memorial Hospital of Carbondale
    • Carthage, Illinois, United States, 62321
      • Illinois CancerCare-Carthage
    • Centralia, Illinois, United States, 62801
      • Centralia Oncology Clinic
    • Decatur, Illinois, United States, 62526
      • Decatur Memorial Hospital
    • Decatur, Illinois, United States, 62526
      • Heartland Cancer Research NCORP
    • Decatur, Illinois, United States, 62526
      • Cancer Care Center of Decatur
    • Effingham, Illinois, United States, 62401
      • Crossroads Cancer Center
    • Eureka, Illinois, United States, 61530
      • Illinois CancerCare-Eureka
    • Evergreen Park, Illinois, United States, 60805
      • Little Company of Mary Hospital
    • Galesburg, Illinois, United States, 61401
      • Western Illinois Cancer Treatment Center
    • Galesburg, Illinois, United States, 61401
      • Illinois CancerCare-Galesburg
    • Kewanee, Illinois, United States, 61443
      • Illinois CancerCare-Kewanee Clinic
    • Macomb, Illinois, United States, 61455
      • Illinois CancerCare-Macomb
    • Ottawa, Illinois, United States, 61350
      • Illinois CancerCare-Ottawa Clinic
    • Ottawa, Illinois, United States, 61350
      • Radiation Oncology of Northern Illinois
    • Pekin, Illinois, United States, 61554
      • Illinois CancerCare-Pekin
    • Pekin, Illinois, United States, 61554
      • OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
    • Peoria, Illinois, United States, 61637
      • OSF Saint Francis Medical Center
    • Peoria, Illinois, United States, 61615
      • Illinois CancerCare-Peoria
    • Peoria, Illinois, United States, 61615
      • OSF Saint Francis Radiation Oncology at Peoria Cancer Center
    • Peoria, Illinois, United States, 61603
      • Methodist Medical Center of Illinois
    • Peru, Illinois, United States, 61354
      • Illinois CancerCare-Peru
    • Peru, Illinois, United States, 61354
      • Valley Radiation Oncology
    • Princeton, Illinois, United States, 61356
      • Illinois CancerCare-Princeton
    • Springfield, Illinois, United States, 62781
      • Memorial Medical Center
    • Springfield, Illinois, United States, 62702
      • Southern Illinois University School of Medicine
    • Springfield, Illinois, United States, 62702
      • Central Illinois Hematology Oncology Center
    • Springfield, Illinois, United States, 62703
      • Springfield Clinic
    • Swansea, Illinois, United States, 62226
      • Cancer Care Specialists of Illinois-Swansea
  • Kansas
    • Chanute, Kansas, United States, 66720
      • Cancer Center of Kansas - Chanute
    • Dodge City, Kansas, United States, 67801
      • Cancer Center of Kansas - Dodge City
    • El Dorado, Kansas, United States, 67042
      • Cancer Center of Kansas - El Dorado
    • Fort Scott, Kansas, United States, 66701
      • Cancer Center of Kansas - Fort Scott
    • Independence, Kansas, United States, 67301
      • Cancer Center of Kansas-Independence
    • Kingman, Kansas, United States, 67068
      • Cancer Center of Kansas-Kingman
    • Lawrence, Kansas, United States, 66044
      • Lawrence Memorial Hospital
    • Liberal, Kansas, United States, 67905
      • Cancer Center of Kansas-Liberal
    • Manhattan, Kansas, United States, 66502
      • Cancer Center of Kansas-Manhattan
    • McPherson, Kansas, United States, 67460
      • Cancer Center of Kansas - McPherson
    • Newton, Kansas, United States, 67114
      • Cancer Center of Kansas - Newton
    • Overland Park, Kansas, United States, 66209
      • Menorah Medical Center
    • Overland Park, Kansas, United States, 66213
      • Saint Luke's South Hospital
    • Parsons, Kansas, United States, 67357
      • Cancer Center of Kansas - Parsons
    • Pratt, Kansas, United States, 67124
      • Cancer Center of Kansas - Pratt
    • Salina, Kansas, United States, 67401
      • Cancer Center of Kansas - Salina
    • Wellington, Kansas, United States, 67152
      • Cancer Center of Kansas - Wellington
    • Wichita, Kansas, United States, 67208
      • Cancer Center of Kansas-Wichita Medical Arts Tower
    • Wichita, Kansas, United States, 67214
      • Cancer Center of Kansas - Wichita
    • Wichita, Kansas, United States, 67208
      • Associates In Womens Health
    • Wichita, Kansas, United States, 67214
      • Wichita NCI Community Oncology Research Program
    • Wichita, Kansas, United States, 67214
      • Via Christi Regional Medical Center
    • Winfield, Kansas, United States, 67156
      • Cancer Center of Kansas - Winfield
  • Louisiana
    • Monroe, Louisiana, United States, 71202
      • University Health-Conway
    • Shreveport, Louisiana, United States, 71103
      • Louisiana State University Health Sciences Center Shreveport
  • Michigan
    • Flint, Michigan, United States, 48532
      • McLaren Cancer Institute-Flint
    • Flint, Michigan, United States, 48532
      • Singh and Arora Hematology Oncology PC
    • Lapeer, Michigan, United States, 48446
      • McLaren Cancer Institute-Lapeer Region
    • Mount Clemens, Michigan, United States, 48043
      • McLaren Cancer Institute-Macomb
    • Petoskey, Michigan, United States, 49770
      • McLaren Cancer Institute-Northern Michigan
  • Missouri
    • Bonne Terre, Missouri, United States, 63628
      • Parkland Health Center-Bonne Terre
    • Cape Girardeau, Missouri, United States, 63703
      • Saint Francis Medical Center
    • Cape Girardeau, Missouri, United States, 63703
      • Southeast Cancer Center
    • Independence, Missouri, United States, 64057
      • Centerpoint Medical Center LLC
    • Jefferson City, Missouri, United States, 65109
      • Capital Region Medical Center-Goldschmidt Cancer Center
    • Kansas City, Missouri, United States, 64111
      • Saint Luke's Hospital of Kansas City
    • Kansas City, Missouri, United States, 64132
      • Research Medical Center
    • Kansas City, Missouri, United States, 64118
      • Heartland Hematology and Oncology Associates Incorporated
    • Lee's Summit, Missouri, United States, 64086
      • Saint Luke's East - Lee's Summit
    • Liberty, Missouri, United States, 64068
      • Liberty Radiation Oncology Center
    • Saint Joseph, Missouri, United States, 64506
      • Heartland Regional Medical Center
    • Saint Louis, Missouri, United States, 63131
      • Missouri Baptist Medical Center
    • Sainte Genevieve, Missouri, United States, 63670
      • Sainte Genevieve County Memorial Hospital
    • Sullivan, Missouri, United States, 63080
      • Missouri Baptist Sullivan Hospital
    • Sunset Hills, Missouri, United States, 63127
      • Missouri Baptist Outpatient Center-Sunset Hills
  • New York
    • Mineola, New York, United States, 11501
      • Winthrop University Hospital
    • New York, New York, United States, 10032
      • Columbia University/Herbert Irving Cancer Center
  • North Carolina
    • Asheville, North Carolina, United States, 28816
      • Hope Women's Cancer Centers-Asheville
    • Asheville, North Carolina, United States, 28801
      • Cancer Care of Western North Carolina
    • Asheville, North Carolina, United States, 28801
      • Mission Hospital-Memorial Campus
    • Charlotte, North Carolina, United States, 28203
      • Carolinas Medical Center/Levine Cancer Institute
    • Clinton, North Carolina, United States, 28328
      • Southeastern Medical Oncology Center-Clinton
    • Concord, North Carolina, United States, 28025
      • Carolinas HealthCare System NorthEast
    • Goldsboro, North Carolina, United States, 27534
      • Southeastern Medical Oncology Center-Goldsboro
    • Goldsboro, North Carolina, United States, 27534
      • Wayne Memorial Hospital
    • Hendersonville, North Carolina, United States, 28791
      • Hendersonville Hematology and Oncology at Pardee
    • Hendersonville, North Carolina, United States, 28791
      • Margaret R Pardee Memorial Hospital
    • High Point, North Carolina, United States, 27261
      • High Point Regional Hospital
    • Jacksonville, North Carolina, United States, 28546
      • Southeastern Medical Oncology Center-Jacksonville
    • Monroe, North Carolina, United States, 28112
      • Carolinas HealthCare System Union
    • Shelby, North Carolina, United States, 28150
      • Carolinas HealthCare System Cleveland
    • Wilson, North Carolina, United States, 27893
      • Southeastern Medical Oncology Center-Wilson
    • Winston-Salem, North Carolina, United States, 27104
      • Southeast Clinical Oncology Research (SCOR) Consortium NCORP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 118 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Limited institutions from the SWOG membership.

Description

DISEASE CHARACTERISTICS:

• Patients must have a diagnosis of colorectal or lung cancer and be planning to receive one of the following epidermal growth factor receptor (HER1/EGFR) inhibitor therapies listed below for at least 6 weeks:

  • Cetuximab 400 mg/m² loading dose, 250 mg/m² weekly
  • Cetuximab 500 mg/m² every 2 weeks
  • Panitumumab 6 mg/kg every 2 weeks
  • Erlotinib hydrochloride 100-150 mg daily
  • Other HER1/EGFR inhibitor therapies, schedules, or doses of the above listed agents are not allowed
  • Concurrent chemotherapy and other anti-cancer therapies (such as carboplatin, paclitaxel, and bevacizumab) are allowed EXCEPT for the following chemotherapeutic agents that are known to cause skin rash that could interfere with EGFRI-induced skin toxicity assessment: gemcitabine, capecitabine, and topical fluorouracil (Efudex™, Fluoroplex™, Carac™)
• Patients must have completed the baseline S1013 Functional Assessment of Cancer Therapy- (FACT) EGFRI 18 within 7 days prior to registration

PATIENT CHARACTERISTICS:

• Patients must have a Zubrod performance status of 0-2
• Patients must not have any of the following serious concomitant skin disorders that, in the investigator's opinion, could interfere with assessment of epidermal growth factor receptor inhibitor (EGFRI)-induced skin toxicity: atopic dermatitis [eczema]; contact dermatitis; psoriasis; rosacea; severe photosensitivity; scleroderma; steroid-induced acne; or xerosis
• Patients must be able to complete questionnaires in English

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• Patients may have had prior epidermal growth factor receptor (HER1/EGFR) inhibitor therapy but must have fully recovered from any skin toxicities prior to registration
• Patients must not be planning to receive any of the following concomitant medications that can cause skin rash or other dermatologic reactions that could interfere with the EGFRI-induced skin toxicity assessments, for the duration of the study: allopurinol; systemic corticosteroids; topical retinoids (Retin-A™, Tretinoin™); or oral retinoids (Amnesteem™, Claravis™, Sotret™)
• Patients must not be planning to receive concurrent external-beam radiation therapy, including prophylactic cranial radiation
• Patients may concurrently participate in other therapeutic clinical trials

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observation and Questionnaires; Patients will be given questionnaires for the assessment of therapy complications, psychosocial assessment and care, and quality-of-life assessment.	Procedure: assessment of therapy complications; Will be given by questionnaire; Procedure: psychosocial assessment and care; Will be given by questionnaire; Procedure: quality-of-life assessment; Will be given by questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Psychometric properties of the FACT-EGFRI 18	127 days from registration

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in severity and impact of skin symptoms	127 days from registration
Agreement between site physician ratings with the CTCAE Version 4 and patient ratings for the FACT-EGFRI 18 items	127 days from registration
Associations between toxicity profile and treatment profiles	127 days from registration
Feasibility as measured by accrual, time to specified accrual, time to complete forms	2 years from study activation

Collaborators and Investigators

• Sponsor: Southwest Oncology Group
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2011
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): April 8, 2019

Study Registration Dates

• First Submitted: August 12, 2011
• First Submitted That Met QC Criteria: August 12, 2011
• First Posted (Estimate): August 15, 2011

Study Record Updates

• Last Update Posted (Estimate): December 15, 2022
• Last Update Submitted That Met QC Criteria: December 14, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: recurrent non-small cell lung cancer; extensive stage small cell lung cancer; recurrent small cell lung cancer; stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; recurrent colon cancer; recurrent rectal cancer; limited stage small cell lung cancer; stage IIIB rectal cancer; stage IIIC rectal cancer; stage IA non-small cell lung cancer; stage IB non-small cell lung cancer; stage I rectal cancer; stage IIA non-small cell lung cancer; stage IIB non-small cell lung cancer; stage I colon cancer; stage IIA colon cancer; stage IIB colon cancer; stage IIC colon cancer; stage IIIA colon cancer; stage IIA rectal cancer; stage IIB rectal cancer; stage IIC rectal cancer; stage IIIA rectal cancer; therapy-related toxicity; stage IIIB colon cancer; stage IIIC colon cancer; stage IVA colon cancer; stage IVB colon cancer; stage IVA rectal cancer; stage IVB rectal cancer; dermatologic complications
• Additional Relevant MeSH Terms: Digestive System Diseases; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Lung Neoplasms; Colorectal Neoplasms
• Other Study ID Numbers: S1013 (Other Identifier: SWOG); U10CA037429 (U.S. NIH Grant/Contract); NCI-2011-02983 (Other Identifier: NCI)