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

NCT01416688 | Completed DMC

• 3 other identifiers: S1013U10CA037429NCI-2011-02983
• Study Type: observational
• Target: 146
• Locations: 1 country
• Sites: 113

Brief Summary

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.

Conditions

Colorectal Cancer; Dermatologic Complications; Lung Cancer; Therapy-related Toxicity

Keywords

therapy-related toxicity; dermatologic complications; stage I colon cancer; stage IIA colon cancer; stage IIB colon cancer; stage IIC colon cancer; stage IIIA colon cancer; stage IIIB colon cancer; stage IIIC colon cancer; stage IVA colon cancer; stage IVB colon cancer; stage I rectal cancer; stage IIA rectal cancer; stage IIB rectal cancer; stage IIC rectal cancer; stage IIIA rectal cancer; stage IIIB rectal cancer; stage IIIC rectal cancer; stage IVA rectal cancer; stage IVB rectal cancer; stage IA non-small cell lung cancer; stage IB non-small cell lung cancer; stage IIA non-small cell lung cancer; stage IIB non-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; extensive stage small cell lung cancer; limited stage small cell lung cancer; recurrent small cell lung cancer; recurrent colon cancer; recurrent rectal cancer; recurrent non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Psychometric properties of the FACT-EGFRI 18

  127 days from registration

Secondary Outcomes (4)

• 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

Study Arms (1)

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; Procedure: psychosocial assessment and care; Procedure: quality-of-life assessment

Interventions

assessment of therapy complications PROCEDURE

Will be given by questionnaire

Observation and Questionnaires

psychosocial assessment and care PROCEDURE

Will be given by questionnaire

Observation and Questionnaires

quality-of-life assessment PROCEDURE

Will be given by questionnaire

Observation and Questionnaires

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Limited institutions from the SWOG membership.

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• SWOG Cancer Research Network: lead
• National Cancer Institute (NCI): collaborator

Study Sites (113)

University of Arizona Cancer Center-North Campus

Tucson, Arizona, 85719, United States

Location

The University of Arizona Medical Center-University Campus

Tucson, Arizona, 85724, United States

Location

East Bay Radiation Oncology Center

Castro Valley, California, 94546, United States

Location

City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States

Location

Epic Care-Dublin

Dublin, California, 94568, United States

Location

Bay Area Breast Surgeons Inc

Emeryville, California, 94608, United States

Location

Epic Care Partners in Cancer Care

Emeryville, California, 94608, United States

Location

UC San Diego Moores Cancer Center

La Jolla, California, 92093, United States

Location

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

Los Angeles County-USC Medical Center

Los Angeles, California, 90033, United States

Location

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Contra Costa Regional Medical Center

Martinez, California, 94553-3156, United States

Location

El Camino Hospital

Mountain View, California, 94040, United States

Location

Highland General Hospital

Oakland, California, 94602, United States

Location

Alta Bates Summit Medical Center - Summit Campus

Oakland, California, 94609, United States

Location

Bay Area Tumor Institute

Oakland, California, 94609, United States

Location

Hematology and Oncology Associates-Oakland

Oakland, California, 94609, United States

Location

Doctors Medical Center- JC Robinson Regional Cancer Center

San Pablo, California, 94806, United States

Location

Saint Joseph Medical Center

Bloomington, Illinois, 61701, United States

Location

Illinois CancerCare-Bloomington

Bloomington, Illinois, 61704, United States

Location

Illinois CancerCare-Canton

Canton, Illinois, 61520, United States

Location

Memorial Hospital of Carbondale

Carbondale, Illinois, 62902, United States

Location

Illinois CancerCare-Carthage

Carthage, Illinois, 62321, United States

Location

Centralia Oncology Clinic

Centralia, Illinois, 62801, United States

Location

Cancer Care Center of Decatur

Decatur, Illinois, 62526, United States

Location

Decatur Memorial Hospital

Decatur, Illinois, 62526, United States

Location

Heartland Cancer Research NCORP

Decatur, Illinois, 62526, United States

Location

Crossroads Cancer Center

Effingham, Illinois, 62401, United States

Location

Illinois CancerCare-Eureka

Eureka, Illinois, 61530, United States

Location

Little Company of Mary Hospital

Evergreen Park, Illinois, 60805, United States

Location

Illinois CancerCare-Galesburg

Galesburg, Illinois, 61401, United States

Location

Western Illinois Cancer Treatment Center

Galesburg, Illinois, 61401, United States

Location

Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, 61443, United States

Location

Illinois CancerCare-Macomb

Macomb, Illinois, 61455, United States

Location

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, 61350, United States

Location

Radiation Oncology of Northern Illinois

Ottawa, Illinois, 61350, United States

Location

Illinois CancerCare-Pekin

Pekin, Illinois, 61554, United States

Location

OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center

Pekin, Illinois, 61554, United States

Location

Methodist Medical Center of Illinois

Peoria, Illinois, 61603, United States

Location

Illinois CancerCare-Peoria

Peoria, Illinois, 61615, United States

Location

OSF Saint Francis Radiation Oncology at Peoria Cancer Center

Peoria, Illinois, 61615, United States

Location

OSF Saint Francis Medical Center

Peoria, Illinois, 61637, United States

Location

Illinois CancerCare-Peru

Peru, Illinois, 61354, United States

Location

Valley Radiation Oncology

Peru, Illinois, 61354, United States

Location

Illinois CancerCare-Princeton

Princeton, Illinois, 61356, United States

Location

Central Illinois Hematology Oncology Center

Springfield, Illinois, 62702, United States

Location

Southern Illinois University School of Medicine

Springfield, Illinois, 62702, United States

Location

Springfield Clinic

Springfield, Illinois, 62703, United States

Location

Memorial Medical Center

Springfield, Illinois, 62781, United States

Location

Cancer Care Specialists of Illinois-Swansea

Swansea, Illinois, 62226, United States

Location

Cancer Center of Kansas - Chanute

Chanute, Kansas, 66720, United States

Location

Cancer Center of Kansas - Dodge City

Dodge City, Kansas, 67801, United States

Location

Cancer Center of Kansas - El Dorado

El Dorado, Kansas, 67042, United States

Location

Cancer Center of Kansas - Fort Scott

Fort Scott, Kansas, 66701, United States

Location

Cancer Center of Kansas-Independence

Independence, Kansas, 67301, United States

Location

Cancer Center of Kansas-Kingman

Kingman, Kansas, 67068, United States

Location

Lawrence Memorial Hospital

Lawrence, Kansas, 66044, United States

Location

Cancer Center of Kansas-Liberal

Liberal, Kansas, 67905, United States

Location

Cancer Center of Kansas-Manhattan

Manhattan, Kansas, 66502, United States

Location

Cancer Center of Kansas - McPherson

McPherson, Kansas, 67460, United States

Location

Cancer Center of Kansas - Newton

Newton, Kansas, 67114, United States

Location

Menorah Medical Center

Overland Park, Kansas, 66209, United States

Location

Saint Luke's South Hospital

Overland Park, Kansas, 66213, United States

Location

Cancer Center of Kansas - Parsons

Parsons, Kansas, 67357, United States

Location

Cancer Center of Kansas - Pratt

Pratt, Kansas, 67124, United States

Location

Cancer Center of Kansas - Salina

Salina, Kansas, 67401, United States

Location

Cancer Center of Kansas - Wellington

Wellington, Kansas, 67152, United States

Location

Associates In Womens Health

Wichita, Kansas, 67208, United States

Location

Cancer Center of Kansas-Wichita Medical Arts Tower

Wichita, Kansas, 67208, United States

Location

Cancer Center of Kansas - Wichita

Wichita, Kansas, 67214, United States

Location

Via Christi Regional Medical Center

Wichita, Kansas, 67214, United States

Location

Wichita NCI Community Oncology Research Program

Wichita, Kansas, 67214, United States

Location

Cancer Center of Kansas - Winfield

Winfield, Kansas, 67156, United States

Location

University Health-Conway

Monroe, Louisiana, 71202, United States

Location

Louisiana State University Health Sciences Center Shreveport

Shreveport, Louisiana, 71103, United States

Location

McLaren Cancer Institute-Flint

Flint, Michigan, 48532, United States

Location

Singh and Arora Hematology Oncology PC

Flint, Michigan, 48532, United States

Location

McLaren Cancer Institute-Lapeer Region

Lapeer, Michigan, 48446, United States

Location

McLaren Cancer Institute-Macomb

Mount Clemens, Michigan, 48043, United States

Location

McLaren Cancer Institute-Northern Michigan

Petoskey, Michigan, 49770, United States

Location

Parkland Health Center-Bonne Terre

Bonne Terre, Missouri, 63628, United States

Location

Saint Francis Medical Center

Cape Girardeau, Missouri, 63703, United States

Location

Southeast Cancer Center

Cape Girardeau, Missouri, 63703, United States

Location

Centerpoint Medical Center LLC

Independence, Missouri, 64057, United States

Location

Capital Region Medical Center-Goldschmidt Cancer Center

Jefferson City, Missouri, 65109, United States

Location

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States

Location

Heartland Hematology and Oncology Associates Incorporated

Kansas City, Missouri, 64118, United States

Location

Research Medical Center

Kansas City, Missouri, 64132, United States

Location

Saint Luke's East - Lee's Summit

Lee's Summit, Missouri, 64086, United States

Location

Liberty Radiation Oncology Center

Liberty, Missouri, 64068, United States

Location

Heartland Regional Medical Center

Saint Joseph, Missouri, 64506, United States

Location

Sainte Genevieve County Memorial Hospital

Sainte Genevieve, Missouri, 63670, United States

Location

Missouri Baptist Medical Center

St Louis, Missouri, 63131, United States

Location

Missouri Baptist Sullivan Hospital

Sullivan, Missouri, 63080, United States

Location

Missouri Baptist Outpatient Center-Sunset Hills

Sunset Hills, Missouri, 63127, United States

Location

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

Columbia University/Herbert Irving Cancer Center

New York, New York, 10032, United States

Location

Cancer Care of Western North Carolina

Asheville, North Carolina, 28801, United States

Location

Mission Hospital-Memorial Campus

Asheville, North Carolina, 28801, United States

Location

Hope Women's Cancer Centers-Asheville

Asheville, North Carolina, 28816, United States

Location

Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina, 28203, United States

Location

Southeastern Medical Oncology Center-Clinton

Clinton, North Carolina, 28328, United States

Location

Carolinas HealthCare System NorthEast

Concord, North Carolina, 28025, United States

Location

Southeastern Medical Oncology Center-Goldsboro

Goldsboro, North Carolina, 27534, United States

Location

Wayne Memorial Hospital

Goldsboro, North Carolina, 27534, United States

Location

Hendersonville Hematology and Oncology at Pardee

Hendersonville, North Carolina, 28791, United States

Location

Margaret R Pardee Memorial Hospital

Hendersonville, North Carolina, 28791, United States

Location

High Point Regional Hospital

High Point, North Carolina, 27261, United States

Location

Southeastern Medical Oncology Center-Jacksonville

Jacksonville, North Carolina, 28546, United States

Location

Carolinas HealthCare System Union

Monroe, North Carolina, 28112, United States

Location

Carolinas HealthCare System Cleveland

Shelby, North Carolina, 28150, United States

Location

Southeastern Medical Oncology Center-Wilson

Wilson, North Carolina, 27893, United States

Location

Southeast Clinical Oncology Research (SCOR) Consortium NCORP

Winston-Salem, North Carolina, 27104, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Lung Neoplasms; Colonic Neoplasms; Rectal Neoplasms; Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma

Interventions

Psychiatric Rehabilitation

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Rehabilitation; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Laurence H. Baker, DO, FACOI

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2011
• First Posted: August 15, 2011
• Study Start: November 15, 2011
• Primary Completion: May 1, 2018
• Study Completion: April 8, 2019
• Last Updated: December 15, 2022

Record last verified: 2022-12

Locations

US (113)