Lung Cancer Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

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 (Efudexâ„¢, Fluoroplexâ„¢, Caracâ„¢)
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-Aâ„¢, Tretinoinâ„¢); or oral retinoids (Amnesteemâ„¢, Claravisâ„¢, Sotretâ„¢)
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 is for people with:

Lung Cancer

Estimated Enrollment:

146

Study ID:

NCT01416688

Recruitment Status:

Completed

Sponsor:

Southwest Oncology Group

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There are 93 Locations for this study

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

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Estimated Enrollment:

146

Study ID:

NCT01416688

Recruitment Status:

Completed

Sponsor:


Southwest Oncology Group

How clear is this clinincal trial information?

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