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.
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.
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
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There are 93 Locations for this study
Tucson Arizona, 85719, United States
Tucson Arizona, 85724, United States
Castro Valley California, 94546, United States
Duarte California, 91010, United States
Dublin California, 94568, United States
Emeryville California, 94608, United States
Emeryville California, 94608, United States
La Jolla California, 92093, United States
Loma Linda California, 92354, United States
Los Angeles California, 90033, United States
Los Angeles California, 90033, United States
Martinez California, 94553, United States
Mountain View California, 94040, United States
Oakland California, 94602, United States
Oakland California, 94609, United States
Oakland California, 94609, United States
Oakland California, 94609, United States
San Pablo California, 94806, United States
Bloomington Illinois, 61701, United States
Bloomington Illinois, 61704, United States
Canton Illinois, 61520, United States
Carbondale Illinois, 62902, United States
Carthage Illinois, 62321, United States
Centralia Illinois, 62801, United States
Decatur Illinois, 62526, United States
Decatur Illinois, 62526, United States
Decatur Illinois, 62526, United States
Effingham Illinois, 62401, United States
Eureka Illinois, 61530, United States
Evergreen Park Illinois, 60805, United States
Galesburg Illinois, 61401, United States
Galesburg Illinois, 61401, United States
Kewanee Illinois, 61443, United States
Macomb Illinois, 61455, United States
Ottawa Illinois, 61350, United States
Ottawa Illinois, 61350, United States
Pekin Illinois, 61554, United States
Pekin Illinois, 61554, United States
Peoria Illinois, 61603, United States
Peoria Illinois, 61615, United States
Peoria Illinois, 61615, United States
Peoria Illinois, 61637, United States
Peru Illinois, 61354, United States
Peru Illinois, 61354, United States
Princeton Illinois, 61356, United States
Springfield Illinois, 62702, United States
Springfield Illinois, 62702, United States
Springfield Illinois, 62703, United States
Springfield Illinois, 62781, United States
Swansea Illinois, 62226, United States
Chanute Kansas, 66720, United States
Dodge City Kansas, 67801, United States
El Dorado Kansas, 67042, United States
Fort Scott Kansas, 66701, United States
Independence Kansas, 67301, United States
Kingman Kansas, 67068, United States
Lawrence Kansas, 66044, United States
Liberal Kansas, 67905, United States
Manhattan Kansas, 66502, United States
McPherson Kansas, 67460, United States
Newton Kansas, 67114, United States
Overland Park Kansas, 66209, United States
Overland Park Kansas, 66213, United States
Parsons Kansas, 67357, United States
Pratt Kansas, 67124, United States
Salina Kansas, 67401, United States
Wellington Kansas, 67152, United States
Wichita Kansas, 67208, United States
Wichita Kansas, 67208, United States
Wichita Kansas, 67214, United States
Wichita Kansas, 67214, United States
Wichita Kansas, 67214, United States
Winfield Kansas, 67156, United States
Monroe Louisiana, 71202, United States
Shreveport Louisiana, 71103, United States
Flint Michigan, 48532, United States
Flint Michigan, 48532, United States
Lapeer Michigan, 48446, United States
Mount Clemens Michigan, 48043, United States
Petoskey Michigan, 49770, United States
Bonne Terre Missouri, 63628, United States
Cape Girardeau Missouri, 63703, United States
Cape Girardeau Missouri, 63703, United States
Independence Missouri, 64057, United States
Jefferson City Missouri, 65109, United States
Kansas City Missouri, 64111, United States
Kansas City Missouri, 64118, United States
Kansas City Missouri, 64132, United States
Lee's Summit Missouri, 64086, United States
Liberty Missouri, 64068, United States
Saint Joseph Missouri, 64506, United States
Saint Louis Missouri, 63131, United States
Sainte Genevieve Missouri, 63670, United States
Sullivan Missouri, 63080, United States
Sunset Hills Missouri, 63127, United States
Mineola New York, 11501, United States
New York New York, 10032, United States
Asheville North Carolina, 28801, United States
Asheville North Carolina, 28801, United States
Asheville North Carolina, 28816, United States
Charlotte North Carolina, 28203, United States
Clinton North Carolina, 28328, United States
Concord North Carolina, 28025, United States
Goldsboro North Carolina, 27534, United States
Goldsboro North Carolina, 27534, United States
Hendersonville North Carolina, 28791, United States
Hendersonville North Carolina, 28791, United States
High Point North Carolina, 27261, United States
Jacksonville North Carolina, 28546, United States
Monroe North Carolina, 28112, United States
Shelby North Carolina, 28150, United States
Wilson North Carolina, 27893, United States
Winston-Salem North Carolina, 27104, United States
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