S1013: Validation of Cancer Questionnaire for Skin Toxicities in Patients With Colorectal Cancer … (NCT01416688) | Clinical Trial Compass
CompletedNot Applicable
S1013: Validation of Cancer Questionnaire for Skin Toxicities in Patients With Colorectal Cancer or Lung Cancer Receiving Cetuximab, Panitumumab, or Erlotinib Hydrochloride
United States146 participantsStarted 2011-11-15
Plain-language 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.
Who can participate
Age range18 Years – 120 Years
SexALL
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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 complet…