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

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.

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