CompletedNot applicableNCT01416688

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

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.

Checked against the public recordLast updated Dec 15, 2022 · Source: ClinicalTrials.gov

StatusCompleted
PhaseNot applicable
U.S. locations113
SponsorSWOG Cancer Research Network
01
Study overview

What this study is about

Purpose
Not specified
Study type
Observational
Phase
Not applicable
Sponsor
SWOG Cancer Research Network
Interventions being studied
Procedure: assessment of therapy complications; Procedure: psychosocial assessment and care; Procedure: quality-of-life assessment
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of Arizona Cancer Center-North CampusTucson, Arizona
  • The University of Arizona Medical Center-University CampusTucson, Arizona
  • East Bay Radiation Oncology CenterCastro Valley, California
  • City of Hope Comprehensive Cancer CenterDuarte, California
  • Epic Care-DublinDublin, California
  • Bay Area Breast Surgeons IncEmeryville, California
  • Epic Care Partners in Cancer CareEmeryville, California
  • UC San Diego Moores Cancer CenterLa Jolla, California
  • Loma Linda University Medical CenterLoma Linda, California
  • Los Angeles County-USC Medical CenterLos Angeles, California
  • USC / Norris Comprehensive Cancer CenterLos Angeles, California
  • Contra Costa Regional Medical CenterMartinez, California

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 15, 2022. Always confirm current availability with the study team.

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