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

Study 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.

Ask AI to explain this study

Start here

Key things to know

Main goalNot specified

This describes the study’s primary purpose.

What is being studiedassessment of therapy complications and psychosocial assessment and care

Plus 1 other study approaches.

Who it may be forColorectal Cancer · Dermatologic Complications

These are broad labels—not an eligibility decision.

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

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Observational

Where is it offered?113 U.S. locations

Locations may change over time.

Who runs it?SWOG Cancer Research Network

Study sponsor

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

Explore related studies

How this study is categorized

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

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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 (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.

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.

View original record ↗