Clinical trial · Observational

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

S1013: A Prospective Study of Epidermal Growth Factor Receptor (HER-1/EGFR) Inhibitor-Induced Dermatologic Toxicity: Validation of the Functional Assessment of Cancer Therapy-EGFRI 18(FACT-EGFRI 18) Questionnaire for EGFRI-Induced Skin Toxicities

NCT01416688CI-TRIAL-00062715completedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (4)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Colorectal Cancer	Malignant Colorectal Neoplasm	CURATED_BROADER	0.80
Dermatologic Complications	—	UNRESOLVED	—
Lung Cancer	Malignant Lung Neoplasm	CURATED_EXACT	0.92
Therapy-related Toxicity	—	UNRESOLVED	—

Interventions

Interventions (3)

Intervention	Type	Mapped drug	Match
assessment of therapy complications	Procedure	—	UNRESOLVED
psychosocial assessment and care	Procedure	—	UNRESOLVED
quality-of-life assessment	Procedure	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

label
Observation and Questionnaires
description
Patients will be given questionnaires for the assessment of therapy complications, psychosocial assessment and care, and quality-of-life assessment.
interventionNames
1. Procedure: assessment of therapy complications
2. Procedure: psychosocial assessment and care
3. Procedure: quality-of-life assessment

Primary outcomes (1)

measure
Psychometric properties of the FACT-EGFRI 18
timeFrame
127 days from registration

Secondary outcomes (4)

measure
Change in severity and impact of skin symptoms
timeFrame
127 days from registration
measure

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 120 Years

Show eligibility criteria text

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

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment

Start: Nov 15, 2011
Primary completion: May 1, 2018
Completion: Apr 8, 2019
First posted: Aug 15, 2011
Last update posted: Dec 15, 2022
Enrollment: 146 (actual)
Lead sponsor: SWOG Cancer Research Network NETWORK
Collaborators: National Cancer Institute (NCI)
Keywords: therapy-related toxicity, dermatologic complications, stage I colon cancer, stage IIA colon cancer, stage IIB colon cancer, stage IIC colon cancer, stage IIIA colon cancer, stage IIIB colon cancer, stage IIIC colon cancer, stage IVA colon cancer, stage IVB colon cancer, stage I rectal cancer, stage IIA rectal cancer, stage IIB rectal cancer, stage IIC rectal cancer, stage IIIA rectal cancer, stage IIIB rectal cancer, stage IIIC rectal cancer, stage IVA rectal cancer, stage IVB rectal cancer, stage IA non-small cell lung cancer, stage IB non-small cell lung cancer, stage IIA non-small cell lung cancer, stage IIB non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, extensive stage small cell lung cancer, limited stage small cell lung cancer, recurrent small cell lung cancer, recurrent colon cancer, recurrent rectal cancer, recurrent non-small cell lung cancer