Know Cancer

or
forgot password

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


N/A
N/A
N/A
Open (Enrolling)
Both
Colorectal Cancer, Dermatologic Complications, Lung Cancer, Therapy-related Toxicity

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Outcome Measure:

Psychometric properties of the FACT-EGFRI 18

Outcome Time Frame:

127 days from registration

Safety Issue:

No

Principal Investigator

Laurence H. Baker, DO, FACOI

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000708371

NCT ID:

NCT01416688

Start Date:

November 2011

Completion Date:

September 2014

Related Keywords:

  • Colorectal Cancer
  • Dermatologic Complications
  • Lung Cancer
  • Therapy-related Toxicity
  • 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
  • Colorectal Neoplasms
  • Lung Neoplasms

Name

Location

CCOP - WichitaWichita, Kansas  67214-3882
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
City of Hope Comprehensive Cancer CenterDuarte, California  91010
Blumenthal Cancer Center at Carolinas Medical CenterCharlotte, North Carolina  28232-2861
Winthrop University HospitalMineola, New York  11501
Loma Linda University Cancer Institute at Loma Linda University Medical CenterLoma Linda, California  92354
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
Mission Hospitals - Memorial CampusAsheville, North Carolina  28801
Presbyterian Cancer Center at Presbyterian HospitalCharlotte, North Carolina  28233-3549
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
Decatur Memorial Hospital Cancer Care InstituteDecatur, Illinois  62526
Cancer Center of Kansas, PA - Dodge CityDodge City, Kansas  67801
Cancer Center of Kansas, PA - ChanuteChanute, Kansas  66720
Cancer Center of Kansas - Fort ScottFort Scott, Kansas  66701
Cancer Center of Kansas-IndependenceIndependence, Kansas  67301
Cancer Center of Kansas, PA - KingmanKingman, Kansas  67068
Lawrence Memorial HospitalLawrence, Kansas  66044
Cancer Center of Kansas, PA - LiberalLiberal, Kansas  67905
Cancer Center of Kansas, PA - NewtonNewton, Kansas  67114
Cancer Center of Kansas, PA - ParsonsParsons, Kansas  67357
Cancer Center of Kansas, PA - PrattPratt, Kansas  67124
Cancer Center of Kansas, PA - SalinaSalina, Kansas  67401
Cancer Center of Kansas, PA - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, PA - WichitaWichita, Kansas  67214
Associates in Womens Health, PA - North ReviewWichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas, PA - WinfieldWinfield, Kansas  67156
Pardee Memorial HospitalHendersonville, North Carolina  28791
High Point Regional HospitalHigh Point, North Carolina  27261