Status:
COMPLETED
S1013: Validation of Cancer Questionnaire for Skin Toxicities in Patients With Colorectal Cancer or Lung Cancer Receiving Cetuximab, Panitumumab, or Erlotinib Hydrochloride
Lead Sponsor:
SWOG Cancer Research Network
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Colorectal Cancer
Dermatologic Complications
Eligibility:
All Genders
18-120 years
Brief 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 hydrochl...
Detailed Description
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 valid...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 15 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 8 2019
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT01416688
Start Date
November 15 2011
End Date
April 8 2019
Last Update
December 15 2022
Active Locations (113)
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1
University of Arizona Cancer Center-North Campus
Tucson, Arizona, United States, 85719
2
The University of Arizona Medical Center-University Campus
Tucson, Arizona, United States, 85724
3
East Bay Radiation Oncology Center
Castro Valley, California, United States, 94546
4
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010