S1013: Validation of Cancer Questionnaire for Skin Toxicities in Patients With Colorectal Cancer or Lung Cancer Receiving Cetuximab, Panitumumab, or Erlotinib Hydrochloride
This study is currently recruiting participants.
Verified January 2013 by Southwest Oncology Group
Sponsor:
Southwest Oncology Group
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT01416688
First received: August 12, 2011
Last updated: January 15, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Colorectal Cancer Dermatologic Complications Lung Cancer Therapy-related Toxicity |
Procedure: assessment of therapy complications Procedure: psychosocial assessment and care Procedure: quality-of-life assessment |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Southwest Oncology Group:
Primary Outcome Measures:
- Psychometric properties of the FACT-EGFRI 18 [ Time Frame: 127 days from registration ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change in severity and impact of skin symptoms [ Time Frame: 127 days from registration ] [ Designated as safety issue: No ]
- Agreement between site physician ratings with the CTCAE Version 4 and patient ratings for the FACT-EGFRI 18 items [ Time Frame: 127 days from registration ] [ Designated as safety issue: No ]
- Associations between toxicity profile and treatment profiles [ Time Frame: 127 days from registration ] [ Designated as safety issue: Yes ]
- Feasibility as measured by accrual, time to specified accrual, time to complete forms [ Time Frame: 2 years from study activation ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 140 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | September 2014 |
| Estimated Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Observation and Questionnaires
Patients will be given questionnaires for the assessment of therapy complications, psychosocial assessment and care, and quality-of-life assessment.
|
Procedure: assessment of therapy complications
Will be given by questionnaire
Procedure: psychosocial assessment and care
Will be given by questionnaire
Procedure: quality-of-life assessment
Will be given by questionnaire
|
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 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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Limited institutions from the SWOG membership.
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01416688
Contacts
| Contact: Kimberly Kaberle | 2106148808 ext 1022 | kkaberle@swog.org |
| Contact: Dana Sparks, MAT | 2106148808 ext 1004 | dsparks@swog.org |
Locations
| United States, California | |
| City of Hope Comprehensive Cancer Center | Recruiting |
| Duarte, California, United States, 91010-3000 | |
| Contact: Clinical Trials Office - City of Hope Comprehensive Cancer Cen 800-826-4673 becomingapatient@coh.org | |
| Loma Linda University Cancer Institute at Loma Linda University Medical Center | Recruiting |
| Loma Linda, California, United States, 92354 | |
| Contact: Clinical Trials Office - Loma Linda University Cancer Institut 909-558-3375 | |
| USC/Norris Comprehensive Cancer Center and Hospital | Recruiting |
| Los Angeles, California, United States, 90089-9181 | |
| Contact: Clinical Trials Office - USC/Norris Comprehensive Cancer Cente 323-865-0451 | |
| United States, Illinois | |
| Decatur Memorial Hospital Cancer Care Institute | Recruiting |
| Decatur, Illinois, United States, 62526 | |
| Contact: Clinical Trials Office - Decatur Memorial Hospital Cancer Care 217-876-4750 | |
| United States, Kansas | |
| Cancer Center of Kansas, PA - Chanute | Recruiting |
| Chanute, Kansas, United States, 66720 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Cancer Center of Kansas, PA - Dodge City | Recruiting |
| Dodge City, Kansas, United States, 67801 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Cancer Center of Kansas - Fort Scott | Recruiting |
| Fort Scott, Kansas, United States, 66701 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Cancer Center of Kansas-Independence | Recruiting |
| Independence, Kansas, United States, 67301 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Cancer Center of Kansas, PA - Kingman | Recruiting |
| Kingman, Kansas, United States, 67068 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Lawrence Memorial Hospital | Recruiting |
| Lawrence, Kansas, United States, 66044 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Cancer Center of Kansas, PA - Liberal | Recruiting |
| Liberal, Kansas, United States, 67901 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Cancer Center of Kansas, PA - Newton | Recruiting |
| Newton, Kansas, United States, 67114 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Cancer Center of Kansas, PA - Parsons | Recruiting |
| Parsons, Kansas, United States, 67357 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Cancer Center of Kansas, PA - Pratt | Recruiting |
| Pratt, Kansas, United States, 67124 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Cancer Center of Kansas, PA - Salina | Recruiting |
| Salina, Kansas, United States, 67401 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Cancer Center of Kansas, PA - Wellington | Recruiting |
| Wellington, Kansas, United States, 67152 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Cancer Center of Kansas, PA - Wichita | Recruiting |
| Wichita, Kansas, United States, 67214 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Cancer Center of Kansas, PA - Medical Arts Tower | Recruiting |
| Wichita, Kansas, United States, 67208 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Via Christi Cancer Center at Via Christi Regional Medical Center | Recruiting |
| Wichita, Kansas, United States, 67214 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| CCOP - Wichita | Recruiting |
| Wichita, Kansas, United States, 67214 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Associates in Womens Health, PA - North Review | Recruiting |
| Wichita, Kansas, United States, 67208 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Cancer Center of Kansas, PA - Winfield | Recruiting |
| Winfield, Kansas, United States, 67156 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| United States, New York | |
| Winthrop University Hospital | Recruiting |
| Mineola, New York, United States, 11501 | |
| Contact: Harry Staszewski, MD 516-663-9500 | |
| United States, North Carolina | |
| Mission Hospitals - Memorial Campus | Recruiting |
| Asheville, North Carolina, United States, 28801 | |
| Contact: Clinical Trials Office - Mission Hospitals - Memorial Campus 828-213-4150 | |
| Blumenthal Cancer Center at Carolinas Medical Center | Recruiting |
| Charlotte, North Carolina, United States, 28232-2861 | |
| Contact: Clinical Trials Office - Blumenthal Cancer Center at Carolinas 704-355-2884 | |
| Presbyterian Cancer Center at Presbyterian Hospital | Recruiting |
| Charlotte, North Carolina, United States, 28233-3549 | |
| Contact: Clinical Trials Office - Presbyterian Cancer Center at Presbyt 704-384-5369 | |
| Wayne Memorial Hospital, Incorporated | Recruiting |
| Goldsboro, North Carolina, United States, 27534 | |
| Contact: James N. Atkins, MD 919-580-0000 | |
| Pardee Memorial Hospital | Recruiting |
| Hendersonville, North Carolina, United States, 28791 | |
| Contact: James E. Radford, MD 828-692-8045 | |
| High Point Regional Hospital | Recruiting |
| High Point, North Carolina, United States, 27261 | |
| Contact: Clinical Trials Office - High Point Regional Hospital 336-878-6107 | |
Sponsors and Collaborators
Southwest Oncology Group
Investigators
| Principal Investigator: | Laurence H. Baker, DO, FACOI | University of Michigan Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Southwest Oncology Group |
| ClinicalTrials.gov Identifier: | NCT01416688 History of Changes |
| Other Study ID Numbers: | CDR0000708371, S1013, U10CA037429 |
| Study First Received: | August 12, 2011 |
| Last Updated: | January 15, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Southwest Oncology Group:
|
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 |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Lung Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases |
Rectal Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Lung Diseases Respiratory Tract Diseases Erlotinib Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013