Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00362986
Status:
COMPLETED
Last Update Posted:
2016-12-13
First Post:
2006-08-10
Brief Title:
Topical Sunscreen in Preventing Skin Rash in Patients Receiving Drugs Such as Erlotinib or Cetuximab for Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Phase III Randomized Double-Blind Placebo-Controlled Trial of Prophylactic Topical Sunscreen to Prevent Erlotinib- or Cetuximab-Induced Skin Rash or Other Epidermal Growth Factor Receptor EGFR Inhibitor-Induced Skin Rash
Status:
COMPLETED
Status Verified Date:
2016-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Topical sunscreen may be effective in preventing skin rash caused by treatment with drugs such as erlotinib or cetuximab It is not yet known whether topical sunscreen is more effective than a placebo in preventing skin rash in patients receiving drugs such as erlotinib or cetuximab for cancer
PURPOSE This randomized phase III trial is studying topical sunscreen to see how well it works compared with a placebo in preventing skin rash in patients receiving drugs such as erlotinib or cetuximab for cancer
PURPOSE This randomized phase III trial is studying topical sunscreen to see how well it works compared with a placebo in preventing skin rash in patients receiving drugs such as erlotinib or cetuximab for cancer
Detailed Description:
OBJECTIVES
Compare the incidence and severity of erlotinib- cetuximab- or other epidermal growth factor receptor inhibitor-induced skin rash development in patients with cancer treated with prophylactic topical sunscreen vs placebo
Determine the toxicity of topical sunscreen vs placebo in these patients
Determine whether discontinuation of treatment intervention is followed by rash development
OUTLINE This is a multicenter randomized double-blind placebo-controlled study Patients are stratified according to chemotherapy regimen first-line chemotherapy vs other epidermal growth factor receptor EGFR inhibitor therapy small molecule vs monoclonal antibodies concurrent medication that increases sun hypersensitivity yes vs no and gender Patients are randomized to 1 of 2 treatment arms
Arm I Patients apply sunscreen generously to the entire body twice daily for 4 weeks
Arm I Patients apply placebo generously to the entire body twice daily for 4 weeks
Patients complete self-reported questionnaires regarding their rash status at baseline and then weekly for 8 weeks
After completion of study treatment patients are followed for 8 weeks
Compare the incidence and severity of erlotinib- cetuximab- or other epidermal growth factor receptor inhibitor-induced skin rash development in patients with cancer treated with prophylactic topical sunscreen vs placebo
Determine the toxicity of topical sunscreen vs placebo in these patients
Determine whether discontinuation of treatment intervention is followed by rash development
OUTLINE This is a multicenter randomized double-blind placebo-controlled study Patients are stratified according to chemotherapy regimen first-line chemotherapy vs other epidermal growth factor receptor EGFR inhibitor therapy small molecule vs monoclonal antibodies concurrent medication that increases sun hypersensitivity yes vs no and gender Patients are randomized to 1 of 2 treatment arms
Arm I Patients apply sunscreen generously to the entire body twice daily for 4 weeks
Arm I Patients apply placebo generously to the entire body twice daily for 4 weeks
Patients complete self-reported questionnaires regarding their rash status at baseline and then weekly for 8 weeks
After completion of study treatment patients are followed for 8 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2012-02700 | REGISTRY | None | None |
| CDR0000492254 | REGISTRY | PDQ Physician Data Query | None |