Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00091247
Status:
COMPLETED
Last Update Posted:
2017-03-16
First Post:
2004-09-07
Brief Title:
Tetracycline in Preventing Skin Rash in Patients Who Are Receiving Drugs Such as Gefitinib and Cetuximab for Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
An Exploratory Placebo-Controlled Trial of Prophylactic Tetracycline for Gefitinib-or Cetuximab-Induced Skin Rash or Other Epidermal Growth Factor Receptor EGFR Inhibitor-Induced Skin Rash
Status:
COMPLETED
Status Verified Date:
2017-03
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 Tetracycline may be effective in preventing skin rash that is caused by treatment with drugs such as gefitinib or cetuximab
PURPOSE This randomized clinical trial is studying tetracycline to see how well it works compared to placebo in preventing skin rash in patients who are receiving drugs such as gefitinib or cetuximab for cancer
PURPOSE This randomized clinical trial is studying tetracycline to see how well it works compared to placebo in preventing skin rash in patients who are receiving drugs such as gefitinib or cetuximab for cancer
Detailed Description:
OBJECTIVES
Compare the 1-month incidence and severity of gefitinib- cetuximab- or other epidermal growth factor receptor inhibitor-induced skin rash development in patients with cancer treated with tetracycline vs placebo
Compare the toxicity of these drugs in these patients
Compare the quality of life of patients treated with these drugs who develop vs those who do not develop a rash
Determine whether patients who discontinue tetracycline at 1 month develop a rash
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to prior chemotherapy regimen first-line therapy vs other concurrent epidermal growth factor receptor inhibitor therapy gefitinib vs cetuximab vs other and concurrent corticosteroid therapy yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral tetracycline twice daily
Arm II Patients receive oral placebo twice daily In both arms treatment continues for 4 weeks in the absence of unacceptable toxicity
Quality of life is assessed at baseline and then weekly for 8 weeks
Patients are followed at weeks 4 and 8
PROJECTED ACCRUAL A total of 126 patients will be accrued for this study
Compare the 1-month incidence and severity of gefitinib- cetuximab- or other epidermal growth factor receptor inhibitor-induced skin rash development in patients with cancer treated with tetracycline vs placebo
Compare the toxicity of these drugs in these patients
Compare the quality of life of patients treated with these drugs who develop vs those who do not develop a rash
Determine whether patients who discontinue tetracycline at 1 month develop a rash
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to prior chemotherapy regimen first-line therapy vs other concurrent epidermal growth factor receptor inhibitor therapy gefitinib vs cetuximab vs other and concurrent corticosteroid therapy yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral tetracycline twice daily
Arm II Patients receive oral placebo twice daily In both arms treatment continues for 4 weeks in the absence of unacceptable toxicity
Quality of life is assessed at baseline and then weekly for 8 weeks
Patients are followed at weeks 4 and 8
PROJECTED ACCRUAL A total of 126 patients will be accrued for this study
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 |
|---|---|---|---|
| CDR0000385682 | REGISTRY | PDQ Physician Data Query | None |
| NCI-2011-01620 | REGISTRY | None | None |