Tetracycline in Preventing Skin Rash in Patients Who Are Receiving Drugs Such as Gefitinib and Cetuximab for Cancer
- Conditions
- Unspecified Adult Solid Tumor, Protocol Specific
- Interventions
- Other: placebo
- Registration Number
- NCT00091247
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 130
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo placebo Patients receive oral placebo twice daily. 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. tetracycline tetracycline hydrochloride Patients receive oral tetracycline twice daily. 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.
- Primary Outcome Measures
Name Time Method 1-month incidence and severity Up to 8 weeks Rash severity Up to 8 weeks
- Secondary Outcome Measures
Name Time Method quality of life Up to 8 weeks
Trial Locations
- Locations (69)
Rush-Copley Cancer Care Center
🇺🇸Aurora, Illinois, United States
Joliet Oncology-Hematology Associates, Limited - West
🇺🇸Joliet, Illinois, United States
Carle Cancer Center at Carle Foundation Hospital
🇺🇸Urbana, Illinois, United States
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
Saint Anthony Memorial Health Centers
🇺🇸Michigan City, Indiana, United States
Cedar Rapids Oncology Associates
🇺🇸Cedar Rapids, Iowa, United States
Siouxland Hematology-Oncology Associates, LLP
🇺🇸Sioux City, Iowa, United States
Mercy Medical Center - Sioux City
🇺🇸Sioux City, Iowa, United States
St. Luke's Regional Medical Center
🇺🇸Sioux City, Iowa, United States
Cancer Center of Kansas, PA - Chanute
🇺🇸Chanute, Kansas, United States
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