Status:
COMPLETED
Tetracycline in Preventing Skin Rash in Patients Who Are Receiving Drugs Such as Gefitinib and Cetuximab for Cancer
Lead Sponsor:
Alliance for Clinical Trials in Oncology
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
All Genders
18+ years
Phase:
NA
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 tetracyclin...
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 w...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of cancer
- Began therapy within the past 7 days or plans to begin therapy within 7 days after study entry with one of the following epidermal growth factor receptor inhibitors:
- Gefitinib
- Cetuximab
- Erlotinib
- Monoclonal antibody ABX-EGF
- ICR-62
- CI-1033
- EMD-72000
- No rash at study entry
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Hepatic
- Bilirubin ≤ 2 mg/dL
- Renal
- Creatinine ≤ 2 mg/dL
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective non-hormonal contraception
- Able to take oral medication
- No history of skin condition that may flare during study treatment
- No prior allergic reaction or severe intolerance to tetracycline or one of its derivatives
- No severe nausea or vomiting that would preclude retaining study drug
- PRIOR CONCURRENT THERAPY:
- Other
- More than 1 week since prior tetracycline
- No milk products, antacids, or calcium supplements for 2 hours before until 2 hours after drug administration
- No other concurrent tetracycline
Exclusion
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT00091247
Start Date
December 1 2004
End Date
July 1 2009
Last Update
March 16 2017
Active Locations (69)
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1
Rush-Copley Cancer Care Center
Aurora, Illinois, United States, 60504
2
Joliet Oncology-Hematology Associates, Limited - West
Joliet, Illinois, United States, 60435
3
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois, United States, 61801
4
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801