Tetracycline in Preventing Skin Rash in Patients Who Are Receiving Drugs Such as Gefitinib and Cetuximab for Cancer

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alliance for Clinical Trials in Oncology
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cetuximab; Gefitinib; Tetracycline

Criteria

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