CompletedNot Applicable

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

United States130 participantsStarted 2004-12

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Rash severity

Timeframe: Up to 8 weeks

1-month incidence and severity

Timeframe: Up to 8 weeks

Trial details

NCT IDNCT00091247

SponsorAlliance for Clinical Trials in Oncology

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2005-08

View on ClinicalTrials.gov More Unspecified Adult Solid Tumor, Protocol Specific trials