TerminatedNot Applicable

Moxifloxacin Compared With Ciprofloxacin/Amoxicillin in Treating Fever and Neutropenia in Patients With Cancer

Stopped: low accrual

Belgium, France, Germany351 participantsStarted 2002-04

Plain-language summary

RATIONALE: Antibiotics such as amoxicillin, ciprofloxacin, and moxifloxacin may be effective in preventing or controlling fever and neutropenia in patients with cancer. It is not yet known whether moxifloxacin alone is more effective than amoxicillin combined with ciprofloxacin in treating neutropenia and fever. PURPOSE: This randomized clinical trial is studying how well moxifloxacin works and compares it to ciprofloxacin together with amoxicillin in treating neutropenia and fever in patients with 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 with developing febrile neutropenia * Neutropenia defined as an absolute granulocyte count of less than 1,000/mm\^3, expected to fall to less than 500/mm\^3 within 24 hours, secondary to administration of chemotherapy and/or radiotherapy within the past 30 days * Fever defined as an oral temperature greater than 38.5ºC once, or 38°C or greater on 2 or more occasions at least 1 hour apart during a 12-hour period, and suspected to be due to infection * Expected low risk of serious medical complications as predicted by a Multinational Association for Supportive Care in Cancer risk-index score of greater than 20 * No obvious signs of exit-site or tunnel intravascular catheter infection * No known or suspected CNS infection * No known or highly suspected bacterial, viral, or fungal infection PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Not specified Life expectancy * No high probability of death within 48 hours before study enrollment (i.e., patients who are moribund or comatose for any reason with little hope of recovery OR patients in danger of, or in hepatic stupor or coma) Hematopoietic * See Disease Characteristics * No signs or symptoms of uncontrolled bleeding Hepatic * Bilirubin no greater than 3 times upper limit of normal (ULN) * Alkaline phosphatase no greater than 3 times ULN * AST and ALT no greater than 5 times ULN * No severe hepatic dysfunction Renal * Creatinine no greater than 3.…

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

Response as measured by International Antimicrobial Therapy Group (IATG) specific criteria at the completion of allocated treatment

Trial details

NCT IDNCT00062231

SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2006-10

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