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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase III Randomized Study of Prophylactic Levofloxacin After Chemotherapy in Patients With Solid Tumors or Lymphoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Supportive care	Closed	16 and over	Other	CRC-TU-SIGNIFICANT EU-99054, NCT00005590

Trial Description

Purpose:

Giving antibiotics may be effective in preventing or controlling early infection in patients receiving chemotherapy for solid tumors or lymphoma. It is not yet known if levofloxacin if effective in preventing infection.

Randomized phase III trial to determine the effectiveness of levofloxacin in preventing infection in patients receiving chemotherapy for solid tumors or lymphoma.

Eligibility:

• At least 16 years old
• About to start a course of chemotherapy that does not require filgrastim or peripheral stem cell transplantation
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will be randomly assigned to one of two groups. Patients in group one will receive levofloxacin by mouth once a day for 1 week. Patients in group two will receive a placebo by mouth once a day for 1 week. Treatment may be repeated for up to six courses.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

Cancer Research UK Clinical Trials Unit - Birmingham

Steven Neil, MB, MA, BS, PhD, DTMH, MRCP, Protocol chair		Ph: 44-121-414-2803 Email: n.m.steven@bham.ac.uk

Registry Information
Official Title		A Randomized, Prospective Double-Blind, Placebo-Controlled Trial of Prophylactic Oral Levofloxacin Following Chemotherapy for Lymphoma and Solid Tumors
Trial Start Date		1999-08-03
Registered in ClinicalTrials.gov		NCT00005590
Date Submitted to PDQ		2000-02-11
Information Last Verified		2002-07-31

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