Levofloxacin to Prevent Infection Following Chemotherapy in Treating Patients With Solid Tumors or Lymphoma - Tabular View

Tracking Information

First Received Date ^ICMJE

May 2, 2000

Last Updated Date

May 9, 2009

Start Date ^ICMJE

August 1999

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00005590 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Levofloxacin to Prevent Infection Following Chemotherapy in Treating Patients With Solid Tumors or Lymphoma

Official Title ^ICMJE

A Randomized, Prospective Double-Blind, Placebo-Controlled Trial of Prophylactic Oral Levofloxacin Following Chemotherapy for Lymphoma and Solid Tumors

Brief Summary

RATIONALE: 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.

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

Detailed Description

OBJECTIVES:

Determine whether prophylactic treatment with levofloxacin reduces the rate of clinical infection in patients receiving myelosuppressive antineoplastic chemotherapy for solid tumors or lymphoma.

OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to age (under 40 vs 40-59 vs 60 and over), type of cancer (non-Hodgkin's lymphoma vs Hodgkin's lymphoma vs breast vs germ cell vs small cell lung cancer vs other), and participating center. Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive oral levofloxacin once daily for 7 consecutive days during the expected neutrophil nadir of each chemotherapy course.
Arm II: Patients receive an oral placebo once daily for 7 consecutive days as in arm I.

Treatment in both arms continues for up to 6 courses in the absence of unacceptable side effects or allergy or a clear continuing indication for the prophylactic use of antibacterial agents during subsequent courses.

PROJECTED ACCRUAL: A total of 1,500 patients (750 per arm) will be accrued for this study within 3 years.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Supportive Care, Randomized, Double-Blind, Active Control

Condition ^ICMJE

Brain and Central Nervous System Tumors
Breast Cancer
Extragonadal Germ Cell Tumor
Infection
Lung Cancer
Lymphoma
Ovarian Cancer
Small Intestine Cancer
Testicular Germ Cell Tumor
Unspecified Adult Solid Tumor, Protocol Specific

Intervention ^ICMJE

Drug: levofloxacin

Study Arms / Comparison Groups

Publications *

Cullen M, Steven N, Billingham L, Gaunt C, Hastings M, Simmonds P, Stuart N, Rea D, Bower M, Fernando I, Huddart R, Gollins S, Stanley A; Simple Investigation in Neutropenic Individuals of the Frequency of Infection after Chemotherapy +/- Antibiotic in a Number of Tumours (SIGNIFICANT) Trial Group. Antibacterial prophylaxis after chemotherapy for solid tumors and lymphomas. N Engl J Med. 2005 Sep 8;353(10):988-98.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

DISEASE CHARACTERISTICS:

Diagnosis of solid tumor, including but not limited to, the following:
- Stage II-IV germ cell malignancy
- Small cell lung cancer
- Recurrent breast cancer OR
Diagnosis of lymphoma
About to start a program of antineoplastic chemotherapy for malignant disease that will regularly induce myelosuppression with a risk of temporary severe neutropenia (i.e., neutrophil count less than 500/mm3), but does not routinely require filgrastim (G-CSF) or stem cell support
Not previously randomized into the Significant trial for a different multicourse chemotherapy program
Hormone receptor status:
- Not specified

PATIENT CHARACTERISTICS:

Age:

16 and over

Sex:

Not specified

Menopausal status:

Not specified

Performance status:

Not specified

Life expectancy:

Not specified

Hematopoietic:

See Disease Characteristics

Hepatic:

Not specified

Renal:

Creatinine normal OR
Creatinine clearance greater than 40 mL/min

Other:

Not pregnant or nursing
Fertile patients must use effective contraception in addition to oral contraceptive pills
HIV negative
No epilepsy
No history of adverse events resulting from fluoroquinolone therapy (e.g., allergy or tendinitis)
No concurrent use of a sunbed or exposure to strong sunlight

PRIOR CONCURRENT THERAPY:

Biologic therapy:

See Disease Characteristics

Chemotherapy:

See Disease Characteristics

Endocrine therapy:

Not specified

Radiotherapy:

Not specified

Surgery:

Not specified

Other:

No other concurrent antibacterial therapy
No other concurrent prophylactic antibacterial agents including cotrimoxazole prophylaxis against Pneumocystis carinii
No iron supplements, sucralfate, or mineral antacids 2 hours before or after study medication
Concurrent entry into other clinical trials allowed

Gender

Both

Ages

16 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00005590

Responsible Party

Study ID Numbers ^ICMJE

CDR0000067666, CRC-TU-SIGNIFICANT, EU-99054

Study Sponsor ^ICMJE

Cancer Research Campaign Clinical Trials Centre

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Steven M. Neil, MB, MA, BS, PhD, DTMH, MRCP

University Hospital Birmingham

Information Provided By

National Cancer Institute (NCI)

Verification Date

July 2002

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP