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

• Sponsor: Cancer Research Campaign Clinical Trials Centre
• Information provided by: National Cancer Institute (NCI)

Study Description

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.

Condition or disease	Intervention/treatment	Phase
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	Drug: levofloxacin	Phase 3

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 Design

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Study Type :	Interventional (Clinical Trial)
Allocation:	Randomized
Masking:	Double
Primary Purpose:	Supportive Care
Official Title:	A Randomized, Prospective Double-Blind, Placebo-Controlled Trial of Prophylactic Oral Levofloxacin Following Chemotherapy for Lymphoma and Solid Tumors
Study Start Date :	August 1999
Actual Study Completion Date :	September 2005

Arms and Interventions

Outcome Measures

Eligibility Criteria

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Ages Eligible for Study:	16 Years and older (Child, Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Locations

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United Kingdom
University of Birmingham
Birmingham, England, United Kingdom, B15 2TT

Sponsors and Collaborators

Cancer Research Campaign Clinical Trials Centre

Investigators

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Study Chair:	Steven M. Neil, MB, MA, BS, PhD, DTMH, MRCP	University Hospital Birmingham

More Information

Publications of Results:

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.

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ClinicalTrials.gov Identifier:	NCT00005590 History of Changes
Other Study ID Numbers:	CRC-TU-SIGNIFICANT; CDR0000067666 ( Registry Identifier: PDQ (Physician Data Query) ); EU-99054
First Posted:	January 27, 2003
Last Update Posted:	August 2, 2013
Last Verified:	July 2002

Keywords provided by National Cancer Institute (NCI):

stage I adult Hodgkin lymphoma; stage II adult Hodgkin lymphoma; stage III adult Hodgkin lymphoma; stage IV adult Hodgkin lymphoma; recurrent breast cancer; recurrent adult Hodgkin lymphoma; stage I cutaneous T-cell non-Hodgkin lymphoma; stage II cutaneous T-cell non-Hodgkin lymphoma; stage III cutaneous T-cell non-Hodgkin lymphoma; stage IV cutaneous T-cell non-Hodgkin lymphoma; recurrent cutaneous T-cell non-Hodgkin lymphoma; limited stage small cell lung cancer; extensive stage small cell lung cancer; recurrent small cell lung cancer; small intestine lymphoma

stage II malignant testicular germ cell tumor; stage III malignant testicular germ cell tumor; unspecified adult solid tumor, protocol specific; stage I grade 2 follicular lymphoma; stage I grade 3 follicular lymphoma; stage I adult diffuse small cleaved cell lymphoma; stage I adult diffuse mixed cell lymphoma; stage I adult diffuse large cell lymphoma; stage I adult immunoblastic large cell lymphoma; stage I adult lymphoblastic lymphoma; stage I adult Burkitt lymphoma; stage II ovarian germ cell tumor; stage III ovarian germ cell tumor; stage IV ovarian germ cell tumor; stage III grade 1 follicular lymphoma

Additional relevant MeSH terms:

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Lymphoma; Neoplasms; Infection; Communicable Diseases; Lung Neoplasms; Neoplasms, Germ Cell and Embryonal; Nervous System Neoplasms; Central Nervous System Neoplasms; Testicular Neoplasms; Intestinal Neoplasms; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases	Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Nervous System Diseases; Endocrine Gland Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Endocrine System Diseases; Testicular Diseases; Gonadal Disorders; Gastrointestinal Neoplasms; Digestive System Neoplasms