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

• Status: Completed
• Trial end date: 2005-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cancer Research Campaign Clinical Trials Centre
• Treatments: Levofloxacin; Ofloxacin

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