Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005590
Status:
COMPLETED
Last Update Posted:
2013-08-02
First Post:
2000-05-02
Brief Title:
Levofloxacin to Prevent Infection Following Chemotherapy in Treating Patients With Solid Tumors or Lymphoma
Sponsor:
Cancer Research Campaign Clinical Trials Centre
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Prospective Double-Blind Placebo-Controlled Trial of Prophylactic Oral Levofloxacin Following Chemotherapy for Lymphoma and Solid Tumors
Status:
COMPLETED
Status Verified Date:
2002-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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-Hodgkins lymphoma vs Hodgkins 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 1500 patients 750 per arm will be accrued for this study within 3 years
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-Hodgkins lymphoma vs Hodgkins 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 1500 patients 750 per arm will be accrued for this study within 3 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-99054 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000067666 | REGISTRY | None | None |