Caspofungin Acetate Compared With Amphotericin B Liposomal in Treating Patients With Persistent F… (NCT00008359) | Clinical Trial Compass
CompletedPhase 3
Caspofungin Acetate Compared With Amphotericin B Liposomal in Treating Patients With Persistent Fever and Neutropenia Following Cancer Treatment
United StatesStarted 2000-08
Plain-language summary
RATIONALE: Caspofungin acetate or amphotericin B liposomal may be effective in preventing or controlling fever and neutropenia caused by chemotherapy, bone marrow transplantation, or peripheral stem cell transplantation. It is not yet known whether caspofungin acetate or amphotericin B liposomal is more effective for treating these side effects.
PURPOSE: Randomized phase III trial to compare the effectiveness of caspofungin acetate with that of amphotericin B liposomal in treating patients who have persistent fever and neutropenia after receiving anticancer therapy.
Who can participate
Age range
16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Leukemia, lymphoma, or other cancer that has been previously treated with chemotherapy or bone marrow or peripheral blood stem cell transplantation
* Absolute neutrophil count less than 500/mm\^3 for past 96 hours and not expected to recover in next 48 hours
* Received at least 96 hours of parenteral systemic antibacterial therapy
* Fever greater than 38.0 degrees Celsius
* Adequately managed bacterial infection allowed if all of the following are true:
* Negative blood cultures
* Received at least 5 days of antibiotics to which any bacterial isolates are sensitive
* Surgical drainage of any abscess fluid or surgical debridement of infected tissues
* Removal of infected catheters
* No invasive fungal infection
* Not previously enrolled on this study
PATIENT CHARACTERISTICS:
Age:
* 16 and over
Performance status:
* Karnofsky 30-100%
Life expectancy:
* At least 5 days
Hematopoietic:
* Platelet count at least 5,000/mm\^3
* INR no greater than 1.6 (no greater than 4.0 if receiving anticoagulants)
Hepatic:
* Bilirubin no greater than 3 times upper limit of normal (ULN)
* AST or ALT no greater than 5 times ULN
* Alkaline phosphatase no greater than 3 times ULN
* No acute hepatitis or cirrhosis
Renal:
* Not specified
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective barrier contraception
* No allergy, hypersensitivity, or prior serious reaction to any echinocandin antifungal or amphote…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.