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CancerPhase 3NCT00008359

Caspofungin Acetate Compared With Amphotericin B Liposomal in Treating Patients With Persistent Fever and Neutropenia Following Cancer Treatment

A Phase 3 study testing caspofungin acetate and liposomal amphotericin B in people with Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Cancer
What is being tested?
caspofungin acetate and liposomal amphotericin B
How many people
Not given
Where
1 siteUnited States
Study dates
Aug 2000to Mar 2003
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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 amphotericin B formulation
  • No other condition or illness that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • See Disease Characteristics

Chemotherapy:

  • See Disease Characteristics
  • No concurrent investigational antineoplastic therapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • Not specified

Other:

  • At least 10 days since prior parenteral amphotericin B
  • At least 14 days since prior investigational antibiotic, antifungal, or immunosuppressive drug
  • No concurrent rifampin or cyclosporine
  • No other concurrent investigational antibiotic, antifungal, or immunosuppressive drug
  • No concurrent alcohol

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021

Other trials in United States

About this study

Official title: A Multicenter, Double-Blind, Randomized, Comparative Study To Evaluate The Safety, Tolerability, And Efficacy Of MK-0991 Versus (Amphotericin B) Liposome For Injection As Empirical Therapy In Patients With Persistent Fever And Neutropenia

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.

Read the detailed description

OBJECTIVES:

  • Compare the number of successful treatment outcomes among patients treated with caspofungin acetate vs amphotericin B liposomal for persistent fever and neutropenia following cancer therapy, in terms of survival for 7 days after study drug, resolution of fever, treatment of any baseline fungal infection, absence of breakthrough fungal infection during and for 7 days after study drug, and absence of study drug discontinuation due to toxicity or lack of efficacy.
  • Compare the incidence of nephrotoxicity in patients treated with these regimens.
  • Compare the incidence of infusion-related adverse events within 1 hour of the infusion in patients treated with these regimens.
  • Compare the incidence of treatment discontinuation due to drug-related adverse events, frequency of drug-related events, number of breakthrough fungal infections, and number of successfully treated baseline fungal infections in patients treated with these regimens.
  • Compare incidence of required dose increase due to inadequate clinical response in patients treated with these regimens.
  • Compare the time to resolution of fever in patients treated with these regimens.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to high-risk (prior allogeneic bone marrow transplantation or prior chemotherapy for relapse of acute leukemia) vs low-risk and prior prophylactic antifungal therapy during chemotherapy (yes vs no). Patients are randomized to one of two treatment arms.

  • Arm I: Patients receive caspofungin acetate IV over 1 hour followed by placebo IV over 2 hours.
  • Arm II: Patients receive placebo IV over 1 hour followed by amphotericin B liposomal IV over 2 hours.

Treatment repeats daily for up to 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed at 7 and 14 days after study drug discontinuation.

PROJECTED ACCRUAL: A total of 1060 patients (530 per arm) will be accrued for this study.

Conditions
Cancer
Being tested
caspofungin acetate, liposomal amphotericin B
Keywords
stage I adult Hodgkin lymphoma, stage II adult Hodgkin lymphoma, stage III adult Hodgkin lymphoma, stage IV adult Hodgkin lymphoma, stage IV breast cancer, stage IIIA breast cancer, monoclonal gammopathy of undetermined significance, stage IIIB 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, isolated plasmacytoma of bone, extramedullary plasmacytoma, refractory multiple myeloma, stage II ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer
Medical subject headings
Neoplasms, Hodgkin Disease, Breast Neoplasms, Monoclonal Gammopathy of Undetermined Significance, Lymphoma, T-Cell, Cutaneous, Multiple Myeloma, Carcinoma, Ovarian Epithelial, Neuroblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • caspofungin acetateDrug

  • liposomal amphotericin BDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Sep 2003 (estimated)
  2. Study startAug 2000
  3. Primary completionMar 2003

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Supportive care
Allocation
Randomised
Masking
Double blind
IDs, dates and publications
ClinicalTrials.gov ID
NCT00008359
Sponsor's protocol ID
00-085
Other IDs
MSKCC-00085, MERCK-026-01, NCI-G00-1898
Status last verified
Jan 2013
First submitted
6 Jan 2001
Last updated
18 Jan 2013
Results posted
No

Publications

  • Walsh TJ, Teppler H, Donowitz GR, Maertens JA, Baden LR, Dmoszynska A, Cornely OA, Bourque MR, Lupinacci RJ, Sable CA, dePauw BE. Caspofungin versus liposomal amphotericin B for empirical antifungal therapy in patients with persistent fever and neutropenia. N Engl J Med. 2004 Sep 30;351(14):1391-402. doi: 10.1056/NEJMoa040446.

    PubMed 15459300

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing caspofungin acetate and liposomal amphotericin B in people with Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00008359, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2013.

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