SarcomaPhase 3NCT00002985
Doxorubicin in Treating Patients With AIDS-Related Kaposi's Sarcoma
A Phase 3 study testing daunorubicin hydrochloride and pegylated liposomal doxorubicin hydrochloride in people with Sarcoma, run by Roswell Park Cancer Institute at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether doxorubicin is more effective than daunorubicin for AIDS-related Kaposi's sarcoma. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sarcoma
- What is being tested?
- daunorubicin hydrochloride and pegylated liposomal doxorubicin hydrochloride
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Nov 1996to Jan 2007
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS: AIDS-related Kaposi's sarcoma that requires systemic chemotherapy One or more of the following (Kaposi's sarcoma- or AIDS-associated): Edema that impairs functional activity Symptomatic, evaluable pulmonary Kaposi's sarcoma documented within 3 months before study Symptomatic, evaluable GI Kaposi's sarcoma documented within 3 months before study Moderate or severe pain despite the use of analgesics Lesion(s) that patient feels are disfiguring and impair patient's self-image or daily activities At least 5 bidimensionally measurable monocutaneous lesions
PATIENT CHARACTERISTICS: Age: Not specified Performance status: Karnofsky 40-100% Life expectancy: At least 120 days Hematopoietic: Neutrophil count at least 1,200 cells/mm3 Platelet count at least 75,000 cells/mm3 Hemoglobin at least 9.0 g/dL Hepatic: Creatinine less than 2 times upper limit of normal (ULN) Bilirubin less than 2 times ULN Renal: Not specified Cardiovascular: Cardiac ejection fraction at least 50% No histopathological evidence of antracycline-induced cardiomyopathy Pulmonary: No significant non-Kaposi's sarcoma associated pulmonary insufficiency (defined as oxygen saturation less than 90%) Other: Not pregnant or nursing Fertile women must be using medically proven method of birth control No opportunistic infection in the past 4 weeks No other active malignancies except basal or squamous cell carcinoma of the skin or in situ cervical or anal carcinoma No neuropsychiatric history or altered mental status that prevents informed consent or compliance with protocol requirements
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 14 days since prior anti-Kaposi's sarcoma therapy No prior Doxil or DaunoXome No concurrent cytotoxic chemotherapy Endocrine therapy: Not specified Radiotherapy: No concurrent radiation therapy Surgery: Not specified Other: Antiviral therapy allowed Colony stimulating factors allowed Erythropoietin allowed Prophylactic therapy, maintenance therapy and treatment for HIV-associated opportunistic infections allowed
Trial locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
About this study
Official title: Double-Blind Randomized Evaluation of Clinical Benefits of DOXIL in Patients With AIDS-Related Kaposi's Sarcoma Treated With DOXIL or DaunoXome
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether doxorubicin is more effective than daunorubicin for AIDS-related Kaposi's sarcoma.
PURPOSE: Randomized double-blinded phase III trial to determine if doxorubicin is more effective than daunorubicin in treating patients who have AIDS-related Kaposi's sarcoma.
Read the detailed description
OBJECTIVES: I. Evaluate the clinical benefit of doxorubicin HCl liposome (Doxil) compared to baseline status in the treatment of AIDS-related Kaposi's sarcoma. II. Determine tumor response to Doxil as a corollary to clinical benefit. III. Evaluate the safety of Doxil.
OUTLINE: This is a randomized, prospective, double blind, multicenter study. Patients are randomly assigned to receive doxorubicin HCl liposome (Doxil) or daunorubicin (DaunoXome) in a 3:1 ratio. Both Doxil and DauonoXome are given every 2 weeks for 6 courses by intravenous infusion over 60 minutes into a peripheral vein.
PROJECTED ACCRUAL: 80 patients will be studied.
- Conditions
- Sarcoma
- Being tested
- daunorubicin hydrochloride, pegylated liposomal doxorubicin hydrochloride
- Keywords
- AIDS-related Kaposi sarcoma
- Medical subject headings
- Sarcoma, AIDS-related Kaposi sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
daunorubicin hydrochlorideDrug
pegylated liposomal doxorubicin hydrochlorideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2004 (estimated)
- Study startNov 1996
- Primary completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Investigators
- Lawrence P. Leichman, MD, Study chair, Albany Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002985
- Sponsor's protocol ID
- DS 96-28
- Other IDs
- RPCI-DS-96-28, SEQUUS-30-38, NCI-G97-1241
- Status last verified
- Feb 2013
- First submitted
- 1 Nov 1999
- Last updated
- 4 Feb 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind Randomized Evaluation of Clinical Benefits of DOXIL in Patients With AIDS-Related Kaposi's Sarcoma Treated With DOXIL or DaunoXome
- ClinicalTrials.gov ID
- NCT00002985
- Acronym / sponsor ID
- DS 96-28
- Conditions
- Sarcoma
- Keywords
- AIDS-related Kaposi sarcoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- Nov 1996
- Primary completion
- Jan 2007 (actual)
- First posted
- 19 May 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether doxorubicin is more effective than daunorubicin for AIDS-related Kaposi's sarcoma.
PURPOSE: Randomized double-blinded phase III trial to determine if doxorubicin is more effective than daunorubicin in treating patients who have AIDS-related Kaposi's sarcoma.
Detailed description
OBJECTIVES: I. Evaluate the clinical benefit of doxorubicin HCl liposome (Doxil) compared to baseline status in the treatment of AIDS-related Kaposi's sarcoma. II. Determine tumor response to Doxil as a corollary to clinical benefit. III. Evaluate the safety of Doxil.
OUTLINE: This is a randomized, prospective, double blind, multicenter study. Patients are randomly assigned to receive doxorubicin HCl liposome (Doxil) or daunorubicin (DaunoXome) in a 3:1 ratio. Both Doxil and DauonoXome are given every 2 weeks for 6 courses by intravenous infusion over 60 minutes into a peripheral vein.
PROJECTED ACCRUAL: 80 patients will be studied.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| daunorubicin hydrochloride | Drug | – |
| pegylated liposomal doxorubicin hydrochloride | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lawrence P. Leichman, MD study chair
Albany Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing daunorubicin hydrochloride and pegylated liposomal doxorubicin hydrochloride in people with Sarcoma, run by Roswell Park Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 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?
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 4 Feb 2013.