NCT00002985

Brief 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. 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 1996

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
4.6 years until next milestone

First Posted

Study publicly available on registry

May 19, 2004

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Last Updated

February 4, 2013

Status Verified

February 1, 2013

Enrollment Period

10.2 years

First QC Date

November 1, 1999

Last Update Submit

February 1, 2013

Conditions

Sarcoma

Keywords

AIDS-related Kaposi sarcoma

Interventions

daunorubicin hydrochlorideDRUG
pegylated liposomal doxorubicin hydrochlorideDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

MeSH Terms

Conditions

SarcomaAIDS-related Kaposi sarcoma

Interventions

Daunorubicin

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

AnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydrates

Study Officials

  • Lawrence P. Leichman, MD

    Albany Medical College

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

May 19, 2004

Study Start

November 1, 1996

Primary Completion

January 1, 2007

Last Updated

February 4, 2013

Record last verified: 2013-02

Locations

US(1)