Paclitaxel Compared With Doxorubicin in Treating Patients With Advanced AIDS-Related Kaposi's Sarcoma
NCT ID: NCT00003350
Last Updated: 2013-01-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
240 participants
INTERVENTIONAL
1999-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of Oral Sapacitabine and Oral Seliciclib in Patients With Advanced Solid Tumors
NCT00999401
PS-341 and Doxorubicin in Treating Patients With Advanced Solid Tumors
NCT00023855
Paclitaxel and ABI-007 in Treating Patients With Locally Advanced or Metastatic Solid Tumors
NCT00095914
Ribociclib and Doxorubicin in Treating Patients With Metastatic or Advanced Soft Tissue Sarcomas That Cannot Be Removed by Surgery
NCT03009201
Paclitaxel Plus L-778,123 in Treating Patients With Recurrent or Refractory Solid Tumors or Lymphomas
NCT00004057
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
I. To compare the effect of therapy with paclitaxel to therapy with liposomal doxorubicin on progression-free survival and on global assessment of quality of life of subjects with advanced AIDS-related K.S.
II. To compare the toxicity profile of intravenous paclitaxel with liposomal doxorubicin in patients with advanced AIDS-related K.S.
III. To compare the overall and complete response rate of intravenous paclitaxel with liposomal doxorubicin in patients with advanced AIDS-related K.S.
IV. To evaluate the effect of intravenous paclitaxel as compared with therapy with liposomal doxorubicin on the clinical course of HIV infection in patients with advanced AIDS-related K.S., by monitoring CD4 and CD8 lymphocyte subsets, HIV viral load and the incidence and type of opportunistic infections.
V. To explore the relationship between viral load and response to the therapy for patients with AIDS-related K.S.
VI. To describe the relationship between "technical" response as measured by the current KS response criteria and the clinical benefit of therapy as measured by the revised KS clinical benefit criteria.
OUTLINE: This is a randomized study. Patients are randomized to receive either paclitaxel (arm I) or doxorubicin HCL liposome(arm II).
Arm I: Patients receive paclitaxel over 3 hours by intravenous infusion. Treatment course repeats every 2 weeks. Patients are evaluated every third course.
Arm II: Patients receive doxorubicin HCL liposome over 30-60 minutes by intravenous infusion. Treatment course is repeated every 3 weeks. Patients are evaluated before every odd course.
Patients in both arms continue treatment if there is no disease progression or unacceptable toxicity. Patients with complete response continue on study treatment for 2 courses beyond documented complete response.
Quality of life is assessed before, during, and after treatment.
Patients are followed every 3 months for the first 2 years, then every 6 months for years 2-5, and then annually thereafter.
PROJECTED ACCRUAL: There will be 240 patients (120 patients in each arm) accrued into this study over 24 months.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm I (paclitaxel)
Patients receive paclitaxel over 3 hours by intravenous infusion. Treatment course repeats every 2 weeks. Patients are evaluated every third course.
Patients in both arms continue treatment if there is no disease progression or unacceptable toxicity. Patients with complete response continue on study treatment for 2 courses beyond documented complete response.
Quality of life is assessed before, during, and after treatment.
paclitaxel
Given IV
laboratory biomarker analysis
Correlative studies
quality-of-life assessment
Ancillary studies
Arm II (pegylated liposomal doxorubicin hydrochloride)
Patients receive doxorubicin HCL liposome over 30-60 minutes by intravenous infusion. Treatment course is repeated every 3 weeks. Patients are evaluated before every odd course.
Patients in both arms continue treatment if there is no disease progression or unacceptable toxicity. Patients with complete response continue on study treatment for 2 courses beyond documented complete response.
Quality of life is assessed before, during, and after treatment.
pegylated liposomal doxorubicin hydrochloride
Given IV
laboratory biomarker analysis
Correlative studies
quality-of-life assessment
Ancillary studies
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
paclitaxel
Given IV
pegylated liposomal doxorubicin hydrochloride
Given IV
laboratory biomarker analysis
Correlative studies
quality-of-life assessment
Ancillary studies
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Biopsy-proven, measurable Kaposi's sarcoma with any of the following:
* Progressive cutaneous disease
* Symptomatic oropharyngeal or conjunctival lesions
* Any visceral involvement
* Tumor-related lymphedema
* Tumor-related ulceration or pain
* NOTE: All patients must have measurable disease; baseline measurements must be obtained \< 4 weeks prior to registration
* ECOG performance status 0-2
* ANC \>= 1000/mm³ (with or without the use of colony-stimulating factors)
* Platelet count \>= 50,000/mm³
* Hemoglobin \>= 8 gm/dL
* Bilirubin \< 1.5 x the upper limit of normal (unless elevation is due to Crixivan administration with isolated elevation in conjugated bilirubin)
* SGOT or SGPT =\< 5 x the upper limit of normal
* Creatinine =\< 2.1 mg/dl
* Women must not be pregnant or lactating due to potential toxicity of therapy
* Women of childbearing potential and sexually active men must be advised to use an accepted and effective method of contraception due to potential toxicity of therapy
* No prior systemic cytotoxic chemotherapy for Kaposi's sarcoma
* Prior radiation therapy must have been discontinued \>= 7 days prior to randomization and must NOT have been delivered to marker lesions; (NOTE: Radiation therapy will not be permitted during study treatment)
* No active, untreated infection (no new opportunistic infectious complications within the previous week requiring a change in antibiotics); maintenance therapy for opportunistic infections will be allowed
* No prior or concomitant malignancy other than curatively treated carcinoma in situ of the cervix or basal/squamous cell carcinoma of the skin
* No neuropsychiatric history or altered mental status that might prevent informed consent or affect the ability of the patient to comply with the study
* Institutions must ask patients to participate in the quality of life portion of the protocol; however, patients may decline participation in this component of the study and still be eligible; the reason for refusal or inability to complete the QOL assessments must be documented in the Assessment Compliance Form (#596)
* Must not be known to be sensitive to E. coli derived proteins
* No history of cardiac insufficiency (NY Heart Association status \>= 2)
* Patients must be on stable (no change in drugs or doses) antiretroviral therapy for greater than 14 days prior to study; a combination regimen is required; ideally this will be a protease inhibitor containing triple therapy regimen
* Patients must give signed, written informed consent
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jamie Von Roenn
Role: PRINCIPAL_INVESTIGATOR
Eastern Cooperative Oncology Group
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Eastern Cooperative Oncology Group
Boston, Massachusetts, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
E1D96
Identifier Type: -
Identifier Source: secondary_id
CDR0000066331
Identifier Type: REGISTRY
Identifier Source: secondary_id
NCI-2012-03149
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.