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Sponsors and Collaborators: |
Eastern Cooperative Oncology Group National Cancer Institute (NCI) AIDS Associated Malignancies Clinical Trials Consortium Southwest Oncology Group |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003350 |
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 paclitaxel is more effective than doxorubicin in treating patients with advanced AIDS-related Kaposi's sarcoma.
PURPOSE: Randomized phase III trial to compare the effectiveness of paclitaxel with that of doxorubicin in treating patients who have advanced AIDS-related Kaposi's sarcoma.
Condition | Intervention | Phase |
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Sarcoma |
Drug: paclitaxel Drug: pegylated liposomal doxorubicin hydrochloride |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | Phase III Study of Paclitaxel Versus Liposomal Doxorubicin for the Treatment of Advanced AIDS-Associated Kaposi's Sarcoma |
Estimated Enrollment: | 240 |
Study Start Date: | November 1998 |
OBJECTIVES:
OUTLINE: This is a randomized study. Patients are randomized to receive either paclitaxel (arm I) or doxorubicin HCL liposome(arm II).
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed Kaposi's sarcoma, by biopsy, with any of the following:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Neurological:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Alabama | |
AIDS Associated Malignancies Clinical Trials Consortium | |
Birmingham, Alabama, United States, 35233 |
Study Chair: | Jamie Hayden Von Roenn, MD | Robert H. Lurie Cancer Center |
Study Chair: | Jamie Hayden Von Roenn, MD | Robert H. Lurie Cancer Center |
Study Chair: | Bryan Russell Leigh, MD | University of California, Davis |
Study ID Numbers: | CDR0000066331, E-1D96, AMC-009, SWOG-E1D96, CPMC-IRB-9905 |
Study First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003350 History of Changes |
Health Authority: | United States: Federal Government |
AIDS-related Kaposi sarcoma |
Sarcoma, Kaposi Antimitotic Agents Doxorubicin Herpesviridae Infections Kaposi Sarcoma Virus Diseases Neoplasms, Connective and Soft Tissue Anti-Bacterial Agents |
Malignant Mesenchymal Tumor Soft Tissue Sarcomas Paclitaxel Tubulin Modulators Sarcoma DNA Virus Infections Antineoplastic Agents, Phytogenic |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Sarcoma, Kaposi Antimitotic Agents Antibiotics, Antineoplastic Pharmacologic Actions Doxorubicin Herpesviridae Infections |
Virus Diseases Neoplasms, Connective and Soft Tissue Neoplasms Paclitaxel Therapeutic Uses Tubulin Modulators Sarcoma Neoplasms, Vascular Tissue DNA Virus Infections Antineoplastic Agents, Phytogenic |