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Sponsored by: |
Baker Norton Pharmaceuticals |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002189 |
To determine response rate, median time to tumor progression, qualitative and quantitative toxicity and reversibility of toxicity in patients with advanced refractory AIDS-associated Kaposi's sarcoma (KS) administered a 3-hour infusion of paclitaxel every 14 days. To evaluate the clinical benefit of paclitaxel in this patient population by evaluating self-reported responses to the Symptom Distress Scale and by documenting and evaluating any changes in their lymphedema, pain and disfiguring facial lesions.
Condition | Intervention | Phase |
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Sarcoma, Kaposi HIV Infections |
Drug: Paclitaxel |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Safety Study |
Official Title: | Paclitaxel in Advanced Refractory Kaposi's Sarcoma (AIDS-KS): A Phase II Trial of Paclitaxel From Baker Norton Pharmaceuticals |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions and symptoms are excluded:
Patients with the following prior conditions are excluded:
Completely excised in situ, carcinoma of the cervix or nonmelanomatous skin cancer.
Curatively treated other malignancy with no evidence of disease for at least 5 years.
Prior Medication:
Excluded:
Prior taxane therapy.
Required:
Study ID Numbers: | 273A, IX-110-081 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002189 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Sarcoma, Kaposi Acquired Immunodeficiency Syndrome Paclitaxel Treatment Outcome Antineoplastic Agents, Phytogenic |
Sexually Transmitted Diseases, Viral Acquired Immunodeficiency Syndrome Sarcoma, Kaposi Antimitotic Agents Immunologic Deficiency Syndromes Kaposi Sarcoma Herpesviridae Infections Virus Diseases Neoplasms, Connective and Soft Tissue Soft Tissue Sarcomas |
Malignant Mesenchymal Tumor Paclitaxel HIV Infections Tubulin Modulators Sexually Transmitted Diseases Sarcoma DNA Virus Infections Antineoplastic Agents, Phytogenic Retroviridae Infections |
Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Infection Neoplasms, Connective and Soft Tissue Therapeutic Uses Neoplasms, Vascular Tissue Retroviridae Infections RNA Virus Infections Neoplasms by Histologic Type Immune System Diseases Mitosis Modulators Sarcoma, Kaposi Acquired Immunodeficiency Syndrome |
Antimitotic Agents Immunologic Deficiency Syndromes Pharmacologic Actions Herpesviridae Infections Virus Diseases Neoplasms HIV Infections Paclitaxel Tubulin Modulators Sexually Transmitted Diseases Lentivirus Infections Sarcoma DNA Virus Infections Antineoplastic Agents, Phytogenic |