Paclitaxel in Advanced Refractory Kaposi's Sarcoma (AIDS-KS): A Phase II Trial of Paclitaxel From Baker Norton Pharmaceuticals
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ClinicalTrials.gov Identifier: NCT00002189 |
Recruitment Status
:
Completed
First Posted
: August 31, 2001
Last Update Posted
: June 24, 2005
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Sarcoma, Kaposi HIV Infections | Drug: Paclitaxel | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Primary Purpose: | Treatment |
Official Title: | Paclitaxel in Advanced Refractory Kaposi's Sarcoma (AIDS-KS): A Phase II Trial of Paclitaxel From Baker Norton Pharmaceuticals |


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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
- Microscopically confirmed diagnosis of KS associated with HIV for which systematic therapy is medically indicated by the presence of at least one of the following:
A. >= 25 mucocutaneous (mouth or skin) lesions. B. Symptomatic visceral involvement. C. Symptomatic lymphedema (pain).
- Minimum of 5 clearly measurably cutaneous lesions by physical exam or measurable disease by X-ray, CT or MRI.
- Failed at least one systemic chemotherapy regimen.
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions and symptoms are excluded:
- Less than 2 weeks since major surgery.
- Serious uncontrolled infection. NOTE:
- Must be ruled out by thorough work-up in patients with unexplained fevers, night sweats, or involuntary weight loss of more than 10% normal weight.
- Leukopenia.
- Thrombocytopenia.
Patients with the following prior conditions are excluded:
- History of angina or myocardial infarction within the past 6 months.
- Second degree or third degree atrioventricular block without a pacemaker.
- Congestive heart failure (poorly controlled).
- History of prior malignancy except:
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:
- At least one systemic chemotherapy regimen that failed to maintain significant benefit. NOTE:
- Intralesional chemotherapy regimens are not considered as prior chemotherapy.
- At least 2 weeks since last dose of prior systemic chemotherapy.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002189
United States, Massachusetts | |
Massachusetts Gen Hosp / AIDS Oncology Research | |
Boston, Massachusetts, United States, 02114 |
ClinicalTrials.gov Identifier: | NCT00002189 History of Changes |
Other Study ID Numbers: |
273A IX-110-081 |
First Posted: | August 31, 2001 Key Record Dates |
Last Update Posted: | June 24, 2005 |
Last Verified: | June 1998 |
Keywords provided by NIH AIDS Clinical Trials Information Service:
Sarcoma, Kaposi Acquired Immunodeficiency Syndrome Paclitaxel Treatment Outcome Antineoplastic Agents, Phytogenic |
Additional relevant MeSH terms:
HIV Infections Sarcoma Sarcoma, Kaposi Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type |
Neoplasms Herpesviridae Infections DNA Virus Infections Neoplasms, Vascular Tissue Paclitaxel Antineoplastic Agents, Phytogenic Albumin-Bound Paclitaxel Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |