Paclitaxel in Advanced Refractory Kaposi's Sarcoma (AIDS-KS): A Phase II Trial of Paclitaxel From Baker Norton Pharmaceuticals
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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 |
---|---|---|
Sarcoma, Kaposi HIV Infections |
Drug: Paclitaxel |
Phase 2 |
Study Type: | Interventional |
Study Design: | Endpoint Classification: Safety Study Primary Purpose: Treatment |
Official Title: | Paclitaxel in Advanced Refractory Kaposi's Sarcoma (AIDS-KS): A Phase II Trial of Paclitaxel From Baker Norton Pharmaceuticals |
![](https://webarchive.library.unt.edu/web/20130225141826im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
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.
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No publications provided
ClinicalTrials.gov Identifier: | NCT00002189 History of Changes |
Other Study ID Numbers: | 273A, IX-110-081 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
Health Authority: | United States: Food and Drug Administration |
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 Acquired Immunodeficiency Syndrome Sarcoma, Kaposi Sarcoma Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Herpesviridae Infections |
DNA Virus Infections Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Neoplasms, Vascular Tissue Antineoplastic Agents Paclitaxel Antineoplastic Agents, Phytogenic Therapeutic Uses Pharmacologic Actions Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on February 21, 2013