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Clinical Trial: Paclitaxel in Advanced Refractory Kaposi's Sarcoma (AIDS-KS): A Phase II Trial of Paclitaxel from Baker Norton Pharmaceuticals
This study has been completed.
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Purpose
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 | Treatment or Intervention | Phase |
|---|---|---|
| Sarcoma, Kaposi HIV Infections | Drug: Paclitaxel | Phase II |
MedlinePlus related topics: AIDS; Kaposi's Sarcoma
Study Type: Interventional
Study Design: Treatment, Safety Study
Patients are treated with paclitaxel intravenously every 2 weeks up to 10 courses. Patients who achieve a complete response receive 2 additional courses those who achieve partial response or stabilization, continue therapy until progression.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
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.
Location Information
Massachusetts
Massachusetts Gen Hosp / AIDS Oncology Research, Boston, Massachusetts, 02114, United States
More Information
Record last reviewed: June 1998
Last Updated: October 13, 2004
Record first received: November 2, 1999
ClinicalTrials.gov Identifier: NCT00002189
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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