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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00002189 |
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Date of registration:
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02/11/1999 |
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Primary sponsor: |
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Public title:
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Paclitaxel in Advanced Refractory Kaposi's Sarcoma (AIDS-KS): A Phase II Trial of Paclitaxel From Baker Norton Pharmaceuticals
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Scientific title:
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Paclitaxel in Advanced Refractory Kaposi's Sarcoma (AIDS-KS): A Phase II Trial of Paclitaxel From Baker Norton Pharmaceuticals |
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Date of first enrolment:
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May 1997 |
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Target sample size:
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00002189 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety Study, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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HIV Infections
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Sarcoma, Kaposi
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Intervention(s)
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Drug: Paclitaxel
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Secondary ID(s)
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273A
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IX-110-081
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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