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Paclitaxel in Advanced Refractory Kaposi's Sarcoma (AIDS-KS): A Phase II Trial of Paclitaxel from Baker Norton Pharmaceuticals - Article


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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.

Sponsored by: Baker Norton Pharmaceuticals
Information provided by: AIDS Clinical Trials Information Service

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

Further Study Details: 

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:

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

Study ID Numbers:  273A; IX-110-081
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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