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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002189
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: June 1998

November 2, 1999
June 23, 2005
Not Provided
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00002189 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Paclitaxel in Advanced Refractory Kaposi's Sarcoma (AIDS-KS): A Phase II Trial of Paclitaxel From Baker Norton Pharmaceuticals
Paclitaxel in Advanced Refractory Kaposi's Sarcoma (AIDS-KS): A Phase II Trial of Paclitaxel From Baker Norton Pharmaceuticals

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.

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.

Interventional
Phase 2
Endpoint Classification: Safety Study
Primary Purpose: Treatment
  • Sarcoma, Kaposi
  • HIV Infections
Drug: Paclitaxel
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
Not Provided
Not Provided

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002189
273A, IX-110-081
Not Provided
Not Provided
Baker Norton Pharmaceuticals
Not Provided
Not Provided
NIH AIDS Clinical Trials Information Service
June 1998

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP