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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: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002189
  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 Intervention Phase
Sarcoma, Kaposi
HIV Infections
Drug: Paclitaxel
Phase II

MedlinePlus related topics:   AIDS    Kaposi's Sarcoma    Soft Tissue Sarcoma   

Drug Information available for:   Paclitaxel   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Safety Study
Official Title:   Paclitaxel in Advanced Refractory Kaposi's Sarcoma (AIDS-KS): A Phase II Trial of Paclitaxel From Baker Norton Pharmaceuticals

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Detailed Description:

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 older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002189

Locations
United States, Massachusetts
Massachusetts Gen Hosp / AIDS Oncology Research    
      Boston, Massachusetts, United States, 02114

Sponsors and Collaborators
Baker Norton Pharmaceuticals
  More Information


Study ID Numbers:   273A, IX-110-081
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002189
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  

Study placed in the following topic categories:
Sexually Transmitted Diseases, Viral
Malignant mesenchymal tumor
Acquired Immunodeficiency Syndrome
Sarcoma, Kaposi
Soft tissue sarcomas
Immunologic Deficiency Syndromes
Herpesviridae Infections
Virus Diseases
Neoplasms, Connective and Soft Tissue
Kaposi sarcoma
Paclitaxel
HIV Infections
Sexually Transmitted Diseases
Sarcoma
DNA Virus Infections
Retroviridae Infections

Additional relevant MeSH terms:
RNA Virus Infections
Slow Virus Diseases
Neoplasms by Histologic Type
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Antimitotic Agents
Infection
Pharmacologic Actions
Neoplasms
Therapeutic Uses
Tubulin Modulators
Lentivirus Infections
Neoplasms, Vascular Tissue
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on December 03, 2008




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