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

June 23, 2005 updated by: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baker Norton Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

June 1, 1998

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 273A
  • IX-110-081

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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