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

NCT00002189 | Completed Phase 2

• 2 other identifiers: 273AIX-110-081
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sarcoma, Kaposi; HIV Infections

Keywords

Sarcoma, Kaposi; Acquired Immunodeficiency Syndrome; Paclitaxel; Treatment Outcome; Antineoplastic Agents, Phytogenic

Interventions

Paclitaxel DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:

Sponsors & Collaborators

• Baker Norton Pharmaceuticals: lead

Study Sites (1)

Massachusetts Gen Hosp / AIDS Oncology Research

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Sarcoma, Kaposi; HIV Infections; Acquired Immunodeficiency Syndrome

Interventions

Paclitaxel

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Sarcoma; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Last Updated: June 24, 2005

Record last verified: 1998-06

Locations

US (1)