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

NCT ID: NCT00002189

Last Updated: 2005-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL

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.

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.

Conditions

Sarcoma, Kaposi; HIV Infections

Study Design

• Primary Study Purpose: TREATMENT

Interventions

Paclitaxel

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baker Norton Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Locations

Massachusetts Gen Hosp / AIDS Oncology Research

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

IX-110-081

Identifier Type: -

Identifier Source: secondary_id

273A

Identifier Type: -

Identifier Source: org_study_id