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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baker Norton Pharmaceuticals
• Treatments: Albumin-Bound Paclitaxel; Antineoplastic Agents, Phytogenic; Paclitaxel

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.