Paclitaxel in Treating Patients With AIDS-Related Kaposi's Sarcoma

Eastern Cooperative Oncology Group33 enrolled

Overview

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients with AIDS-related Kaposi's sarcoma.

OBJECTIVES: * Determine whether the body distribution and plasma clearance of paclitaxel is affected by protease inhibitors (e.g., indinavir, ritonavir, saquinavir mesylate, or nelfinavir mesylate). OUTLINE: Patients are stratified according to protease inhibitor treatment (yes vs no), prior paclitaxel (yes vs no), and prior doxorubicin or daunorubicin (yes vs no). Patients receive paclitaxel IV over 3 hours on day 1. Treatment continues every 2 weeks for at least 1 course in the absence of disease progression or unacceptable toxicity. Patients who previously received paclitaxel receive no more than 1 course during this study. PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Enrollment

Conditions

Sarcoma

Interventions

indinavir sulfateDRUG

nelfinavir mesylateDRUG

paclitaxelDRUG

ritonavirDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: * Histologically confirmed Kaposi's sarcoma requiring chemotherapy and/or currently being treated with paclitaxel * Serologic diagnosis of HIV infection documented by a positive ELISA and confirmed with a Western Blot or other federally approved HIV diagnostic test PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,000/mm \^3(with or without the use of colony-stimulating factors) * Platelet count at least 50,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * AST no greater than 2.5 times ULN * Alkaline phosphatase no greater than 2.5 times ULN Renal: * Creatinine no greater than 1.5 mg/dL OR * Creatinine clearance greater than 60 mL/min Neurologic: * No greater than grade 2 peripheral neuropathy * No neuropsychiatric history or altered mental status that would preclude study Other: * Not pregnant or nursing * Fertile patients must use effective contraception * No other prior or concurrent malignancy except curatively treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer * No sensitivity to E. coli-derived proteins * No active untreated infection * No new infectious complications requiring a change in antibiotics within the past 2 weeks PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics Endocrine therapy: * Not specified Radiotherapy: * At least 1 week since prior radiotherapy * No prior radiotherapy to marker lesions * No concurrent radiotherapy Surgery: * Not specified Other: * At least 2 weeks since prior systemic treatment for Kaposi's sarcoma * At least 2 weeks since prior nonapproved FDA investigational agents except available Investigational New Drugs that are antiretroviral agents * Concurrent maintenance therapy for opportunistic infections allowed * Concurrent commercially available antiretroviral therapy allowed

Locations (1)

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, United States

Data from ClinicalTrials.gov

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