Sarcoma
Conditions
Keywords
AIDS-related Kaposi sarcoma, recurrent Kaposi sarcoma
Brief summary
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.
Detailed description
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.
Interventions
Sponsors
National Cancer Institute (NCI)
AIDS Associated Malignancies Clinical Trials Consortium
Eastern Cooperative Oncology Group
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
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
Countries
United States
Outcome results
None listed