Pilot Study to Evaluate the Potential Interactions Between Paclitaxel and Protease Inhibitors in Patients With AIDS-Related Kaposi's Sarcoma

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