Pilot Study to Evaluate the Potential Interactions Between Paclitaxel and Protease Inhibitors in Patients With AIDS-Related Kaposi's Sarcoma
indinavir sulfate
+ nelfinavir mesylate
+ paclitaxel
DNA Virus Infections+7
+ Herpesviridae Infections
+ Infections
Treatment Study
Summary
Study start date: December 15, 1997
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.33 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 120 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, United StatesOpen University of Alabama at Birmingham Comprehensive Cancer Center in Google Maps