Clinical trial · Interventional
Paclitaxel in Treating Patients With AIDS-Related Kaposi's Sarcoma
Pilot Study to Evaluate the Potential Interactions Between Paclitaxel and Protease Inhibitors in Patients With AIDS-Related Kaposi's Sarcoma
NCT00003008CI-TRIAL-00067191completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| indinavir sulfate | Drug | — | UNRESOLVED |
| nelfinavir mesylate | Drug | — | UNRESOLVED |
| paclitaxel | Drug | Paclitaxel | ALIAS |
| ritonavir | Drug | — | UNRESOLVED |
| saquinavir mesylate | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.