NCT00003008

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 1997

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.7 years until next milestone

First Posted

Study publicly available on registry

July 11, 2003

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Last Updated

June 15, 2023

Status Verified

June 1, 2023

Enrollment Period

8.5 years

First QC Date

November 1, 1999

Last Update Submit

June 14, 2023

Conditions

Sarcoma

Keywords

AIDS-related Kaposi sarcomarecurrent Kaposi sarcoma

Interventions

indinavir sulfateDRUG
nelfinavir mesylateDRUG
paclitaxelDRUG
ritonavirDRUG
saquinavir mesylateDRUG

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, 35294-3300, United States

Location

MeSH Terms

Conditions

SarcomaAIDS-related Kaposi sarcomaSarcoma, Kaposi

Interventions

IndinavirNelfinavirPaclitaxelRitonavirSaquinavir

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsNeoplasms, Vascular Tissue

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesThiazolesSulfur CompoundsAzolesQuinolines

Study Officials

  • Jamie Hayden Von Roenn, MD

    Robert H. Lurie Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
NETWORK

Study Record Dates

First Submitted

November 1, 1999

First Posted

July 11, 2003

Study Start

December 15, 1997

Primary Completion

June 1, 2006

Last Updated

June 15, 2023

Record last verified: 2023-06

Locations

US(1)