search
Back to results

Paclitaxel in Treating Patients With AIDS-Related Kaposi's Sarcoma

Primary Purpose

Sarcoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
indinavir sulfate
nelfinavir mesylate
paclitaxel
ritonavir
saquinavir mesylate
Sponsored by
Eastern Cooperative Oncology Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcoma focused on measuring AIDS-related Kaposi sarcoma, recurrent Kaposi sarcoma

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
June 14, 2023
Sponsor
Eastern Cooperative Oncology Group
Collaborators
National Cancer Institute (NCI), AIDS Associated Malignancies Clinical Trials Consortium
search

1. Study Identification

Unique Protocol Identification Number
NCT00003008
Brief Title
Paclitaxel in Treating Patients With AIDS-Related Kaposi's Sarcoma
Official Title
Pilot Study to Evaluate the Potential Interactions Between Paclitaxel and Protease Inhibitors in Patients With AIDS-Related Kaposi's Sarcoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
December 15, 1997 (Actual)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Eastern Cooperative Oncology Group
Collaborators
National Cancer Institute (NCI), AIDS Associated Malignancies Clinical Trials Consortium

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma
Keywords
AIDS-related Kaposi sarcoma, recurrent Kaposi sarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
33 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
indinavir sulfate
Intervention Type
Drug
Intervention Name(s)
nelfinavir mesylate
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Intervention Type
Drug
Intervention Name(s)
ritonavir
Intervention Type
Drug
Intervention Name(s)
saquinavir mesylate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jamie Hayden Von Roenn, MD
Organizational Affiliation
Robert H. Lurie Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama at Birmingham Comprehensive Cancer Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-3300
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Paclitaxel in Treating Patients With AIDS-Related Kaposi's Sarcoma

We'll reach out to this number within 24 hrs