Sarcoma, Ewing's Family of Tumors |
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Clinical Trial: Paclitaxel in Treating Patients With AIDS-Related Kaposi's Sarcoma
This study is no longer recruiting patients.
Purpose
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.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| epidemic Kaposi's sarcoma recurrent Kaposi's sarcoma | Procedure: chemotherapy Procedure: antiviral therapy Drug: indinavir Drug: nelfinavir mesylate Drug: paclitaxel Drug: ritonavir Drug: saquinavir mesylate | Phase II |
MedlinePlus related topics: Kaposi's Sarcoma
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Pilot Study to Evaluate the Potential Interactions Between Paclitaxel and Protease Inhibitors in Patients With AIDS-Related Kaposi's Sarcoma
Study start: December 1998
OBJECTIVES: I. Determine whether the body distribution and plasma clearance of paclitaxel is affected by protease inhibitors (e.g., indinavir, ritonavir, saquinavir mesylate, or nelfinavir mesylate).
PROTOCOL 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.
Eligibility
Ages Eligible for Study: 18 Years and above
Criteria
PROTOCOL ENTRY 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
--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
--Patient Characteristics--
Age: 18 and over
Performance status: ECOG 0-2
Life expectancy: Not specified
Hematopoietic:
- Absolute neutrophil count at least 1,000/mm3 (with or without the use of colony-stimulating factors)
- Platelet count at least 50,000/mm3
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
Location Information
Alabama
University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, Alabama, 35294-3300, United States
Robert L. Comis, Study Chair, Eastern Cooperative Oncology Group
Jamie Hayden Von Roenn, Study Chair
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Record last reviewed: July 2003
Last Updated: October 13, 2004
Record first received: November 1, 1999
ClinicalTrials.gov Identifier: NCT00003008
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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