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


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Sarcoma, Ewing's Family of Tumors


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

This study is no longer recruiting patients.

Sponsors and Collaborators: National Cancer Institute (NCI)
AIDS Associated Malignancies Clinical Trials Consortium
Eastern Cooperative Oncology Group
Information provided by: National Cancer Institute (NCI)

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

Further Study Details: 

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:

--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

Study chairs or principal investigators

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

Study ID Numbers:  CDR0000065583; E-1D95
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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October 8, 2008



Page Updated: September 23, 2004
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