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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003008
Recruitment Status : Completed
First Posted : July 11, 2003
Last Update Posted : January 28, 2010
National Cancer Institute (NCI)
AIDS Associated Malignancies Clinical Trials Consortium
Information provided by:
Eastern Cooperative Oncology Group

November 1, 1999
July 11, 2003
January 28, 2010
June 1997
June 2006   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00003008 on Archive Site
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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

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.


  • 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.

Phase 2
Primary Purpose: Treatment
  • Drug: indinavir sulfate
  • Drug: nelfinavir mesylate
  • Drug: paclitaxel
  • Drug: ritonavir
  • Drug: saquinavir mesylate
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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June 2006   (Final data collection date for primary outcome measure)


  • 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



  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified


  • 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


  • 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


  • Creatinine no greater than 1.5 mg/dL OR
  • Creatinine clearance greater than 60 mL/min


  • No greater than grade 2 peripheral neuropathy
  • No neuropsychiatric history or altered mental status that would preclude study


  • 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


Biologic therapy:

  • Not specified


  • See Disease Characteristics

Endocrine therapy:

  • Not specified


  • At least 1 week since prior radiotherapy
  • No prior radiotherapy to marker lesions
  • No concurrent radiotherapy


  • Not specified


  • 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Group Chair, Eastern Cooperative Oncology Group
Eastern Cooperative Oncology Group
  • National Cancer Institute (NCI)
  • AIDS Associated Malignancies Clinical Trials Consortium
Study Chair: Jamie Hayden Von Roenn, MD Robert H. Lurie Cancer Center
Eastern Cooperative Oncology Group
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP