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

This study has been completed.
Sponsor:
Collaborators:
AIDS Associated Malignancies Clinical Trials Consortium
Information provided by:
Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier:
NCT00003008
First received: November 1, 1999
Last updated: January 26, 2010
Last verified: January 2010

November 1, 1999
January 26, 2010
June 1997
June 2006   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00003008 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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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.

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.

Interventional
Phase 2
Primary Purpose: Treatment
Sarcoma
  • Drug: indinavir sulfate
  • Drug: nelfinavir mesylate
  • Drug: paclitaxel
  • Drug: ritonavir
  • Drug: saquinavir mesylate
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
Not Provided
June 2006   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003008
CDR0000065583, E1D95, AMC-014
No
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