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

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ClinicalTrials.gov Identifier: NCT00003008
Recruitment Status : Completed
First Posted : July 11, 2003
Last Update Posted : January 28, 2010
Sponsor:
Collaborators:
National Cancer Institute (NCI)
AIDS Associated Malignancies Clinical Trials Consortium
Information provided by:
Eastern Cooperative Oncology Group

Study Description
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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.


Condition or disease Intervention/treatment Phase
Sarcoma Drug: indinavir sulfate Drug: nelfinavir mesylate Drug: paclitaxel Drug: ritonavir Drug: saquinavir mesylate Phase 2

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 33 participants
Primary Purpose: Treatment
Official Title: Pilot Study to Evaluate the Potential Interactions Between Paclitaxel and Protease Inhibitors in Patients With AIDS-Related Kaposi's Sarcoma
Study Start Date : June 1997
Actual Primary Completion Date : June 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003008


Locations
United States, Alabama
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294-3300
Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
AIDS Associated Malignancies Clinical Trials Consortium
Investigators
Study Chair: Jamie Hayden Von Roenn, MD Robert H. Lurie Cancer Center
More Information
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Responsible Party: Group Chair, Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT00003008     History of Changes
Other Study ID Numbers: CDR0000065583
E1D95
AMC-014
First Posted: July 11, 2003    Key Record Dates
Last Update Posted: January 28, 2010
Last Verified: January 2010

Keywords provided by Eastern Cooperative Oncology Group:
AIDS-related Kaposi sarcoma
recurrent Kaposi sarcoma

Additional relevant MeSH terms:
Sarcoma
Sarcoma, Kaposi
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Neoplasms, Vascular Tissue
Paclitaxel
Albumin-Bound Paclitaxel
Ritonavir
Nelfinavir
Indinavir
Saquinavir
 Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors