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

This study has been completed.
Sponsor:
Collaborators:
National Cancer Institute (NCI)
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
History of Changes
  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 Intervention Phase
Sarcoma
 Drug: indinavir sulfate
Drug: nelfinavir mesylate
Drug: paclitaxel
Drug: ritonavir
Drug: saquinavir mesylate
 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Eastern Cooperative Oncology Group:

Estimated Enrollment: 33
Study Start Date: June 1997
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Group Chair, Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT00003008     History of Changes
Other Study ID Numbers: CDR0000065583, E1D95, AMC-014
Study First Received: November 1, 1999
Last Updated: January 26, 2010
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Sarcoma, Kaposi
AIDS-Related Opportunistic Infections
Sarcoma
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Vascular Tissue
Opportunistic Infections
Infection
HIV Infections
Lentivirus Infections
Retroviridae Infections
 RNA Virus Infections
Parasitic Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Protease Inhibitors
Indinavir
Saquinavir
Ritonavir
Nelfinavir
Paclitaxel
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents

ClinicalTrials.gov processed this record on February 24, 2013