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:

MedlinePlus related topics: Kaposi's Sarcoma Soft Tissue Sarcoma

Drug Information available for: Paclitaxel Saquinavir Saquinavir mesylate Indinavir Ritonavir Indinavir sulfate Nelfinavir Nelfinavir Mesylate

Genetic and Rare Diseases Information Center resources: Malignant Mesenchymal Tumor Soft Tissue Sarcoma Kaposi Sarcoma

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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


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 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 Indinavir Nelfinavir 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

ClinicalTrials.gov processed this record on September 26, 2016

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