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

Tracking Information

First Received Date ^ICMJE

November 1, 1999

Last Updated Date

January 26, 2010

Start Date ^ICMJE

June 1997

Primary Completion Date

June 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00003008 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Pilot Study to Evaluate the Potential Interactions Between Paclitaxel and Protease Inhibitors in Patients With AIDS-Related Kaposi's Sarcoma

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.

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 Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Primary Purpose: Treatment

Condition ^ICMJE

Sarcoma

Intervention ^ICMJE

Drug: indinavir sulfate
Drug: nelfinavir mesylate
Drug: paclitaxel
Drug: ritonavir
Drug: saquinavir mesylate

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

June 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00003008

Other Study ID Numbers ^ICMJE

CDR0000065583, E1D95, AMC-014

Has Data Monitoring Committee

Responsible Party

Group Chair, Eastern Cooperative Oncology Group

Study Sponsor ^ICMJE

Eastern Cooperative Oncology Group

Collaborators ^ICMJE

National Cancer Institute (NCI)
AIDS Associated Malignancies Clinical Trials Consortium

Investigators ^ICMJE

Study Chair:

Jamie Hayden Von Roenn, MD

Robert H. Lurie Cancer Center

Information Provided By

Eastern Cooperative Oncology Group

Verification Date

January 2010

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

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