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
|
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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 |
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 : | 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 |


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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
United States, Alabama | |
University of Alabama at Birmingham Comprehensive Cancer Center | |
Birmingham, Alabama, United States, 35294-3300 |
Study Chair: | Jamie Hayden Von Roenn, MD | Robert H. Lurie Cancer Center |
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 |