Paclitaxel in Treating Patients With AIDS-Related Kaposi's Sarcoma
This study has been completed.
Sponsor:
Eastern Cooperative Oncology Group
Collaborators:
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
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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:
Genetic and Rare Diseases Information Center resources:
Classic Kaposi Sarcoma
Malignant Mesenchymal Tumor
Soft Tissue 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) |
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
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
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
AIDS Associated Malignancies Clinical Trials Consortium
Investigators
| Study Chair: | Jamie Hayden Von Roenn, MD | Robert H. Lurie Cancer Center |
More Information
Additional Information:
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 Sarcoma, Kaposi DNA Virus Infections Herpesviridae Infections Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Vascular Tissue Virus Diseases |
Paclitaxel Antimitotic Agents Antineoplastic Agents Antineoplastic Agents, Phytogenic Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses Tubulin Modulators |
ClinicalTrials.gov processed this record on March 02, 2015