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Paclitaxel Compared With Doxorubicin in Treating Patients With Advanced AIDS-Related Kaposi's Sarcoma
This study is ongoing, but not recruiting participants.
First Received: November 1, 1999   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
AIDS Associated Malignancies Clinical Trials Consortium
Southwest Oncology Group
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003350
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether paclitaxel is more effective than doxorubicin in treating patients with advanced AIDS-related Kaposi's sarcoma.

PURPOSE: Randomized phase III trial to compare the effectiveness of paclitaxel with that of doxorubicin in treating patients who have advanced AIDS-related Kaposi's sarcoma.


Condition Intervention Phase
Sarcoma
Drug: paclitaxel
Drug: pegylated liposomal doxorubicin hydrochloride
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
Official Title: Phase III Study of Paclitaxel Versus Liposomal Doxorubicin for the Treatment of Advanced AIDS-Associated Kaposi's Sarcoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 240
Study Start Date: November 1998
Detailed Description:

OBJECTIVES:

  • Compare the effect of paclitaxel versus doxorubicin HCL liposome on progression-free survival and quality of life of patients with advanced AIDS-related Kaposi's sarcoma.
  • Compare the toxicity profile of intravenous paclitaxel with that of doxorubicin HCL liposome in these patients.
  • Compare the overall and complete response rate to these two treatments in these patients.
  • Evaluate the effect of intravenous paclitaxel as compared with doxorubicin HCL liposome on the clinical courses of HIV infection in patients with AIDS-related Kaposi's sarcoma.
  • Explore the relationship between viral load and response to the therapy for these patients.
  • Describe the relationship between "technical" response and the clinical benefit of therapy.

OUTLINE: This is a randomized study. Patients are randomized to receive either paclitaxel (arm I) or doxorubicin HCL liposome(arm II).

  • Arm I: Patients receive paclitaxel over 3 hours by intravenous infusion. Treatment course repeats every 2 weeks. Patients are evaluated every third course.
  • Arm II: Patients receive doxorubicin HCL liposome over 30-60 minutes by intravenous infusion. Treatment course is repeated every 3 weeks. Patients are evaluated before every odd course.

Patients in both arms continue treatment if there is no disease progression or unacceptable toxicity. Patients with complete response continue on study treatment for 2 courses beyond documented complete response.

Quality of life is assessed before, during, and after treatment.

Patients are followed every 3 months for the first 2 years, then every 6 months for years 2-5, and then annually thereafter.

PROJECTED ACCRUAL: There will be 240 patients (120 patients in each arm) accrued into this study over 24 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Serologically diagnosed HIV infection as documented by a positive ELISA and confirmed with a Western Blot, other federally approved HIV diagnostic test, or HIV viral load measurement
  • Histologically confirmed Kaposi's sarcoma, by biopsy, with any of the following:

    • Progressive cutaneous disease
    • Symptomatic oropharyngeal or conjunctival lesions
    • Any visceral involvement
    • Tumor-related lymphedema
    • Tumor-related ulceration or pain
  • Measurable disease

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 use of colony-stimulating factors)
  • Platelet count at least 50,000/mm^3
  • Hemoglobin at least 8 g/dL

Hepatic:

  • Bilirubin less than 1.5 times upper limit of normal (ULN)
  • SGOT or SGPT no greater than 5 times ULN

Renal:

  • Creatinine no greater than 2.1 mg/dL

Cardiovascular:

  • No history of cardiac insufficiency (New York Heart Association class II-IV heart disease)

Neurological:

  • No neuropsychiatric history of altered mental status

Other:

  • No known sensitivity to E. coli derived proteins
  • No active, untreated infection
  • No prior or concurrent malignancy other than curatively treated carcinoma in situ of the cervix or basal/squamous cell carcinoma of the skin
  • Not pregnant or nursing
  • Effective contraception required of all fertile patients

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Concurrent erythropoietin allowed
  • Prior filgrastim allowed

Chemotherapy:

  • No prior systemic chemotherapy for Kaposi's sarcoma

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior radiotherapy to marker lesions
  • At least 7 days since prior radiotherapy
  • No concurrent radiotherapy

Surgery:

  • Not specified

Other:

  • Must be on stable antiretroviral therapy for greater than 14 days prior to study
  • Concurrent maintenance therapy for opportunistic infections allowed
  • Concurrent antibiotics are allowed as long as dose and schedule have been stable for at least 1 week prior to study and absolute neutrophil count is stable
  • Patients with CD4 counts less than 200 cell/mm3 or less than 15% CD4 lymphocyte must be receiving some form of PCP prophylaxis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003350

Locations
United States, Alabama
AIDS Associated Malignancies Clinical Trials Consortium
Birmingham, Alabama, United States, 35233
Sponsors and Collaborators
Eastern Cooperative Oncology Group
AIDS Associated Malignancies Clinical Trials Consortium
Southwest Oncology Group
Investigators
Study Chair: Jamie Hayden Von Roenn, MD Robert H. Lurie Cancer Center
Study Chair: Jamie Hayden Von Roenn, MD Robert H. Lurie Cancer Center
Study Chair: Bryan Russell Leigh, MD University of California, Davis
  More Information

Additional Information:
Publications:
Von Roenn JH, Lee S, Cianfrocca M, et al.: Phase III study of paclitaxel (Pac) versus pegylated liposomal doxorubicin (PLD) for the treatment of advanced human immunodeficiency virus (HIV)-associated Kaposi's sarcoma (KS): an Eastern Cooperative Oncology Group (ECOG) and AIDS Malignancy Consortium. [Abstract] J Clin Oncol 25 (Suppl 18): A-20503, 726s, 2007.

Study ID Numbers: CDR0000066331, E-1D96, AMC-009, SWOG-E1D96, CPMC-IRB-9905
Study First Received: November 1, 1999
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00003350     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
AIDS-related Kaposi sarcoma

Study placed in the following topic categories:
Sarcoma, Kaposi
Antimitotic Agents
Doxorubicin
Herpesviridae Infections
Kaposi Sarcoma
Virus Diseases
Neoplasms, Connective and Soft Tissue
Anti-Bacterial Agents
Malignant Mesenchymal Tumor
Soft Tissue Sarcomas
Paclitaxel
Tubulin Modulators
Sarcoma
DNA Virus Infections
Antineoplastic Agents, Phytogenic

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Sarcoma, Kaposi
Antimitotic Agents
Antibiotics, Antineoplastic
Pharmacologic Actions
Doxorubicin
Herpesviridae Infections
Virus Diseases
Neoplasms, Connective and Soft Tissue
Neoplasms
Paclitaxel
Therapeutic Uses
Tubulin Modulators
Sarcoma
Neoplasms, Vascular Tissue
DNA Virus Infections
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on September 02, 2009