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	Treatment or Intervention	Phase
epidemic Kaposi's sarcoma	Procedure: chemotherapy  Drug: doxorubicin HCl liposome  Drug: paclitaxel	Phase III

Further Study Details: 

OBJECTIVES: I. 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. II. Compare the toxicity profile of intravenous paclitaxel with that of doxorubicin HCL liposome in these patients. III. Compare the overall and complete response rate to these two treatments in these patients. IV. 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. V. Explore the relationship between viral load and response to the therapy for these patients. VI. Describe the relationship between "technical" response and the clinical benefit of therapy.

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY 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

--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

--Patient Characteristics--

Age: 18 and over

Performance status: ECOG 0-2

Life expectancy: Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,000/mm3 (with or without use of colony-stimulating factors)
• Platelet count at least 50,000/mm3
• 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

Alabama
      AIDS Associated Malignancies Clinical Trials Consortium, Birmingham,  Alabama,  35233,  United States

Study chairs or principal investigators

Robert L. Comis,  Study Chair,  Eastern Cooperative Oncology Group   
Jamie Hayden Von Roenn,  Study Chair
Charles A. Coltman, Jr.,  Study Chair

Study ID Numbers:  CDR0000066331; E-1D96; CPMC-IRB-9905
Record last reviewed:  July 2003
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003350
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08