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Phase III Study of Paclitaxel Versus Liposomal Doxorubicin for the Treatment of Advanced AIDS-Associated Kaposi's Sarcoma

Phase 3
18 Years
Not Enrolling
AIDS-related Kaposi Sarcoma

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Trial Information

Phase III Study of Paclitaxel Versus Liposomal Doxorubicin for the Treatment of Advanced AIDS-Associated Kaposi's Sarcoma


I. To compare the effect of therapy with paclitaxel to therapy with liposomal doxorubicin on
progression-free survival and on global assessment of quality of life of subjects with
advanced AIDS-related K.S.

II. To compare the toxicity profile of intravenous paclitaxel with liposomal doxorubicin in
patients with advanced AIDS-related K.S.

III. To compare the overall and complete response rate of intravenous paclitaxel with
liposomal doxorubicin in patients with advanced AIDS-related K.S.

IV. To evaluate the effect of intravenous paclitaxel as compared with therapy with liposomal
doxorubicin on the clinical course of HIV infection in patients with advanced AIDS-related
K.S., by monitoring CD4 and CD8 lymphocyte subsets, HIV viral load and the incidence and
type of opportunistic infections.

V. To explore the relationship between viral load and response to the therapy for patients
with AIDS-related K.S.

VI. To describe the relationship between "technical" response as measured by the current KS
response criteria and the clinical benefit of therapy as measured by the revised KS clinical
benefit criteria.

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.

Inclusion Criteria:

- Serologic diagnosis of HIV infection as documented by a positive ELISA and confirmed
with a western blot, other federally approved HIV diagnostic test, or HIV viral load

- Biopsy-proven, measurable Kaposi's sarcoma with any of the following:

- Progressive cutaneous disease

- Symptomatic oropharyngeal or conjunctival lesions

- Any visceral involvement

- Tumor-related lymphedema

- Tumor-related ulceration or pain

- NOTE: All patients must have measurable disease; baseline measurements must be
obtained < 4 weeks prior to registration

- ECOG performance status 0-2

- ANC >= 1000/mm³ (with or without the use of colony-stimulating factors)

- Platelet count >= 50,000/mm³

- Hemoglobin >= 8 gm/dL

- Bilirubin < 1.5 x the upper limit of normal (unless elevation is due to Crixivan
administration with isolated elevation in conjugated bilirubin)

- SGOT or SGPT =< 5 x the upper limit of normal

- Creatinine =< 2.1 mg/dl

- Women must not be pregnant or lactating due to potential toxicity of therapy

- Women of childbearing potential and sexually active men must be advised to use an
accepted and effective method of contraception due to potential toxicity of therapy

- No prior systemic cytotoxic chemotherapy for Kaposi's sarcoma

- Prior radiation therapy must have been discontinued >= 7 days prior to randomization
and must NOT have been delivered to marker lesions; (NOTE: Radiation therapy will not
be permitted during study treatment)

- No active, untreated infection (no new opportunistic infectious complications within
the previous week requiring a change in antibiotics); maintenance therapy for
opportunistic infections will be allowed

- No prior or concomitant malignancy other than curatively treated carcinoma in situ of
the cervix or basal/squamous cell carcinoma of the skin

- No neuropsychiatric history or altered mental status that might prevent informed
consent or affect the ability of the patient to comply with the study

- Institutions must ask patients to participate in the quality of life portion of the
protocol; however, patients may decline participation in this component of the study
and still be eligible; the reason for refusal or inability to complete the QOL
assessments must be documented in the Assessment Compliance Form (#596)

- Must not be known to be sensitive to E. coli derived proteins

- No history of cardiac insufficiency (NY Heart Association status >= 2)

- Patients must be on stable (no change in drugs or doses) antiretroviral therapy for
greater than 14 days prior to study; a combination regimen is required; ideally this
will be a protease inhibitor containing triple therapy regimen

- Patients must give signed, written informed consent

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Description:

The group sequential method by O'Brien and Fleming for the two-sided test will be used. The significance level will be based on the type I error spending function of Lan and DeMets such that the overall significance level will be maintained at 0.05.

Outcome Time Frame:

Time from randomization to progression or to death from any cause, assessed up to 8 years

Safety Issue:


Principal Investigator

Jamie Von Roenn

Investigator Role:

Principal Investigator

Investigator Affiliation:

Eastern Cooperative Oncology Group


United States: Food and Drug Administration

Study ID:




Start Date:

March 1999

Completion Date:

Related Keywords:

  • AIDS-related Kaposi Sarcoma
  • Acquired Immunodeficiency Syndrome
  • Sarcoma, Kaposi
  • AIDS-Related Opportunistic Infections
  • Sarcoma



Eastern Cooperative Oncology Group Boston, Massachusetts  02215