Paclitaxel Compared With Doxorubicin in Treating Patients With Advanced AIDS-Related Kaposi's Sarcoma

NCT00003350 | Completed Phase 3

• 4 other identifiers: NCI-2012-03149E1D96U10CA021115CDR0000066331
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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

Conditions

AIDS-related Kaposi Sarcoma

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  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.

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

Secondary Outcomes (7)

• Patients' health related quality of life (QOL) in terms of change in pain score, edema-related mobility, gastrointestinal (GI) symptoms and respiratory symptoms based on the total score from the Functional Assessment of HIV Infection (FAHI) v3

  Up to 8 years

• Overall response rate

  Up to 8 years

• Complete response rate

  Up to 8 years

• Toxicities in terms of nausea/vomiting, alopecia, neuropathy and mouth sores, based on the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0

  Up to 8 years

• Human immunodeficiency virus (HIV) infection assessed with respect to cluster of differentiation (CD)4 and CD8 lymphocyte subsets

  Baseline

Study Arms (2)

Arm I (paclitaxel)

EXPERIMENTAL

Patients receive paclitaxel over 3 hours by intravenous infusion. Treatment course repeats every 2 weeks. Patients are evaluated every third 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.

Drug: paclitaxel; Other: laboratory biomarker analysis; Procedure: quality-of-life assessment

Arm II (pegylated liposomal doxorubicin hydrochloride)

EXPERIMENTAL

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.

Drug: pegylated liposomal doxorubicin hydrochloride; Other: laboratory biomarker analysis; Procedure: quality-of-life assessment

Interventions

paclitaxel DRUG

Given IV

Also known as: Anzatax, Asotax, TAX, Taxol

Arm I (paclitaxel)

pegylated liposomal doxorubicin hydrochloride DRUG

Given IV

Also known as: CAELYX, Dox-SL, DOXIL, doxorubicin hydrochloride liposome, LipoDox

Arm II (pegylated liposomal doxorubicin hydrochloride)

laboratory biomarker analysis OTHER

Correlative studies

Arm I (paclitaxel); Arm II (pegylated liposomal doxorubicin hydrochloride)

quality-of-life assessment PROCEDURE

Ancillary studies

Also known as: quality of life assessment

Arm I (paclitaxel); Arm II (pegylated liposomal doxorubicin hydrochloride)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 measurement
• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Eastern Cooperative Oncology Group

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

AIDS-related Kaposi sarcoma

Interventions

Paclitaxel; Taxes; liposomal doxorubicin

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Economics; Health Care Economics and Organizations

Study Officials

• Jamie Von Roenn

  Eastern Cooperative Oncology Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: July 11, 2003
• Study Start: March 1, 1999
• Primary Completion: March 1, 2007
• Last Updated: January 10, 2013

Record last verified: 2013-01

Locations

US (1)