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

Sponsor

Eastern Cooperative Oncology Group (Other)

Overall Status

Completed

CT.gov ID

NCT00003008

Collaborator

National Cancer Institute (NCI) (NIH), AIDS Associated Malignancies Clinical Trials Consortium (Other)

Enrollment

Location

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Sarcoma	Drug: indinavir sulfate Drug: nelfinavir mesylate Drug: paclitaxel Drug: ritonavir Drug: saquinavir mesylate	Phase 2

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

33 participants

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

Study Start Date :

Jun 1, 1997

Actual Primary Completion Date :

Jun 1, 2006

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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