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

Eastern Cooperative Oncology Group

Status and phase: Completed; Phase 2

Conditions: Sarcoma

Treatments: Drug: nelfinavir mesylate; Drug: indinavir sulfate; Drug: paclitaxel; Drug: ritonavir; Drug: saquinavir mesylate

Study type: Interventional

Funder types: Other; NETWORK; NIH

Identifiers

NCT00003008

E1D95

CDR0000065583

AMC-014

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 estimated patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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