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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eastern Cooperative Oncology Group
• Collaborators: AIDS Associated Malignancies Clinical Trials Consortium; National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Indinavir; Nelfinavir; Paclitaxel; Ritonavir; Saquinavir

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