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Pilot Study to Evaluate the Potential Interactions Between Paclitaxel and Protease Inhibitors in Patients With AIDS-Related Kaposi's Sarcoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Sarcoma

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Trial Information

Pilot Study to Evaluate the Potential Interactions Between Paclitaxel and Protease Inhibitors in Patients With AIDS-Related Kaposi's Sarcoma


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Jamie Hayden Von Roenn, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Robert H. Lurie Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000065583

NCT ID:

NCT00003008

Start Date:

June 1997

Completion Date:

Related Keywords:

  • Sarcoma
  • AIDS-related Kaposi sarcoma
  • recurrent Kaposi sarcoma
  • Sarcoma, Kaposi
  • AIDS-Related Opportunistic Infections
  • Sarcoma

Name

Location

University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, Alabama  35294-3300