A Phase I Trial of Carboplatin and Abraxane in Patients With Solid Tumors
OBJECTIVES:
Primary
- Determine the maximum tolerated dose (MTD) of paclitaxel albumin-stabilized
nanoparticle formulation given once weekly for 3 weeks when administered with
carboplatin given once every 4 weeks.
- Determine the MTD of paclitaxel albumin-stabilized nanoparticle formulation given once
every 3 weeks when administered with carboplatin given once every 3 weeks.
- Determine the MTD of paclitaxel albumin-stabilized nanoparticle formulation given in
weeks 1 and 2 when administered with carboplatin given once every 3 weeks.
- Evaluate sequence-dependent effects on toxicity and pharmacokinetics in the combination
of paclitaxel albumin-stabilized nanoparticle formulation and carboplatin.
Secondary
- Explore the antitumor activity of paclitaxel albumin-stabilized nanoparticle
formulation given once weekly or once every 3 weeks.
OUTLINE: Patients are assigned to 1 of 3 treatment arms.
- Arm I: Patients receive carboplatin IV over 30 minutes on day 1 and paclitaxel
albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15.
Treatment repeats every 28 days for up to 6 courses in the absence of disease
progression or unacceptable toxicity.
- Arm II: Patients receive carboplatin IV over 30 minutes on day 1 and paclitaxel
albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1. Treatment
repeats every 21 days for up to 6 courses in the absence of disease progression or
unacceptable toxicity.
- Arm III: Patients receive carboplatin IV over 30 minutes on day 1 and paclitaxel
albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1 and 8.
Treatment repeats every 21 days for up to 6 courses in the absence of disease
progression or unacceptable toxicity.
Patients in arms I and II undergo blood sample collection periodically for pharmacokinetic
studies.
After completion of study treatment, patients are followed at 30 days.
Interventional
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose (MTD) of Abraxane
To determine the maximum tolerated dose (MTD) of Abraxane weekly days 1, 8, 15 with a carboplatin dose of AUC=6 given on day 1 of a 28 day cycle
28 days
No
Thomas E. Stinchcombe, MD
Principal Investigator
UNC Lineberger Comprehensive Cancer Center
United States: Federal Government
LCCC0412
NCT00520000
December 2004
September 2007
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